Search a drug...

Search symptoms...

Drug Injury Search

Are you the victim of a drug injury? Interested in knowing if any injuries are linked to a drug you are taking? Drug injury search can help. Using this search engine, you will be able to access important drug injury information on both prescription and over-the-counter medications in just a matter of seconds. Simply enter the name of the drug you are searching for to find out if it has been associated with any injuries, recalls or lawsuits.



Injured By This Drug. Click Here
Study Questions Off-Label Use Of Atypical Antipsychotics
Although atypical antipsychotics—<"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa, Abilify, <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal, and <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel—are being used more and more for an array of off-label conditions, the drugs are only effective for a few such diagnoses.

A study reviewing prior Zyprexa, Abilify, Risperdal, and Seroquel research suggests that while atypical antipsychotics are used for a number of off label diagnoses, the drugs are not effective for most and there is a variance in benefits and adverse reactions, according to a Journal of the American Medical Association (JAMA) article, said Science Daily. The article appears in the September 28 issue.

Antipsychotics are approved for serious psychiatric conditions; however, the drugs can be used at physician discretion and are being used for a range of disorders. Some of these other uses have seen recent approval by the U.S. Food and Drug Administration (FDA); many have not.

"Atypical antipsychotic medications are approved for marketing and labeling by the U.S. Food and Drug Administration (FDA) for treating schizophrenia, bipolar disorder, and depression under drug-specific circumstances. The use of atypical antipsychotic medications is rapidly increasing in the United States, with 1 study estimating an increase from 6.2 million to 14.3 million treatment visits between 1995 and 2008. The estimated use of these drugs for off-label indications, meaning those without FDA approval for these indications, doubled during this period," said background information in the article, according to Science Daily.

Alicia Ruelaz Maher, M.D., of RAND Health, and her team conducted a systemic review and meta-analysis of the efficacy and adverse events connected to the off-label use of atypical antipsychotics when used to treat behavioral symptoms in patients diagnosed with dementia, anxiety, obsessive-compulsive disorder (OCD), eating disorders, post traumatic stress disorder (PTSD), insomnia, personality disorders, depression, and substance abuse, said Science Daily.

Medical literature was reviewed for controlled trials that compared Zyprexa (olanzapine), Abilify (aripiprazole), Risperdal (risperidone), Seroquel (quetiapine), Geodon, Zeldox (ziprasidone), Safris and Sycrest (asenapine), Fanapt (iloperidone), and Invega (paliperidone) to a placebo or other pharmacotherapy for adult off-label diagnoses. Observational studies with greater-than-1,000 sample sizes reviewed for adverse reactions, noted Science Daily.

The team found 162 trials with efficacy outcomes and 231 trials or large observational studies with adverse events. "The benefits and harms vary among atypical antipsychotic medications for off-label use," the authors wrote, said Science Daily. Modest benefits were realized, said WebMD, for some diagnoses—dementia, generalized anxiety disorder, PTSD, and OCD—but not for eating disorders or substance abuse. "We didn't see dramatic benefits," said Dr. Ruelaz Maher, MD.

The study did reveal serious risks. For instance, elderly dementia patients taking atypical antipsychotics suffered from an increased risk of death versus patients taking a placebo, said WebMD. The findings—an analysis of 15 studies in which 3.5% percent of patients taking the drugs died—translate into one death for every 87 elderly dementia patients taking atypical antipsychotics, noted WebMD. Other side effects included serious sedation, heart, involuntary movement, and urinary tract infection risks. In younger adults, the drugs were linked to increased appetite and weight gain, sedation, fatigue, involuntary movements, and restlessness.

We’ve long written about the links between antipsychotic medications and a number of adverse reactions, most recently concerning Seroquel, Abilify, Zyprexa, and Risperdal and a lack of proof of efficacy and associations with some serious side effects. Atypical antipsychotics have been the focus of thousands of lawsuits; the drug class is also the single, largest spotlight for lawsuits filed under the federal False Claims Act. Every key drug company selling atypical antipsychotics have either settled lawsuits in the hundreds of millions of dollars or are the subject of probes concerning the massaging of results or use of “questionable” marketing, noted Science Daily previously.

 


Antipsychotic Drugs Ineffective in Treating PTSD Symptoms, Study Finds
A new, six-month study found that that antipsychotic medications such as Risperdal, don’t work all that well in resolving symptoms associated with Post-Traumatic Stress Disorder (PTSD), a dangerous disorder very commonly seen in combat veterans.

Veterans Affairs (VA) described PTSD as an anxiety disorder linked to a traumatic event in which the sufferer believes his/her life, or the lives of others, are in danger, common in combat situations. Symptoms of PTSD include sleeplessness, nightmares, restlessness, and an acute startle response, to name just some. The effects of PTSD can be debilitating.

Risperdal (risperidone), used in the treatment of PTSD in combat veterans, might not be doing much to reduce severity of the disorder, according to the new, randomized, controlled study, said MSNBC, worked no better than the placebo in mitigating symptoms in long-term PTSD sufferers or those who continued to suffer from symptoms after antidepressant therapy. The medication did not minimize depression and anxiety, said the researchers. The study appears in the current Journal of the American Medical Association.

“PTSD is the most common—and most costly to treat—disorder seen by the VA psychiatry services,” said lead author, Dr. John H. Krystal, professor and chair of the department of psychiatry at Yale University and director of the clinical neuroscience division of the VA’s National Center for PTSD. “It’s a huge problem,” Dr Krystal added, reported MSNBC.

The U.S. Food and Drug Administration (FDA) has only approved two medications for the treatment of PTSD: Paxil and Zoloft; however, they are not always effective. Specifically, these antidepressants don’t do much to help people who have undergone multiple traumas or who suffer from chronic PTSD, said Krystal, wrote MSNBC. Because of this, physicians have tried medications such as Risperdal (risperidone) to augment antidepressant use.

Risperdal is an antipsychotic medication approved for the treatment of schizophrenia, bipolar disorder, and irritability linked to autism disorder, said MSNBC. In 2009, some 87,000 PTSD-diagnosed veterans were prescribed an antipsychotic prescription; about 94 percent received a second-generation antipsychotic, such as Risperdal, MSNBC added. “So here we have the situation where one of the most commonly prescribed medications for the treatment of PTSD turns out not to be effective in reducing the overall severity of PTSD or improving other types of outcomes, such as quality of life,” Krystal said. “Which really gives you pause,” Krystal noted, reported MSNBC.

