FDA's Avandia Trial Should Be Stopped

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An advocacy group is urging regulators to stop a global study of the diabetes drug Avandia, manufactured by GlaxoSmithKline, stating that the study is putting participants at risk of serious side effects associated with the medication.

Avandia has been in the news since 2007, when the drug was linked to an increased risk of chest pain and heart attack. Following evidence linking Avandia to these adverse reactions, the U.S. Food and Drug Administration (FDA) requested that GlaxoSmithKline evaluate Avandia in another trial to compare the drug to Actos, another type 2 diabetes medication.

According to Public Citizen's Health Group Research Director Sidney Wolfe and researcher David Juurlink, the Avandia study is "exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over its comparator."

Wolfe and Juurlink added that Avandia patients are typically uneducated about the safety differences between Avandia and Actos treatment prior to agreeing to participate in the trial, known as TIDE.

An FDA spokeswoman said the trial will be reevaluated based on "expert input and our own analysis," and the FDA will "respond accordingly" following a discussion at a joint advisory committee meeting in July.

Public Citizen sent a letter to the FDA, urging the organization to halt the Avandia trial before the July meeting, stating that both U.S. and European diabetes organizations have come out against the medication.

Additional information about drugs and drug side effects may be found on DrugWatch.com.