Some drugs risky for seniors, FDA says

WASHINGTON — The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death.

Antipsychotic drugs are approved to treat schizophrenia and bipolar disease, but doctors frequently prescribe them to treat elderly patients with dementia.

The FDA's announcement was an update to a 2005 action, when regulators added warnings about increased heart attacks and pneumonia to drugs called atypical antipsychotics. The medicines include blockbusters like Eli Lilly's Zyprexa and Johnson & Johnson's Risperdal.

FDA said Monday those same risks apply to 11 older drugs known as typical antipsychotics, including Pfizer's Navane and Endo Pharmaceutical's Moban. The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are believed to have fewer side effects, such as tremors.

Under FDA's orders, both drug types will now carry boxed warnings — the most serious a drug can carry — describing their risks.

Federal officials have repeatedly urged doctors not to medicate seniors unnecessarily. Despite such warnings, health professionals continue to prescribe psychiatric drugs "off-label," or for uses that have not been approved by the FDA. About 20 percent of seniors in nursing homes who receive antipsychotics have not been diagnosed with psychiatric problems, according to data released by Medicare.

Also

U.S. regulators said that Amgen's anti-inflammatory medication Enbrel causes "life-threatening" side effects in children with psoriasis. The report cast doubt about whether the drug, which is used to treat adults with the skin disorder and for children and adults with rheumatoid arthritis, can win expanded approval.

Information from Bloomberg News is included in this report.