The study looked at 247 veterans diagnosed with military-related PTSD; half received risperidone and half received placebos; those on antidepressants continued those drugs in addition to risperidone, said MSNBC. Patients taking risperidone fared no better than patients taking placebos in reducing the severity of symptoms. Side effects including weight gain, sleepiness, and drowsiness were observed in those taking risperidone.

“We fully expected we would find it to be effective on the basis of preliminary studies that found risperidone effective and because it was so widely prescribed,” Krystal said. “But we found that it was not only not better than placebo at reducing overall symptoms, but also it was not better in reducing anxiety, depression, or in improving quality of life,” MSNBC reported.

Dr. Ian Cook, the Miller professor of psychiatry at the University of California, Los Angeles said “PTSD can be such a dangerous illness…. People really need to get treatment. It can lead to suicide. It can lead to violence when someone is having a flashback. People need to get care,” according to MSNBC

 


Antipsychotics Still Used for Parkinson’s Despite Risks
Despite black box warnings—the strongest the U.S. Food and Drug Administration (FDA) places on medications—physicians continue to prescribe <"http://www.yourlawyer.com/practice_areas/defective_drugs">antipsychotic medications such as Risperdal (risperidone) and Zyprexa (olanzapine) for their patients with Parkinson’s disease. The drugs have been linked to higher risks of death in patients with dementia, noted WebMD, a common comorbidity in those with Parkinson’s.

"My sense is that the black box warnings don't factor into decision making," said study researcher Daniel Weintraub, MD, an associate professor of psychiatry at the University of Pennsylvania, quoted WebMD. The study is published in the Archives of Neurology.

The black box warns that the medications are linked with increased risks of fatalities for people suffering from dementia; as a matter-of-fact, some of the more common antipsychotics can intensity Parkinson’s disease symptoms, noted WebMD.

About 60 percent of those with Parkinson’s will experience some type of psychosis, according to the recent study, said WebMD. Weintraub and his team, found that about half of those Parkinson’s patients with psychosis were treated with antipsychotics.

Risperdal and Zyprexa have not been proven efficacious in the treatment of Parkinson’s; however, about 30 percent of those with Parkinson’s and psychosis take these drugs while Clozaril (clozapine), the only drug proven effective and well-tolerated in the treatment of psychosis in those with Parkinson’s is only prescribed to about 2 percent of those patients, said WebMD.

"The gold standard treatment is also one of the most impractical treatments," said neurologist Hubert Fernandez, MD, a Parkinson's specialist at the Cleveland Clinic's Center for Neurological Restoration, quoted WebMD. But, Clozapine is not perfect and comes with a rare and sometimes fatal side effect that requires patients have blood levels regularly checked. Because of this, physicians tend to shy away from the drug.

Other alternatives don’t offer meaningful solutions. For instance, Abilify (aripiprazole), is not well tolerated by Parkinson's patients and Seroquel’s (quetiapine) efficacy has not been proven despite three studies. "Quetiapine is the No. 1 choice without clear evidence that it's effective," said Weintraub. In other words, although the least effective in a number of studies, Seroquel is routinely prescribed to Parkinson’s patients.

Seroquel was introduced in 1997 to treat psychotic disorders, schizophrenia, and bipolar disorder. In recent years, AstraZeneca has faced over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk. Also, earlier this year we reported that U.S. health regulators ordered cautions be added to ALL antipsychotic drug labels regarding their risk of abnormal muscle movements (extrapyramidal symptoms or EPS) and withdrawal syndromes in newborns when used in pregnancy. The new cautions will apply to older and new generation antipsychotics, including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax, according to an FDA alert.

Atypical antipsychotics, like Seroquel, are favored by many doctors and patients because they carry a decreased risk of side effects related to loss of motor control, a major problem with older “typical” antipsychotics. But Seroquel and similar drugs carry other safety risks, such as increased risks for weight gain and diabetes. In 2003, the FDA required the makers of atypical antipsychotics to re-label them to include warnings regarding their risk of hyperglycemia and diabetes mellitus. In 2005, the FDA also warned that such drugs increased the risk of death among elderly people.

 


Risperdal Recalled For Odor
Ortho-McNeil-Janssen Pharmaceuticals Inc., a division of the beleaguered drug giant Johnson & Johnson, just issued a recall of its antipsychotic medication, <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal, and Risperdal’s generic version; both over an odor believed to be linked to a chemical preservative used in wood shipping pallets, said The Associated Press (AP). This recall is just one of many in a seemingly endless going series of Johnson & Johnson recalls on which we have written.

Ortho-McNeil-Janssen said patients should not stop taking their medications, but if an uncharacteristic odor is noticed, patients should return the tablets to their pharmacy and refer questions to their healthcare professional, said the AP, which noted that both Risperdal and risperidone are used in the treatment of schizophrenia in adults and teenagers and can also be used as a short-term bipolar mania treatment.

Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.

According to Johnson & Johnson’s Ortho-McNeil-Janssen, the recalled lot included 16,000 bottles of Risperdal in 3-milligram tablets that were shipped between August 2010 and February, said the AP. Some 1,600 bottles remain on the market.

The recall also involves a lot of 24,000 bottles of the 2-milligram generic risperidone tablets, said the AP. That lot was shipped between November 2010 and January 1; the drug maker believes less than 1,200 bottles of the recalled lot are still on the market, said the AP, which noted that Ortho-McNeil-Janssen said the recall is limited to the United States and Puerto Rico.

In March, we wrote that Johnson & Johnson’s McNeil Consumer Healthcare unit issued another recall of musty-smelling Tylenol that involved 134,000 150-count bottles of Tylenol 8-Hour Extended Release Caplets. That recall also had to do with tribromoanisole (TBA), as well as 2,4,6-trichloroanisole (TCA).

TBA has been behind other recalls of musty-smelling Tylenol in the past. For instance, in March we wrote about another Johnson & Johnson recalled medication manufactured in its Puerto Rico plant. The March recall had to do with 11,700 bottles of its HIV/AIDS medication, Prezista, in a number of countries following complaints of the drug releasing an offensive odor. At the time, Johnson & Johnson said it had taken steps to minimize TBA contamination that involved mandating its suppliers confirm that TBA pallets are not used.

Johnson & Johnson has, since September 2009, announced at least two dozen recalls involving over 300 million bottles of nonprescription medicines as well as prescription medications, contact lenses, and over 90,000 hip replacement devices, noted the AP. Recalls have been called for reasons that range, said the AP, the gamut from “nauseating odors and incorrect levels of active ingredient to contaminants in medicines and uncomfortable hip replacements requiring repeat surgery.”

