FDA Calls for Warning on Antipsychotic Drugs

The U.S. Food and Drug Administration on Monday ordered new warnings on antipsychotic drugs, alerting physicians to a higher death rate when the medicines are prescribed for atypical use of treating dementia in elderly patients.

The black box warning affects Eli Lilly and Co.’s Zyprexa and Symbyax, AstraZeneca Pharmaceuticals LP’s Seroquel, Johnson & Johnson’s Risperdal, Novartis AG’s Clozaril, Pfizer Inc.’s Geodon, and Bristol-Myers Squibb Co.’s and Otsuka America Pharmaceutical’s Abilify.The FDA said it is asking the companies to add the boxed warning to their labels describing the heightened risk and noting the drugs are not approved to treat symptoms of dementia in the elderly.The FDA said after reviewing 17 studies of four drugs in the class, the death rate for elderly patients on the medication were 1.6 to 1.7 times greater than those on a placebo. Most of the deaths were either heart related or from infections, the FDA said.Because the FDA believes it is a class effect, it is ordering the warnings on all drugs in the category, it said.Eli Lilly spokeswoman Carole Copeland said the Zyprexa label has carried a warning with data on increased mortality risk in elderly dementia patients since May of last year — although not in a so-called black box — and the company had notified physicians of the risk since January 2004.Bristol-Myers said Abilify has carried warning for use in elderly dementia patients on its label since February.Doug Arbesfeld, a spokesman for J&J’s Janssen Pharmaceutica unit, said the company would work closely with the FDA on its Risperdal label. He added it has been looking into increased risk, including stroke risk, in the same patient population for some time.AstraZeneca, makers of Seroquel, said it was reviewing the FDA letter, which the companies involved said they just received.Stock reaction was mild because all in the class were asked to add the warning, analysts said. Elderly patients with dementia are a relatively small subgroup of patients taking the drugs.These types of “safety issues have been ubiquitous to the class,” said Barbara Ryan, an analyst at Deutsche Bank.The FDA is under increased scrutiny over its handling of drug safety amid market withdrawal of several big drugs and as an agency whistle-blower contends drug companies influenced FDA policy.”The FDA is moving toward increasing awareness of various side effects by updating labels more aggressively,” Ryan said.(Source: Reuters Health: April 2005.)