UK extends its ban on Halcion sleep drug
The decision follows an appeal by the Upjohn Company, which makes the drug, before the UK Medicines Commission in May. A rapid decision on the drug's fate had been expected.
However, Upjohn received a letter informing it of the continued suspension of the drug's licence (effective from 2 July) only last week. A final decision would be made in the near future, according to the letter, signed by Dr Keith Jones, head of the Medicines Control Agency.
The agency is thought to be reserving its final decision until the European Committee for Proprietary Medicinal Products reports on its review of short-acting sleeping drugs and sedatives, such as Halcion, according to Scrip, the pharmaceutical industry newsletter. Alternatively, the UK authorities may be re-assessing all the clinical data on the drug. The Department of Health declined to comment on the MCA decision.
Halcion has been linked with amnesia, paranoia, aggression and other psychiatric disturbances. Hundreds of people here and in the United States are seeking damages because of claimed side- effects.
Halcion was withdrawn in October 1991 after data from a clinical trial was resubmitted to the Committee on Safety of Medicines, the Government's drug safety watchdog. The data had been missing from a summary presented to the CSM as part of Upjohn's original UK licence application.
An appeal to the CSM in December 1991 was rejected. In May the American Food and Drug Administration decided Halcion could continue to be prescribed but recommended that warning labels be strengthened.
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