 


Johnson & Johnson Ordered to Pay Millions for Deceptive Risperdal Marketing
Ortho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson, was just ordered to pay over $327 million in penalties over how it marketed <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal, allegedly using deception in its claims that the controversial antipsychotic is a safer, better version than what the competition offers. Risperdal (Generic: Risperidone) is a newer atypical antipsychotic drug prescribed to help people combat Schizophrenia and Bi-Polar Disorder.

We just reported that drug giant, Johnson & Johnson earmarked an unknown sum of money to resolve its Risperdal woes with the federal government—a separate action; federal prosecutors are seeking about $1 billion in connection to allegations of illegal marketing of the antipsychotic medication.

According to Judge Roger Couch of Spartanburg, South Carolina, Ortho-McNeil-Janssen violated South Carolina’s consumer protection laws on an ongoing, routine basis by writing to doctors in 2003 promoting Risperdal as better than its competitor’s drugs; the letters also contained what was described as deceptive information in Risperdal’s warning label, wrote Bloomberg News. Judge Couch’s 17-page ruling also stated that executives at Ortho-McNeil-Janssen, quoted Bloomberg News, “allowed the profit-at-all-costs mentality to cloud” their judgment concerning how the drug was marketed and labeled.

Ortho-McNeil-Janssen disagrees, saying they will appeal the order, and arguing it fully disclosed health risks associated with Risperdal and appropriately conducted the drug’s marketing. “We don’t believe that the dissemination of an FDA- approved package insert constitutes a violation of the South Carolina Trade Practices Act,” said Kara Russell, a Janssen spokeswoman, quoted Bloomberg News. “We do not believe the ruling can be upheld on appeal,” Russell added in her emailed statement.

Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.

South Carolina’s case concerned claims made by Johnson & Johnson and Ortho-McNeil-Janssen in its 2003 correspondence sent to some 700,000 United States Physicians, said Bloomberg News. The U.S. Food and Drug Administration (FDA) responded with a warning letter that stated that Johnson & Johnson made false and misleading claims that played down the possibly fatal outcomes related to diabetes and that also exaggerated Risperdal’s benefits versus its competition.

Defective Risperdal labeling involved at least 772,000 prescriptions in South Carolina alone from 1994 to 2007; was involved in 183,144 sales calls made to physicians by the drug maker’s representative; and appeared on 496,545 distributed sample boxes, according to the state’s lawyers, said Bloomberg News. Judge Couch said that he found the Risperdal letter that was distributed to South Carolina physicians to be a “clever effort” to “manipulate the message” about Risperdal, quoted Bloomberg News.

Judge Couch found that penalties were in order for about 7,180 of the letters and 36,372 cases in which Risperdal representative used the document to market the drug in person, said Bloomberg News, citing court records. Penalties were based on the rate of about $4,000 per violation of South Carolina’s consumer-protection laws, according to Judge Couch’s ruling. The judge also said that 509,499 sample boxes of Risperdal distributed in North Carolina contained deceptive labeling that called for penalties; North Carolina was awarded $152.8 million in penalties, at a rate of $300 per violation.

 


Johnson & Johnson Risperdal Settlement Could Cost $1 Billion
We recently wrote that beleaguered drug giant, Johnson & Johnson earmarked an unknown sum of money to resolve its <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal woes with the federal government. Good thing. The Wall Street Journal reports that federal prosecutors are looking for about $1 billion in connection with allegations of illegal marketing of the antipsychotic medication. Risperdal (Generic: Risperidone) is a newer atypical antipsychotic drug prescribed to help people combat Schizophrenia and Bi-Polar Disorder.

This settlement is considered one of the largest related to off-label marketing and is expected to affect Johnson & Johnson’s bottom line this quarter. The federal investigation has been ongoing since 2004 and has been looking into Janssen Pharmaceutica, a Johnson & Johnson unit, accused of inappropriately marketing Risperdal, according to the drug maker’s filings with the U.S. Securities and Exchange Commission (SEC), said the Journal.

This week, Johnson & Johnson announced it set aside an undisclosed amount for a potential settlement and would “likely” have to contend with civil and criminal actions if it refused to settle, wrote the Journal. As NJ.com recently pointed out, this probe is just one connected to Risperdal that Johnson & Johnson is facing; there are a number of related lawsuits which have been filed by attorneys general in a variety of states.

According to NJ.com, The Office of the Inspector General of the U.S. Office of Personnel Management issued its first subpoena on the matter to Ortho-McNeil-Janssen Pharmaceuticals in 2004. In early 2010, the government sought more details on the sale and marketing of Risperdal and Invega, another schizophrenia drug, said NJ.com. The investigation is looking at how these drugs were allegedly marketed for off label uses, said the SEC filing. Drugs can be prescribed off-label by physicians; however, drug makers are legally banned from marketing drugs for uses not approved by the U.S. Food and Drug Administration (FDA).

An insider told the Journal that government prosecutors are looking to the $1.4 billion Eli Lilly & Co. 2009 settlement over illegal Zyprexa marketing, its antipsychotic medication, as a base point said the Journal. The timeframe involved with those activities was longer than in this case. Another 2009 settlement, this one with Pfizer Inc., is considered the largest at $2.3 billion to settle off label allegations concerning Bextra, a painkiller that has since been pulled from the market, wrote the Journal.

Specific federal allegations have not been released; however, it has been noted that Risperdal has been approved for schizophrenia and bipolar disorder and should not be used for the treatment of dementia-related psychosis, including in the elderly who experienced increased risks of death from Risperdal, explained the Journal. The J&J case began as a whistleblower case—one in which employees can be compensated for recovered government funds. In this case, one issue at stake is the wasted Medicaid and government funds linked to off label marketing, said the Journal.

We recently wrote that prosecutors claim Risperdal was used to control anxiety among nursing home patients with dementia and Alzheimer’s disease, an off-label use. Prosecutors also allege that Johnson & Johnson’s conduct caused false or fraudulent claims to be filed with Medicaid, the public health program for the poor and disabled.

Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches. Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.

 


Johnson & Johnson Recalls HIV Drug
As if the unprecedented frequency of recalls, the global DePuy hip replacement device debacle, and the Risperdal scandal were not enough, Johnson & Johnson is making headlines again for its HIV/AIDS medication, <"http://www.yourlawyer.com/practice_areas/defective_drugs">Prezista. According to The Wall Street Journal, the drug giant just recalled 11,700 bottles of Prezista in a number of countries following complaints of the drug releasing an offensive odor. This is, by the way, not the first time a Johnson & Johnson drug has been recalled for bad smells.

