FDA Investigating Reports of Side Effects to Drug Halcion
WASHINGTON (AP) _ The Food and Drug Administration says it is investigating an unusually high number of reports of unwanted side effects to the drug Halcion, the most widely prescribed sleep medication in the world.
An FDA advisory committee will review the drug at a meeting Friday to determine why the agency is receiving more reports of adverse reactions to Halcion than for other drugs in its class of hypnotics.
Halcion has been on the market since the beginning of 1983 and is The Upjohn Co.’s second largest sales item.
Spokeswomen for the company and the FDA said they did not know the nature of the reports about adverse reactions or the number of reports received. However, the FDA said that at the time the drug was approved it was aware of a variety of adverse effects reported in association with use of Halcion, including confusion, agitation, hallucinations, amnesia and bizarre behavior. All except bizarre behavior were included in label warnings, the FDA said.
Upjohn spokeswoman Florence Steinberg, said the company will review epidemiological data at the meeting that ″indicate that side effects with Halcion are not different in number or kind when compared with other medications in its class.″
She said the higher number of reports of problems associated with the drug stem in part from ″sensational allegations in the media about Halcion,″ including a case in which a Utah woman who was using the drug killed her mother. Murder charges against the woman were dismissed.
Steinberg said it was never established that Halcion caused the woman to act as she did and contends the woman was taking a number of medications at the time.
Analysts quoted in Wednesday editions of The Wall Street Journal said Upjohn has been seeing a slide in Halcion sales apparently because of reports of adverse reactions to the drug. The newspaper quoted analysts as estimating that Upjohn’s worldwide sales of Halcion were expected to fall from about $260 million in 1988 to about $235 million this year.