Dangers of Off-Label Antipsychotic Use - Consumer Justice Foundation

Dangers of Off-Label Antipsychotic Use

Written by Faith Anderson on October 7, 2011
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Benefits of Off-Label Antipsychotic Use Outweighed by Risks

In the JAMA study, researchers examined more than 150 efficacy trials from six different databases, and evaluated the results of antipsychotic drugs used to treat obsessive-compulsive disorder, dementia, anxiety and other problems. Although some of the medications were effective in relieving the symptoms of the conditions, researchers also found an increased risk of a wide range of side effects, including death, stroke, fatigue, weight gain, urinary tract symptoms, sedation, akathisia, and extrapyramidal symptoms.

Use of Antipsychotics to Treat Dementia in Elderly

The FDA and other agencies have issued warnings concerning attempts to use antipsychotics as a treatment for dementia, because the drugs may increase the risk of death without any evidence of effectively treating dementia. Researchers involved in this new study found a small, but statistically significant effect from the use of antipsychotic drugs on dementia patients, but adverse events were common. Many critics have argued that the wide off-label prescription of antipsyhotic drugs to treat dementia patients in nursing homes is really a form of “chemical restraint” for residents that are difficult to manage. This inappropriate use of medication is widely regarded as a form of nursing home abuse.

Use of Antipsychotics in Nursing Homes Unwarranted and Dangerous

In May, the U.S. Department of Health and Human Services’ Office of Inspector General issued a report indicating that off-label and dangerous use of antipsychotic drugs in nursing homes was widespread. This report took data collected by the U.S. Centers for Medicare and Medicaid Services in the first half of 2007, and found that 14% of America’s 2.1 million nursing home residents were prescribed atypical antipsychotics at least once. According to medical records, 83% of these drugs were prescribed for off-label uses which were not approved by the FDA. Approximately 88% of the off-label uses were for conditions that the FDA actually warned against in black box warnings, which is the strongest warning the agency can issue, dating as far back as 2005.

Posted Under: FDA - Food and Drug Administration
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