Johnson & Johnson said it received four consumer reports of musty or moldy odors in the medication, later discovering a chemical in five batches of products sold in the United Kingdom, Ireland, Germany, Austria, and Canada, said the Journal. The chemical involved, said The Journal, is 2,4,6 tribromoanisole (TBA), a byproduct of a chemical preservative used on wood pallets on which products are transported and stored.

Recalls have been implemented at both the wholesale and retail levels and involve 9,000 bottles of 400-milligram tablets and 2,700 bottles of 600mg tablets, said Mark Wolfe, spokesman for Johnson & Johnson, wrote the Journal. According to the drug maker, less than 2,000 bottles remain in the countries in which recalls were implemented and, in the UK, only the 400-mg tablets are involved; in Canada one lot of the 600-mg medication contained TBA, and less than 300 affected bottles are on the Canadian market, said The Journal.

Wolfe said the firm is talking with regulatory authorities in Canada to implement a plan and noted that patients should not stop taking their medication, wrote The Journal. Johnson & Johnson said that while TBA is not toxic, it can create unpleasant odors and lead to “temporary gastrointestinal” issues; no serious adverse events have been reported in connection to the TBA-tainted Prezista, said The Journal. The drug maker is conducting an investigation into the origin of the contamination.

In March, we wrote that Johnson & Johnson’s McNeil Consumer Healthcare unit issued another recall of musty-smelling Tylenol that involved i34,000 150-count bottles of Tylenol 8 Hour Extended Release Caplets. That recall also had to do with TBA, as well as 2,4,6-trichloroanisole (TCA). TBA has been behind other recalls of musty-smelling Tylenol in the past; however, according to a Dow Jones Newswires report at the time, TCA was not cited by Johnson & Johnson in prior recalls.

This recall involves medication manufactured at Johnson & Johnson’s Puerto Rico plant, said Wolfe. The Journal also noted that Johnson & Johnson had taken steps to minimize TBA contamination that involved mandating its suppliers confirm that TBA pallets are not used.

The seemingly endless string of recalls have cost Johnson & Johnson more than $900 million in sales over the past year with over 20 recalls issued by its McNeil Consumer Healthcare division involving upwards of 200 million bottles of drugs. The company’s Ortho-McNeil-Janssen Pharmaceuticals division recalled prefilled Invega Sustenna syringes; Ethicon recalled a number of surgical drainage products over sterility issues; and Johnson & Johnson recalls have involved two DePuy hip replacement implants sold by its DePuy Orthopaedics unit, insulin pump cartridges made by its Animas unit, 1-Day Acuvue TruEye contact lenses, and Simponi injection pens.

 


Johnson & Johnson Makes Provisions for Risperdal Settlement
Drug maker Johnson & Johnson has put funds aside toward a possible <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal (Generic: Risperidone) settlement. The sum remains unknown and is being earmarked for penalties that have been racking up over the course of an investigation that has been ongoing for seven years, said NJ.com.

The charges are a result of alleged unapproved marketing of the schizophrenia medication, wrote NJ.com, citing documents filed with federal security regulators.

Risperdal is a newer atypical antipsychotic drug prescribed to help people combat Schizophrenia and is manufactured by Jannsen Pharmaceuticals, a division of Johnson & Johnson.

According to NJ.com, The Office of the Inspector General of the U.S. Office of Personnel Management issued its first subpoena on the matter to Johnson & Johnson’s subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, in 2004. In early 2010, the government was looking for more details on the sales and marketing of Risperdal and Invega, another schizophrenia drug, said NJ.com.

The investigation is looking at how these two drugs were allegedly marketed for unapproved or off-label uses, said the Securities and Exchange Commission (SEC) filing. Drugs can be prescribed for off-label uses by physicians; however, drug makers are legally banned from marketing drugs for uses not approved by the U.S. Food and Drug Administration (FDA).

As NJ.com pointed out, this governmental probe is only just one connected to Risperdal that Johnson & Johnson is facing; there are a number of related lawsuits which have been filed by attorneys general in a variety of states.

For instance, we recently wrote that prosecutors claim Risperdal was used to control anxiety among nursing home patients with dementia and Alzheimer’s disease, an off-label use of the drug. In that case, Johnson & Johnson was charged with paying kickbacks to the Omnicare nursing home chain for the purpose of increasing the use of its drugs at the chain's homes. According to allegations contained in a complaint filed by the U.S. Attorneys office in Boston, from 1999 to 2004 Johnson & Johnson paid kickbacks to Omnicare in rebates, grants, and educational funding, to name a few. Among many other issues, the complaint repeatedly mentions internal Johnson & Johnson emails and statements detailing the Omnicare relationship. The government claims those documents show that Johnson & Johnson came to see Omnicare pharmacists as an extension of its sales force.

Prosecutors also allege that Johnson & Johnson’s conduct caused false or fraudulent claims to be filed with Medicaid, the public health program for the poor and disabled.

Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain, and headaches.

Risperdal has also been linked to diabetes, Neuroleptic Malignant Syndrome (NMS), Stroke, and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal.

 


Johnson & Johnson to Disclose Payments to Doctors
Earlier this year we wrote that Johnson & Johnson was facing charges that it paid kickbacks to Omnicare, one of the nation’s largest nursing home chains, in order to push drugs like <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal and <"http://www.yourlawyer.com/topics/overview/levaquin">Levaquin at the chain’s facilities. Now, The Wall Street Journal is reporting that the drug giant is, for the first time, disclosing payments made to physicians.

Although the move is likely being made to increase information about the drug maker’s marketing strategy practices, The Journal notes that finding information on Johnson & Johnson's Website might take some hunting. For instance, payments on individual doctors does not appear in one place but appears across no less than three reports on Johnson & Johnson’s pharmaceutical unit’s operating companies’ Websites. Also, pointed out The Journal, public disclosure or the total numbers indicating what was spent and how many doctors were paid is not being provided by Johnson & Johnson, although other drug makers have listed this information.

"It's not all in one place," said Allan Coukell, director of the Pew Prescription Project, a group that has fought for broader disclosure of industry’s payouts to doctors, said The Journal. "We would have rather seen the multiple Johnson & Johnson sites consolidated into one. That said, I give them credit for doing what they've done. We applaud any company that takes voluntary steps towards this kind of disclosure," quoted The Journal.

Mark Wolfe, a Johnson & Johnson spokesman said that the firm’s pharmaceutical divisions have been posting doctor names and amounts paid on a variety of Johnson & Johnson Websites beginning June 30 and covering payments made the first three months of 2010, wrote The Journal.

