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.

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