PPH Legal Blog

by Williams Kherkher

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FDA Lenient with Avandia

November 15th, 2007 · No Comments

Yesterday the FDA announced the new “black box” wording for Avandia. The new label has upset many patient advocate groups as it is not a particularly strongly worded new label. They are calling it the latest incidence of the FDA turning a blind eye towards Avandia’s problems.

Avandia’s heart attack risk has been known, apparently, to the FDA since 2005 yet no one said boo until the summer of 2007. A congressional investigation of Avandia and the FDA’s response were also launched.

The new label says that evidence of increased heart attacks is inconclusive even though 42 separate trials had revealed a 43% increase in the chance of heart attacks if a patient takes Avandia.

If you or someone you know has been diagnosed with Primary Pulmonary Hypertension following a type 2 diabetes treatment plan that included Avandia, you may have legal options available to you. Contact the PPH lawyers of Williams Kherkher at 1-866-950-9000 to discuss these legal options and to schedule an initial consultation.

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