According to Johnson & Johnson information, payments it made to doctors from its Ortho-McNeil-Janssen unit totaled $1.76 million, said The Journal, which noted the calculations were made by Obsidian HDS LLC, an aggregator of physician-payment data. Johnson & Johnson's Cento or Ortho Biotech unit total payout was $658,111 and the total paid out by the Tribute unit was $433,250, according to The Journal calculations.

We’ve long been saying so, and the issue has made headlines many times in recent months regarding the ties between Big Parma and health professionals, with many complaining that the transparency between the two is not sufficiently broad and point to a potential bias in which patients are often not the prime concern.

Drug makers, pointed out The Journal, pay physicians, researchers, and other health care professionals to consult on “research, safety surveillance, and other matters, and to speak to other doctors about uses of its products,” explained The Journal.

Meanwhile, a new health-care overhaul law mandates prescription drug and medical device makers to report payout information to the government, noted The Journal. The U.S. Department of Health and Human Services will take the information, consolidate the data, and publicize it via the Internet; annual reporting must begin in 2013, said The Journal.

Johnson & Johnson, Eli Lilly & Co., Pfizer Inc., GlaxoSmithKline PLC, Merck & Co., and Cephalon Inc. are among the drug makers that have begun posting information, although some have been mandated under settlement terms of government probes, wrote The Journal.

 


Johnson & Johnson Hit with Federal Kickback Charges
Johnson & Johnson is facing charges that it paid kickbacks to Omnicare, one of the nation's largest nursing home chains, in order to push drugs like <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal and <"http://www.yourlawyer.com/topics/overview/levaquin">Levaquin at the chain's facilities. According to allegations contained in a complaint filed by the U.S. Attorneys office in Boston, from 1999 to 2004 Johnson & Johnson paid kickbacks to Omnicare in a variety of forms, including rebates, grants and educational funding.

The complaint charges that Johnson & Johnson was aware that Omnicare pharmacists made recommendations to physicians about what drugs should be prescribed to home residents. The complaint repeatedly mentions internal Johnson & Johnson e-mails and statements detailing the relationship with Omnicare. The government claims that those documents show that Johnson & Johnson came to see Omnicare pharmacists as an extension of its sales force.

According to the complaint, while Johnson & Johnson was allegedly paying kickbacks, Omnicare's annual purchases of Johnson & Johnson drugs nearly tripled to more than $280 million. For example:

*From September 2001 the market share of the antibiotic Levaquin’s increased to 66.4 percent from 19.2 percent at the end of 1998. At the same time, a similar antibiotic made by a different firm, Cipro, plunged to around 28 percent, from 80 percent.

*Use of Johnson & Johnson's antipsychotic Risperdal nearly tripled during the five-year-period it received payments from the drugmaker. Prosecutors claim Risperdal was used to control anxiety among patients with dementia and Alzheimer's disease, an off-label use of the drug. Drug makers are prohibited by law from promoting off-label uses.

Prosecutors allege that Johnson & Johnson's conduct caused false or fraudulent claims to be filed with Medicaid, the public health program for the poor and disabled.

As we reported previously, in November, Omnicare agreed to pay $98 million to settle charges related to the alleged Johnson & Johnson kickback scheme. As part of the settlement, Omnicare entered into a corporate integrity agreement with the Department of Health and Human Services.

The claims against Johnson & Johnson were initiated by whistleblowers who could receive a share of any money the government collects.

 


Risperdal Said to be Responsible for Breast Growth in Boys
<"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal has been linked to breast growth, and even lactation, in boys under 18 who take the powerful antipsychotic drug. The condition is known as gynecomastia (male breast growth), and is usually permanent. In most cases, boys with Risperdal-associated gynecomastia must undergo breast reduction surgery, and even mastectomy, to correct the condition.

Risperdal was originally approved by the Food & Drug Administration (FDA) in 1993 to treat schizophrenia in adults. Later, its approved uses were expanded to include bipolar disorder I in adults, as well as irritability associated with autistic disorders in children from 5 to 16 years of age. Then in August 2007, Risperdal was approved for treatment of schizophrenia in adolescents aged from 13 to 17, as well as the short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17. It is not approved as a treatment for Attention Deficit Disorder (ADHD) though it is often prescribed off-label to treat children with the condition.

Risperdal causes a release of prolactin from the pituitary gland. Prolactin is a hormone that stimulates breast development and lactation. Recently, a report aired on CBS News that discussed the problem of gynecomastia in boys taking Risperdal. The boys highlighted in the CBS News report were often being given Risperdal off-label to treat ADHD.

One child cited by CBS, only age four, began developing a breast on one side of his body after he began taking Risperdal. At that young age, his breast had even begun producing milk. The child has undergone mastectomies to correct the problem.

Another boy, now 19, who began developing breasts as a result of Risperdal when he was 14, still suffers psychological affects even though he underwent a double mastectomy.

It is not clear how often boys taking Risperdal suffer from male breast growth. According to CBS, the drug's maker, Janssen, found that in a clinical trial it conducted involving fewer than 2,000 children, 43 developed the abnormal breasts.

In 2008, Duke University psychiatrist P. Murali Doraiswamy told The Wall Street Journal that Risperdal had the strongest link with gynecomastia in children and adolescents of any of the newer antipsychotic drugs–accounting for 70% of the cases analyzed. He has also found that some girls taking Risperdal begin to lactate before they reach puberty. In 2006, Doraiswamy co-authored of a study on antipsychotics and prolactin with FDA scientist. He told the Journal that the changes in hormones linked to Risperdal could not be considered harmless.

The surgery - usually a mastectomy - boys undergo to correct gynecomastia is painful. And the psychological problems suffered by many of these Risperdal victims can be even more difficult. That is why many families of these boys have chosen to file lawsuits against Janssen. According to CBS News, such lawsuits claim Janssen marketed Risperdal for unapproved uses in children, and downplayed serious side effects. These lawsuits point out that breast growth wasn't even mentioned under the "Warnings" section of the Risperdal label, but was only listed under "Precautions." They also allege that the language regarding gynecomastia in the Risperdal label was worded in "obscure" terms.

 


Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials
A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit involving Risperdal and other atypical antipsychotic drugs. While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.

Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.

As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard's Massachusetts General Hospital.

According to a Boston Globe article published at the time, emails written between executives at Johnson & Johnson subsidiary Janssen Pharmaceuticals indicate Biederman had repeatedly proposed that the company help fund the center. One of the emails, written in 2002, stated that “the rationale of this center is to generate and disseminate data supporting the use of risperidone (Risperdal) in this patient population.” Another email mentions at least $700,000 in Johnson & Johnson payments to the center, the Globe said.

