Halcion Sleeping Pill Banned by Britain; Risks Seen
The British government on Wednesday banned the drug Halcion, the world’s most widely prescribed sleeping pill.
Halcion, and other medicines containing triazolam, have been associated with psychological side effects, particularly memory loss and depression, an announcement from the Department of Health said.
“It is now considered that the risks of treatment with triazolam outweigh the benefits,” the agency said in a statement, which added:
“Patients who are currently using triazolam should consult their doctor before stopping their treatment, as sudden withdrawal of the medicine can lead to withdrawal symptoms such as insomnia and anxiety.”
The drug, used by up to 800,000 people in Britain and by a reported 7 million consumers in the United States, is manufactured by Upjohn Co., a pharmaceutical firm based in Kalamazoo, Mich.
Upjohn Chairman Theodore Cooper declared Wednesday of the drug, first manufactured in 1977 and registered in more than 90 countries: “There is absolutely no scientific or medical evidence that warrants withdrawal of Halcion tablets in the United Kingdom or any other country.”
In Washington, Dr. David A. Kessler, commissioner of the Food and Drug Administration--the agency that regulates drugs in the United States--said that FDA officials intend to seek further details from British health officials.
“We are meeting with the British to more fully understand the basis of their actions,” Kessler said in an interview. “As a regulatory agency, we take very seriously any reports questioning the safety or efficacy of drugs that have been approved in the United States, and we will look into the issue thoroughly.”
But Dr. Carl Peck, director of the FDA’s center for drug evaluation and research, said the FDA has “no basis at the moment for any action.”
“We have an approved drug on the market that was approved on the basis of data submitted to us that demonstrated its effectiveness and safety,” he said. The British, he added, “have not shared with us any data or precise information about the basis of their decision.”
Peck advised any patients taking the drug to “continue to take whatever drugs their physicians have prescribed, and if they have any concerns, they should contact their physicians.”
Upjohn said the British Committee on Safety of Medicines gave it the chance to remove Halcion voluntarily before the suspension but that it had refused.
Upjohn for years has denied that its highly profitable sleeping pill--whose name comes from a Greek word for peace and calm--has side effects, despite a ban on it by the Netherlands in 1979 and demands for smaller-dose pills in France and Italy.
The drug was approved for marketing in the United States in December, 1982.
FDA officials said they have been studying reports of adverse reactions to the drug for several years. In 1987, based on these reports, the FDA reduced the recommended dosage.
In September, 1989, the agency asked an outside advisory committee of pharmacologic experts to review the data and make recommendations based on their findings.
Such committees typically review studies and other data for the FDA, and advise the agency on what action to take either in approving experimental drugs for sales, or in regulating drugs that are already on the market.
The committee found no reason to further reduce the recommended dosage, or remove the drug from the market. But it proposed that the agency include a warning to patients that the drug has the potential to cause amnesia.
Earlier this year, an American woman won an out-of-court settlement in a multimillion-dollar lawsuit when she claimed that she killed her mother in 1988 under the influence of Halcion. Ilo Grundberg said she had no clear motive or memory in the killing of her 83-year-old mother and pleaded that she was involuntarily intoxicated. The murder charges were dismissed.
British regulators said they re-examined the issue after Upjohn recently discovered transcription errors related to a single clinical trial with Halcion in 1972 in the United States. Upjohn said that it had re-analyzed data from that trial and the other 86 trials which had supported the initial registration of the sleeping pill.
But Upjohn’s Cooper declared in the statement: “Our re-analysis in no way changes the overall risk-benefit profile of the product.”
He said that the British authorities have given the company until Nov. 8 to file an appeal on Wednesday’s adverse ruling.
In Washington, Peck said he is scheduled to meet tonight with his British counterpart, Dr. Keith Jones, director of the British medicines control agency, in a session that was arranged earlier. But, as a result of Wednesday’s action, “Halcion will definitely be on the agenda,” he said.
Peck added: “We need to ascertain if they have new data, or a new analysis of old data. We need to know why they came to the conclusion that, for the British, the drug is not safe enough.”
Tuohy reported from London and Cimons from Washington.