Stronger written warnings and new packaging are being provided for the prescription sleeping medication Halcion (triazolam) because of concern about the drug's side effects.
The Upjohn Company of Kalamazoo, Mich., agreed last November to make the changes in response to a request by FDA. The British Conunittee on Safety of Medicines suspended marketing of the drug in the United Kingdom in October 1991, saying that Halcion had a higher frequency of psychiatric side effects than other sleep-aid drugs, including memory loss and depression.
Halcion has been prescribed in more than 90 countries since its introduction in Belgium in 1977. It went on the market in this country in 1983.
The changes made by the Upjohn company include:
* revised physician labeling emphasizing appropriate use in treating insomnia and information about side effects and dosage
* a patient package insert that includes explicit information about the risks and benefits of Halcion
* "unit-of-use" packaging containing 10 tablets per package to help physicians more closely monitor patients' use of the drug.
Because there have been more adverse behavioral side effects reported for Halcion than for other sedative hypnotic drugs, FDA in September 1989 asked a committee of outside experts to examine the data for the drug. The committee concluded that the reports alone were not necessarily evidence of excess risk, since they could represent the larger number of prescriptions being written for Halcion or differences in reporting practices. Therefore, the committee recommended only that the labeling for Halcion be modified to state that the drug has a greater potential than some other similar drugs to induce temporary amnesia.
FDA plans to ask manufacturers of four similar sleep aids on the market to revise the labeling for their products, prepare patient package inserts, and develop unit-of-use packaging. The agency is also reviewing the data submitted in the original marketing application for Halcion and is investigating a dosing study of Halcion in prisoners in which safety data were reported inaccurately.
Relief for Hangovers, Gluttony
Consumers and others have until April 22 to comment on an FDA-proposed regulation for nonpresctiption products to treat hangovers and stomach upsets. The proposal, published in the Dec. 24, 1991, issue of the Federal Register, sets conditions under which such products would be classified as safe and effective.
If the rule is made final, the products will be considered safe and effective if they contain the following active ingredients and list them on their labels:
* for upset stomach: antacids, certain internal analgesic-antacid combinations, and products containing bismuth subsalicylate
* for hangover symptoms: antacid-internal analgesics and stimulant-internal analgesic combinations such as caffeine and aspirin or caffeine and acetaminophen.
Acetaminophen, aspirin and antacids are safe and effective for both upset stomach and hangover products, according to the proposal.
FDA's proposal states that some products, such as those that contain both an antacid and caffeine, are not safe and effective for hangovers because the ingredients counteract each other.
Hangover products containing activated charcoal have not been studied enough to determine their effectiveness, FDA said. If the rule is finalized, manufacturers will have to remove hangover relief claims from these products' labels until more data are submitted to FDA.
FDA previously reviewed products to prevent alcohol inebriation and found none to be safe and effective. No such products are on the market.
Review of these products was part of an ongoing comprehensive review of nonprescription drug products.
In addition to the April 22 public comment deadline, manufacturers and others have one year to submit new data. If new data are submitted, there will be an additional two months for public comment. Comments should be sent to: Dockets Management Branch (HFA-305), FDA, Room 1-23, 12420 Parklawn Drive, Rockville, Md. 20857.
COPYRIGHT 1992 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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