Biederman’s dealings with drug companies have been questioned before. According to The Wall Street Journal, an investigation by Sen. Charles Grassley (R-Iowa) found that from 2000 through 2007, Biederman received $1.6 million from Johnson & Johnson. However, only a fraction of that was reported to Harvard. Earlier this year, Biederman agreed to step down from a number of industry-funded clinical trials until Massachusetts General Hospital investigates that lack of disclosure.

Now The Wall Street Journal is reporting that a Powerpoint presentation given by Biederman to Johnson & Johnson executives included a slide that said a future clinical trial aimed at evaluating the use of Risperdal in preschool children “will support the safety and effectiveness of risperidone (Risperdal) in this age group."

Another slide that addressed a Risperdal trial meant to compare the drug to others in treating pediatric bipolar disorder promised the study would "clarify the competitive advantages of risperidone vs. other neuroleptics," the Journal said.

Meanwhile, the Boston Globe reported today that Biederman is trying to have his own testimony in the antipsychotic lawsuit sealed. According report, Biederman's lawyers have argued that making his testimony public “could be immensely damaging to him, both personally and professionally."

 


Misleading Risperdal, Duragesic Patch Claims Prompt Fines in West Virginia Lawsuit
<"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal maker Johnson & Johnson has been ordered by a West Virginia judge to pay a hefty fine over a 2003 letter to doctors that obfuscated the antipsychotic drug's diabetes risk. According to Bloomberg News, the same judge also assessed a smaller fine after finding that doctors were misled about the risks and benefits of the company's <"http://www.yourlawyer.com/topics/overview/duragesic_patch">Duragesic pain patch.

Risperdal is one of class of drugs called atypical antipsychotics. Other atypical antipsychotics include Eli Lilly's Zyprexa, and AstraZeneca's Seroquel. These drugs have long been linked to an increased risk of weight gain and diabetes. According to Bloomberg News, in 2003, the Food & Drug Administration (FDA) required the makers of antipsychotics to warn about this risk.

The State of West Virginia had brought suit against Johnson & Johnson and its Janssen unit over claims made in the 2003 letter to doctors, Bloomberg News said. The FDA had already cited the same letter for being misleading. West Virginia Circuit Court Judge Martin Gaughan agreed, writing that the letter was "deliberately constructed to circumvent the FDA's mandated warning for an increased risk of diabetes, and deliberately constructed to mislead health-care professionals."

According to Bloomberg News, the judge fined Johnson & Johnson $1.95 million for the letter and an additional $2 million for Risperdal sales calls made in West Virginia from November 2003 to July 2004.

The makers of antipsychotics have faced increasing scrutiny over the way these drugs are marketed. Hundreds of lawsuits have been filed by individuals who claim the drug's diabetes risks were hidden. Meanwhile, federal and state authorities have, like West Virginia, filed lawsuits over the drugs' illegal promotion.

Earlier this year, Eli Lilly agreed to pay $1.4 billion in fines to settle federal charges over its promotion of Zyprexa. Documents unsealed in Seroquel litigation indicate that, among other things, AstraZeneca directed sales reps to downplay the drug's diabetes risks.

In West Virginia, Judge Gaughan also assessed Johnson & Johnson and Janssen a $525,000 fine for distributing a brochure that contained misleading information about the Duragesic patch. According to a report on WOWKTV.com, the FDA had also warned the companies that the brochure was misleading.

In his order, Judge Gaughan wrote that "The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however . . . the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.”

Fentanyl patches, like the Duragesic Patch, have long been linked to accidental overdoses. In December 2007, FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

 


Atypical Antipsychotic Drugs Double Heart Risks
Atypical antipsychotic drugs, including <"http://www.yourlawyer.com/topics/overview/seroquel">Seroquel, Zyprexa and <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal, double the risk of heart failure and death, according to a new study published in The New England Journal of Medicine. According to Reuters.com, the new study raises questions about claims that atypical antipsychotics are safer than older generation antipsychotics.

Atypical antipsychotics, among the best-selling in the world, are used to treat schizophrenia and other mental problems. But according to Reuters, they are also widely used off-label to treat dementia and childhood hyperactivity. Many experts and patient advocates have called for a halt to such practices, and this study will likely add ammunition to their arguments.

For this latest study, researchers at the University of Vanderbilt studied nearly 277,000 people in Tennessee. About 46,000 were taking atypical antipsychotic drugs and 44,000 were taking typical antipsychotic drugs. About 187,000 weren't taking any of the drugs. Patients ranged in age from 30 to 74 years; the average age was about 46.

The study found that those taking the highest dose of the new antipsychotics had the greatest risk of heart failure and death, Reuters said. The danger faded once they stopped taking the drugs. The risk spanned all age groups, including younger people.

The drugs studied in this group included clozapine, made generically, Johnson & Johnson's Risperdal, Zyprexa, and Seroquel, made by AstraZeneca, Reuters said. The "typical" drugs used for comparison were haloperidol and thioridazine, both generics.

According to The Wall Street Journal, an editorial accompanying the study said the use of such drugs should be "reduced sharply" among children and elderly patients

Last week, we reported that another study conducted by scientists at the Wolfson Centre for Age-Related Diseases at King’s College London found that use of antipsychotic drugs to treat Alzheimer's disease patients doubled their chance of dying. While they are not approved for that use, antipsychotics are used in dementia patients, including those with Alzheimer's to control dementia. Researchers conducting the British study concluded that the risks of the drugs in these patients outweighed any potential benefits.

According to Reuters, in June the U.S. Food and Drug Administration (FDA) said older, conventional antipsychotic medications should carry a warning on the packaging about the risk of death. The FDA issued a similar warning in 2005 for newer antipsychotics. 


Alzheimer's Patients on Risperdal, Thorazine, Other Anti-Psychotic Drugs, More Likely to Die
Using anti-psychotic drugs, such as <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal and Thorazine, to treat Alzheimer's disease patients isn't worth the increased risk of death, a new study concludes. Such drugs are often used to stem aggression sometimes exhibited by Alzheimer's patients, but the new study conducted by British researchers found these medications could also double patients' chance of dying.

The research, conducted by scientists at the Wolfson Centre for Age-Related Diseases at King's College London, was published in today's issue of the journal Lancet. For the study, the researchers followed 165 British patients aged 67 to 100 years with moderate to severe Alzheimer's disease from 2001 to 2004. Half were being treated with anti-psychotic drugs, including Risperdal, Thorazine and Stelazine. The other half got placebos.

