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More Antipsychotic Drugs Get Stronger Warning Labels

The US Food and Drug Administration (FDA) announced today that some “conventional” antipsychotic prescription drugs must now carry a black box warning label just like the one that has come on newer antipsychotic drug labels since an FDA order in 2005. The black box message is that the drugs increase the risk of death for elderly patients suffering from dementia.

Considered conventional because they’ve been on the market for many years, prolixin and thorazine are two commonly prescribed drugs that now require the stronger black box warning label. Risperdal and Zyprexa are two newer drugs, called atypical antipsychotics, that have carried the warning since 2005.

Various studies, reviewed in 2005, led researchers at the FDA’s Center for Drug Evaluation and Research Division of Psychiatry Products to the conclusion that the newer, atypical antipsychotic drugs, which were under study at that time, increased the likelihood of death in elderly individuals who took them. During a 10-week study period, almost 4.5% of the study participants taking the antipsychotic medications died while only 2.6% of the control group, taking placebos, died during the course of the study. Patient cases under review involved very ill nursing home residents in their 80s. In most cases, cause of death was cancer, pneumonia, or similar infection.

Observational analysis since 2005 has led the FDA to issue Monday’s order for stronger labeling for the older, conventional antipsychotics, too. Neither the older antipsychotic medications nor the newer, atypical antipsychotics have gotten FDA approval for treatment in elderly patients with dementia.

Nevertheless, antipsychotic medications are sometimes prescribed to quell the psychotic and behavioral symptoms of dementia, especially in patients prone to aggression or agitation which might lead to violence.

All antipsychotic medications block the brain’s receptors for dopamine. The most significant difference between the older and the newer ones is the side effects associated with them.

Source: FDA

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