U.S. says some SmithKline Avandia claims misleading

WASHINGTON (Reuters) -- SmithKline Beecham Plc has circulated misleading information about its diabetes drug Avandia and its use by people with liver impairment, U.S. regulators charged in a letter made public on Tuesday.

Avandia is in the same family of drugs as Rezulin, a drug Warner-Lambert Co., now part of Pfizer Inc., pulled from the market in March after it was linked to dozens of liver failures.

Avandia is considered safer than Rezulin. But the drug's label recommends several precautions to reduce any chances of liver damage while doctors and patients gain more experience with the relatively new drug.

In a letter dated Oct. 20, the Food and Drug Administration said it was "seriously concerned" that some SmithKline promotional materials had "minimized the precautions" regarding liver damage.

The FDA ordered SmithKline to stop disseminating information the agency called "false and misleading" in various sales aids and other materials.

The drug's FDA-approved label notes that Avandia, which treats Type II or adult-onset diabetes, is chemically related to Rezulin. Avandia's label advises that the drug should not be given to diabetics with acute liver disease or elevated levels of liver enzymes, patients that would be considered "hepatically impaired."

In one sales material, SmithKline claimed Avandia was "appropriate for many patients with type 2 diabetes including obese, elderly and renally or hepatically impaired" patients.

Also, an advertisement in a medical journal detailed Avandia's power to control diabetes but failed to mention any liver-related precautions, which include routine testing to look for early signs of harm, the letter said.

The agency also took issue with some claims about Avandia's effectiveness "because they suggest that Avandia is more effective than has been demonstrated by substantial evidence."

SmithKline spokesman Brian Jones said the company would work with the FDA, "and if any adjustments are necessary, we'll make them."

The FDA posted the letter from its division of drug marketing, advertising and communications on its Web site late Tuesday. The agency routinely monitors drug companies' promotions to make sure materials present accurate and balanced information about risks and benefits.

SmithKline is planning to merge with Glaxo Wellcome Plc. Avandia, known generically as rosiglitazone, was approved in the United States in May 1999. It is part of a class of drugs known as glitazones or thiazolidinediones, which also includes Actos by Eli Lilly and Co. and Takeda Chemical Industries.

Copyright 2000 Reuters. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Diabetes drug Rezulin taken off market
March 22, 2000
FDA reviews diabetes drug linked to dozens of deaths
March 26, 1999

Food and Drug Administration
A Closer Look at Oral Diabetes Drugs

Note: Pages will open in a new browser window

External sites are not endorsed by CNN Interactive.