WASHINGTON — The world's most-prescribed sleeping pill can cause temporary memory loss but, because there is no evidence that it endangers public health, it should not be banned, a federal advisory panel said Friday.
The Food and Drug Administration's advisory committee unanimously recommended that the agency change the label on Upjohn Co.'s sleeping pill--called Halcion--to warn doctors that the drug may be more likely to cause amnesia than similar medications.
In the last year, cases of violent behavior and death allegedly linked to Halcion have received considerable publicity. Upjohn contends that such attention has contributed to an increased number of reports of Halcion-linked side effects to the FDA.
Dr. Daniel Casey, chairman of the FDA advisory committee, said amnesia was the only potential problem with Halcion that stood out in data presented Friday by Upjohn and the FDA.
"Given the limited amount of information we had, we did not sense there was a substantial problem with other types of side effects," said Casey, chief of psychiatric research at the Veterans Administration Medical Center in Portland, Ore.
The FDA said that 45 times more cases of temporary memory loss associated with Halcion were reported to the agency than for a similar drug, Sandoz's Restoril, between 1983 and 1988. That figure was adjusted for Halcion's larger market share.