After a year, 39 patients of the 83 receiving anti-psychotic drugs had died. Of the 82 taking placebos, 27 were dead after a year. Only 46 percent of those taking anti-psychotic were still alive after two years, while 71 percent remained alive in the placebo group. After three years, the numbers of those living in the drug group dropped to 30 percent, while 59 percent of those in the placebo group were still living.

This is just the latest study to show a correlation between anti-psychotic drugs and a higher death rate in Alzheimer's patients. According to a report in the Associated Press, no one knows exactly why this association exists, but some surmise that they could be damaging to the brain. Another theory is that their sedative effects make patients less mobile, which can make them more vulnerable to infection, the Associated Press said.

According to the Associated Press, anti-psychotic drugs are routinely given to up to 60 percent of dementia patients living in nursing homes. They are used to control aggression, as well as the hallucinations they sometimes experience. But guidelines recommend that such medications be used "cautiously and temporarily", the Associated Press said. In addition to the increased risk of death, anti-psychotic drugs are linked to other side effects, including respiratory problems, stroke and diabetes.

Clive Ballard, lead author of the Lancet article, told the Associated Press that the risks associated with anti-psychotic drugs are not worth the benefits. "Would I want to take a drug that slightly reduced my aggression but doubled my risk of dying? I'm not sure I would," Ballard said. 


Risperdal Promotion Questioned in Lawsuit
A prominent Harvard psychiatrist may have promised that his work at a psychiatric research institute would promote the off-label pediatric use of <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal in a bid to convince Johnson & Johnson to fund the facility, The Boston Globe reported today. The revelations come from emails and other documents released in a lawsuit involving Risperdal and other atypical antipsychotics.

Risperdal wasn't approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected "opinion leaders" - usually top experts in their field - to discuss their off-label prescribing experiences at "educational" talks or meetings.

According to the Boston Globe, Harvard psychiatrist Dr. Joseph Biederman -one of the country's top experts on bipolar disorder in children - is one of those "opinion leaders". As we've reported previously, Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder.

Biederman's dealings with drug companies have been questioned before. According to The Wall Street Journal, an investigation by Sen. Charles Grassley (R-Iowa) found that from 2000 through 2007, Biederman received $1.6 million from Johnson & Johnson. However, only a fraction of that was reported to Harvard.

According to the Journal, Biederman and colleagues published many favorable Risperdal studies while he was on the Johnson & Johnson payroll. A 2005 study, for instance, concluded that "risperidone (Risperdal) treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder."

Now, documents released as part of a huge, multi-state lawsuit have raised questions about Biederman's role in convincing Johnson & Johnson's to fund a center on pediatric bipolar disorder at Massachusetts General. According to the Boston Globe, the lawsuit was brought on behalf of more than 2,000 patients, including children, who claim to have been injured by atypical antipsychotics, including Risperdal. Though Biederman is not a defendant in the suit, the Globe reports that plaintiffs lawyers are using his relationship with Johnson & Johnson to illustrate how researchers and drug companies conspired to boost off-label prescriptions of atypical antipsychotics.

According to the Globe article, emails written between executives at Johnson & Johnson subsidiary Janssen Pharmaceuticals indicate Biederman had repeatedly proposed that the company help fund the center. One of the emails, written in 2002, stated that "the rationale of this center is to generate and disseminate data supporting the use of risperidone (Risperdal) in this patient population." Another email mentions at least $700,000 in Johnson & Johnson payments to the center, the Globe said.

The Boston Globe also reports that the research institute's 2002 annual report states that one of the center's "essential features" is its ability to conduct research that "will move forward the commercial goals of J&J (Johnson & Johnson)"

Hopefully, Biederman himself will be able to shed more light on his dealings with Johnson & Johnson. According to the Globe, lawyers representing plaintiffs in the atypical antipsychotic lawsuit recently won their bid to compel an interview with Biederman. The Globe said he is expected to be interviewed under oath by January. 


Antipsychotics Do More Harm than Good In Dementia Patients
Antipsychotic drugs use to reduce symptoms of agitation, aggression, and violence in dementia patients is on the rise, as can be seen in soaring sales of antipsychotics like <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal,<"http://www.yourlawyer.com/topics/overview/seroquel"> Seroquel, and <"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa. These drugs experienced a $4 billion dollar increase in sales since 2000 for a total of $13.1 billion in 2007, due, in part, to an increase in such prescriptions in nursing homes. As a matter-of fact, researchers estimate that nearly 30 percent of all nursing home patients have received antipsychotic drugs at one time or another.

But, a 2006 study of Alzheimer’s patients revealed that in most, antipsychotics provided no significant improvement over placebos in treating aggression and delusions. A year earlier, the Food and Drug Administration (FDA) ordered newer antipsychotics be labeled with a “black box” label warning of an increased risk of death. Last week, the FDA required a similar warning on older antipsychotics, as well. First generation antipsychotics, like Haldol, carry a significant risk of repetitive movement disorders and sedation. Second-generation antipsychotics, called atypicals, are commonly prescribed because the risk of movement disorders is lower; however, they can cause sedation and can contribute to weight gain and diabetes; some experts cite a lack of research for these drugs used in behavioral problems. If patients begin showing behavioral symptoms of dementia, doctors said, they should have complete medical and psychiatric workups first, especially if symptoms develop suddenly.

The FDA has not approved marketing of antispychotics for older dementia patients; however, the drugs are routinely prescribed “off label.” Off-label prescribing is perfectly legal and left to the discretion of the prescribing physician; marketing of drugs for off-label, unapproved purposes is illegal and several states are suing big name antipsychotic drug makers on charges of false and misleading marketing.

Other, recent research revealed community-dwelling adults receiving a prescription for a newer antipsychotic medication were 3.2 times more likely than individuals who received no antipsychotic therapy to be hospitalized or to die during 30 days of follow-up. Those who received older antipsychotic therapy were 3.8 times more likely to have such an event compared to those who received no antipsychotic therapy. In nursing home groups, those taking older antipsychotics were 2.4 times more likely to be hospitalized or die, while those taking newer drugs were 1.9 times more likely to die or be hospitalized during the 30 day follow-up. Meanwhile, a recent British study concluded that the continuing use of antipsychotic drugs provides neither cognitive nor neuropsychiatric benefits when taken by Alzheimer’s patients.

Some nursing homes are trying a different approach, so-called environmental intervention, tactics that include reducing boredom, providing intellectual and physical stimulation, exercise, calming music, pet therapy, and improving how staff approaches and talks to dementia patients. Such approaches are time consuming, do not help all patients, can be prohibitively expensive, and are more difficult to provide as Alzheimer’s continues to increase. Also, nursing homes are understaffed and insurers do not typically reimburse for the type of one-on-one psychosocial therapy that advocates recommend. Despite dangerous side effects, sedatives and antipsychotics, are often prescribed because they offer a quick fix. 


