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Avandia Side Effects Prompt New Caution from American Diabetes Association

Nov 27, 2007 | Parker Waichman LLP

Risks associated with Avandia have led the American Diabetes Association to call on doctors to use more caution when prescribing oral medications to treat people with type two diabetes.  The Association announced on Tuesday that it was updating its "consensus statement" on the use of oral diabetes medications in light of the increased heart attack risks linked to some diabetes medicines, such as Avandia.

Avandia's heart attack link came to light in May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43% higher risk of having a heart attack.  Earlier this month, the Food & Drug Administration (FDA) announced the addition of a long-awaited black box warning for Avandia's increased risk of heart attacks.  However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia's safety issues, and have called on both GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.

The American Diabetes Association's revised consensus statement was formulated in cooperation with European Association for the Study of Diabetes.  The statement reads in part: "New information suggests additional hazards associated with the use of either thiazolidedione, and rosiglitazone (Avandia) in particular may result in an increased frequency of myocardial infarctions. . . We therefore recommend greater caution in using thiazolidediones, especially in patients at risk of, or with, congestive heart failure."

The American Diabetes Association's new Avandia stance is only the latest development that could hurt the drug's sagging sales.  In October, the United States Department of Veterans Affairs (VA) announced that it was dropping Avandia from its prescription drug formulary. In a statement announcing the move, the VA said that it had conducted its own review and concluded that, for some patients, Avandia did not afford the same margin of safety as other diabetes medications. Prior to its announcement, the VA accounted for about 8% of Avandia's sales in the United States. And in November, Health Canada sent a letter to Canadian health professionals informing them that Avandia could no longer be prescribed as monotherapy for type 2 diabetes, except when metformin use is contraindicated or not tolerated. Health Canada also withdrew its approval for Avandia to be used in combination with a sulfonylurea, except when metformin is contraindicated or not tolerated.

Last week, Glaxo got more bad news on the Avandia front when a Congressional Committee Report found that company executives made a concerted effort to intimidate  Dr. John Buse, a diabetes expert, into keeping quiet about some of the Avandia's safety problems. The report alleged that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.

Avandia was once Glaxo's second biggest selling drug, but sales in the US dropped 48% after the Cleveland Clinic published its heart attack study.


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