Britain Rejects Diabetes Pill Rezulin’s Return

British health authorities have rejected a drug company’s proposal to resume selling the controversial diabetes pill Rezulin in the United Kingdom, it was announced Monday.

The Medicines Control Agency rejected the application by Glaxo Wellcome, which holds the license to market the drug in Britain and elsewhere in Europe. The agency is Britain’s counterpart to the U.S. Food and Drug Administration.

Glaxo, acting in consultation with the agency, had withdrawn Rezulin voluntarily from the British market in December 1997 after liver-failure deaths were reported among patients in the United States and Japan.

An FDA advisory committee is scheduled to meet Friday to reconsider Rezulin’s status in the United States. After approving the diabetes pill in January 1997, the FDA has continued to permit Rezulin’s use.

Both the FDA and the manufacturer of Rezulin, the New Jersey-based Warner-Lambert Co., have said that the drug is safe when used in concert with regular liver-function monitoring.

Rezulin has generated sales exceeding $1 billion for Warner-Lambert since the drug went on the U.S. market in March 1997. The drug has remained off the British market after an aborted three-month launch in the fall of 1997.

In a prepared statement, Glaxo said Monday that it submitted “a comprehensive package” seven months ago to the Medicines Control Agency to persuade it to allow sales of Rezulin to resume in Britain.

“The MCA stated that, despite the [safety] conditions proposed, the data and arguments submitted did not give assurance that the balance of risk and benefits of [Rezulin] could be made favourable,” Glaxo said in the statement.

Warner-Lambert originally promoted Rezulin as a once-a-day pill that would allow some adult-onset “Type 2” diabetics to halt insulin injections. In addition to diet and exercise, Rezulin is one of 10 or more medications available to help control blood-sugar levels for patients with adult-onset diabetes. There are an estimated 15 million people in the United States with adult-onset diabetes.

Based on reports filed voluntarily by doctors and other health professionals, the FDA as of last month had identified 100 liver-related deaths among Rezulin patients. The FDA, without explaining its methodology, recently told a member of Congress that it had found 33 of those deaths to be “associated” with the drug.

The Times disclosed last week that doctors and others have reported 155 deaths in which Rezulin was cited as a suspect drug, according to a computer-assisted analysis of FDA records. Of those deaths, 91 were described as liver-related.