FDA Panel Backs Continued Use of Halcion : Drug: But committee urges stronger warning labels about possible psychological side effects from controversial sleeping pill.


A government advisory committee voted, 7 to 1, Monday to recommend continued use of the controversial sleeping drug Halcion but urged stronger warning labels about dosage and possible side effects, such as anxiety and impaired memory.

The Food and Drug Administration, which impaneled the committee of physicians and professors after Great Britain banned the drug last fall, is expected to follow the recommendations.

The drug, approved by the FDA in 1982, is the most widely prescribed in the world but has been under increasing scrutiny in the medical community following the British ban and restrictions slapped on its use in France, Spain and Germany.

Halcion also has been in the news because both President Bush and Secretary of State James A. Baker III have taken it while traveling. Despite White House statements to the contrary, Bush still takes the drug, his personal physician said recently.


“It’s been reported that I stopped the Halcion. I didn’t,” presidential physician Burton Lee III told The Times in an interview April 29. Halcion has been used by Bush as an occasional sleeping aid, often to help him fight the effects of jet lag on long trips.

White House Press Secretary Marlin Fitzwater said in February that Bush had stopped taking the drug because of the controversy over its side effects.

With some qualifications, the FDA advisory committee termed the drug both effective and safe after FDA officials presented an extensive re-evaluation of previous studies and officials of Upjohn Co., manufacturer of the drug, claimed that Halcion was as safe as, and more effective than, similar remedies for insomnia.

At the same time, Upjohn disclosed at a 10-hour meeting of the committee that it is working with the FDA to launch a new study of 10,000 patients to determine whether there are more serious side effects than indicated by dozens of previous studies.


“We want to put the issue (of Halcion’s safety) to rest,” Dr. Lawrence S. Olanoff, an Upjohn vice president, told the panel.

After the British ban last October, the FDA got Upjohn to insert a leaflet in the Halcion box that suggested restricting use to seven to 10 days and in lower doses than originally indicated.

The label warns that drowsiness and dizziness are common side effects but there are “special concerns,” such as memory problems and daytime anxiety or nervousness.

The current label also says that “a variety of abnormal thinking and behavior changes have been reported to occur,” such as “aggressiveness, confusion, bizarre behavior, agitation, hallucinations, depersonalization and worsening of depression, including suicidal thinking.”

The only negative vote was cast by Linda Frances Hezel, a nursing professor at the University of Missouri, who left the meeting early without providing an explanation. The committee heard from several doctors who urged that Halcion be taken off the market.

In a related matter, FDA Commissioner David A. Kessler said that his agency is continuing to investigate whether Upjohn had given the FDA fraudulent or misleading data in submitting Halcion for approval and continued use over the last 15 years.

The FDA announced in February that Upjohn had submitted “pivotal studies” done by a clinical investigator, Dr. William Franklin, who had been disqualified by the agency before the drug’s approval in 1982.



Halcion, the trade name for the drug triazoloam, was introduced in Belgium 15 years ago. The drug is available only by prescription and was approved for use in the U.S. market in 1982. In 1991, it accounted for $104 million in U.S. sales and $133 million abroad. Reports of an error in Upjohn’s safety data triggered a review of the drug last year. In October, British health officials pulled Halcion off the market, followed by Finland, Norway, Argentina, Jamaica and Lebanon. Canada, France and the European Community have restricted its use.