UPDATE 2-U.S. FDA expands antipsychotic drug warning
(Adds details about studies, quote from director of FDA's psychiatry drugs division)
WASHINGTON, June 16 (Reuters) - Older, conventional antipsychotic medications should carry a "black box" warning about an increased risk of death in some elderly people being treated for dementia-related psychosis, the U.S. Food and Drug Administration said on Monday.
The older drugs include Pfizer Inc's (PFE.N) Navane, Johnson & Johnson's (JNJ.N) Haldol, and Endo Pharmaceutical Holdings Inc's (ENDP.O) Moban, according to a database on the FDA's website.
It was not immediately clear which drugs were still on the market, and representatives for most companies could not be reached for comment. An FDA spokeswoman also could not say which ones were still sold.
Some antipsychotic drugs, such as GlaxoSmithKline Plc's (GSK.L) (GSK.N) Thorazine and Compazine, have been discontinued, according to the company and the FDA.
Other antipsychotic drugs include Loxitane, Mellaril, Orap, Prolixin, Stelazine, and Trilafon, but it was unclear which, if any, companies still make them. Some have been discontinued according to the FDA's online database.
FDA officials issued a similar warning for newer antipsychotic drugs in 2005. Those drugs, which include Bristol-Myers Squibb Co's (BMY.N) and Otsuka Pharmaceutical Group's Abilify and Eli Lilly and Co's (LLY.N) Zyprexa among others, already carry a boxed warning about such risk.
"The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis," the FDA said in a statement.
Pfizer spokeswoman Shreya Jani said the company would comply with the FDA's request for the boxed warning. Other drugmakers did not return calls seeking comment.
Neither the older or newer medications are approved to treat forgetfulness and other symptoms of dementia, the FDA said. But while such use is not approved by the agency, doctors are allowed by law to prescribe medications as they see fit.
Most antipsychotic drugs are aimed at treating symptoms of schizophrenia, a brain disorder that can trigger unusual thoughts and behavior as well as speech trouble and memory problems.
The older anti-psychotic drugs received the warning after two observational studies indicated the drugs also had an increased risk of death associated with them when used to treat elderly patients with dementia.
Dr. Thomas Laughren, the director of the FDA's division of psychiatry drugs, told reporters the older, anti-psychotic drugs are only now receiving the black box warning because previously there had not been enough data.
In the studies, researchers found patients taking the older drugs had a 4.5 percent risk of dying, compared with patients on a placebo whose risk was 2.6 percent, Laughren said. He noted, however, that the patients in the study were elderly and many of them were already very ill, possibly resulting in biased findings.
The elderly patient warning, Laughren said, applies to those age 65 and older.
"We aren't telling clinicians they can't use (the atypical medications)," Laughren said. (Reporting by Susan Heavey and Georgina Coolidge)