Risperdal, Haldol and other Antipsychotic Drugs Little Help in Managing Aggression
Antipsychotic drugs used to manage aggressive outbursts in intellectually disabled people are no more effective than placebos for most patients and may be less so, researchers report, challenging established worldwide medical practice. Researchers focused on Janssen’s <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal and Haldol but said findings applied to similar medications such as Zyprexa. These drugs account for over $10 billion in annual sales and at least half of all prescriptions are for unapproved off label uses to treat aggression or irritation. While it is illegal for drug companies to market approved medications for off label uses, how a drug is used remains at the prescribing physician’s discretion; many use antipsychotics—developed for schizophrenia—as tranquilizers for children with attention-deficit problems, college students with depression, Alzheimer’s patients, and intellectually handicapped people.

The study tracked 86 adults—aged 18 to 65—with low IQs living in community housing in England, Wales, and Australia for more than a month and found a 79 percent reduction in aggressive behavior among those on placebos as compared to a 65 percent or less reduction in those on antipsychotics. Dr. Peter J. Tyrer, professor of psychiatry at Imperial College London, led the team. Patients were given Risperdal, Haldol, or a placebo and behavior was tracked—many with very low IQs tend to lash out at others and themselves quickly. Patients in all three groups improved; those on the placebo improved significantly compared to those on medication.

Researchers said the results would likely spur requests for government review of British treatment standards. Others feel these findings will add to the continuing debate over the widening use of antipsychotic drugs and patient advocates and some psychiatrists feel the medications are overused. While studies have been mixed, the drugs do have serious side effects and doctors have little to guide them. Johnny L. Matson, a professor of psychology at Louisiana State University in Baton Rouge, co-author of an editorial with the study in the journal Lancet said, “The message to doctors should be, think twice about prescribing or just don’t do it. We know that behavioral treatments can work very well with many patients.” Others disagreed, saying the study did not reflect previous research or their experience. Janssen, a Johnson & Johnson subsidiary, said Risperdal only promotes approved uses, which in Great Britain, includes treating autism-related irritability. Tyrer said there was no reason to believe other antipsychotics used for aggression, like Zyprexa from Eli Lilly or Seroquel from AstraZeneca, would be more effective. “These people tend to get so little company normally, they’re neglected, they tend to be pushed into the background and this extra attention has a much bigger effect on them that it would on a person of more normal intelligence level,” said Tyler.

Study authors included researchers from the University of Wales and the University of Birmingham in Britain and the University of Queensland in Brisbane, Australia. Authors claim results “should not be interpreted as an indication that antipsychotic drugs have no place in the treatment of some aspects of behavior disturbance,” but the routine prescription of drugs for aggression “should no longer be regarded as a satisfactory form of care.” 


Abuse of Risperdal, Seroquel, Other Antipsychotic Drugs in Nursing Homes Widespread
Use of antipsychotic drugs like <"http://www.yourlawyer.com/topics/overview/Risperdal">Risperdal and <"http://www.yourlawyer.com/topics/overview/seroquel">Seroquel to control dementia patients has risen in recent years, despite the Food and Drug Administration's (FDA) "black box" warning labels that these drugs can increase the risk of death for elderly dementia sufferers. About 30% of nursing home residents are on antipsychotic drugs, according to the Centers for Medicare & Medicaid Services (CMS), most of them on newer, atypical antipsychotics. Federal law strongly discourages nursing homes from physically restraining unruly patients, but federal health-care programs such as Medicaid pay for drugs that may help calm aggressive behavior and agitation associated with Alzheimer's.

In 2005, Medicaid spent $5.4 billion on atypical antipsychotic medicines—more than it spent on any other drug class, including antibiotics, AIDS drugs, or high blood pressure. Atypical antipsychotics are approved for schizophrenia and bipolar disorder, but in what is known as "off label" use—use not approved by the FDA for FDA-approved medications—doctors often prescribe the drugs to dementia patients. The widespread use of antipsychotics among the elderly has begun to draw criticism from regulators, researchers, lawmakers, and the nursing-home industry. Senator Charles Grassley, the ranking Republican on the Senate Finance Committee, asked several drug manufacturers for records on how they may have marketed these drugs for use in geriatric patients and also has asked the Inspector General of the Department of Health and Human Services to investigate use of the drugs in nursing homes.

The $122 billion nursing-home industry has moved toward large, often understaffed, institutions where use of psychotropic drugs is rising. According to CMS, nearly 21% of nursing-home patients who don't have a psychosis diagnosis are on antipsychotics. A 2005 study found antipsychotics were prescribed not only for psychosis, but for depression, confusion, memory loss, and feelings of isolation. Last year, CMS instituted new guidelines to limit the use of antipsychotics; however, it's still easier for nursing homes to get reimbursed for giving patients extra pills than it is for hiring extra staff.

An Alzheimer's patient often cannot refuse antipsychotic drugs, says Cynthia Rudder, of the Long-Term Care Community Coalition. "You are basically quieting them against their will and it is absolutely horrendous," she says. Family members can object to the use of such drugs, but risk having their relative discharged for unruly behavior.

At CMS, officials stress the need to shift to smaller, less-rigid facilities as a way to reduce antipsychotic usage. Some nursing-home-industry officials agree change is needed, yet replacing drugs with approaches that require a more human touch is easier said than done.

There are some Alzheimer's patients for whom nonpharmacological approaches simply don't work, says William Thies, a vice president at the Alzheimer's Association in Chicago, and in these cases antipsychotics may be warranted. But the drugs need to be used very carefully, at the lowest dose and after ruling out a medical problem, says Thies, who has a doctorate in pharmacology.

A spokesman for AstraZeneca Pharmaceuticals LP, maker of Seroquel, says "decisions about medical treatment are made by physicians" and the company doesn't recommend the drug "for uses other than its approved indications in schizophrenia and bipolar disorder."

But according to the Wall Street Journal, some pharmaceutical companies have attracted scrutiny for marketing drugs for unapproved uses. It is illegal for drug makers to promote off-label uses, but doctors may prescribe medications as they see fit. Last month, the Arkansas attorney general filed suit against Johnson & Johnson and two of its units, claiming, among other things, that they "engaged in a false and misleading campaign" to promote its antipsychotic drug Risperdal to geriatric patients. 


 

Sitemap