Off-Label Antipsychotic Use Exposes Patients to Bad Side Effects: Study

The potential side effects of atypical antipsychotics may do more harm than good when used off-label, according to the findings of a new study. 

U.S. researchers found that while the off-label use of drugs like Seroquel and Risperdal have doubled in recent years, there are clear signs that there is a danger to using antipsychotics as a cure-all for psychiatric disorders instead of adhering to the uses they have been specifically approved by the FDA.

When used to treat unapproved uses like dementia, addictions, eating disorders and some personality disorders, antipsychotic side effects may result in weight gain, urinary problems and even death, which outweigh the potential benefits provided for the patients, according to the new research published in the Journal of the American Medical Association.

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Researchers looked at more than 150 efficacy trials from six different databases and evaluated what happened when a variety of antipsychotics were used to treat dementia, obsessive-compulsive disorder, anxiety and other problems. While they found that some of the drugs did help alleviate symptoms of the conditions, they also found an increased risks of death, stroke, urinary tract symptoms, weight gain, fatigue, sedation, akathisia and extrapyramidal symptoms.

The FDA and other agencies have warned particularly about attempts to use atypical antipsychotics to treat dementia, because the medications may increase the risk of death and the drugs do very little to actually treat dementia. Researchers in this latest study found a small, but statistically significant effect from the use of the drugs on dementia patients, but adverse events were common.

Many critics have argued that the wide “off-label” prescriptions for nursing home dementia patients is really a form a “chemical restraint” for hard-to-manage residents, which is widely regarded as a form of nursing home abuse.

In May, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) issued a report on atypical antipsychotic misuse in nursing homes that found off-label and dangerous use of the drugs was widespread.

The HHS-OIG report took data collected by the U.S. Centers for Medicare and Medicaid Services (CMS) in the first half of 2007 and found that 14% of the nation’s 2.1 million elderly nursing home residents were prescribed atypical antipsychotics at least once. Medical records indicate that 83% of those drugs were given for “off-label” reasons which were not approved by the FDA. About 88% of the off-label uses were for conditions that the FDA cautioned against in black box warnings, the strongest label advisory the agency can give. The FDA warnings date back to 2005.


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