Task Force Recommends Justice Department Review of Halcion's® Manufacturer, Upjohn

EXECUTIVE DRUG CONTROL SUMMER 1996

A Government task force, set up by the FDA in 1994, in a May 31 report advised the Justice Department to assess whether Pharmacia & Upjohn Inc., the makers of the sleeping pill Halcion®, failed to report serious side effects of the drug as required by law (Kurt Eichenwald, "A Justice Dept. Review Is Sought On a Sleeping Pill's Side Effects," New York Times, June 1, 1996, p. 8).

Upjohn said that it tries to present accurate information to the FDA, but that "mistakes were made in the past." FDA officials pointed out that the task force had not made a criminal referral, but suggested Federal prosecutors determine for themselves whether an investigation is needed.

Controversy has surrounded Halcion®, the brand name for triazolam, since it was approved in 1982. The FDA has examined the drug repeatedly and added label changes to warn of side effects such as anxiety, abnormal thinking and behavior changes. Other countries have banned the drug due to these side effects. Britain banned the drug in 1991, stating that Upjohn had hidden safety problems that might have blocked Halcion's® original approval. Halcion® was one of Upjohn's best-selling drugs, but annual sales have slumped 60% after it lost patent protection and questions of safety emerged.

The task force advised that Halcion® could stay on the market because it appeared to be safe if its users follow label instructions and are aware of possible side effects. But the report added that because of unresolved questions concerning Halcion®, further assessments of the drug's safety and efficacy might be needed. Upjohn said it would continue to cooperate with all investigations and that "another assessment of it will confirm what the agency and its advisory committees have concluded for years: Halcion® is safe and effective when used as recommended."