PPH Legal Blog

by Williams Kherkher

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Information Withheld from the FDA by Avandia Manufacturer

August 11th, 2008 · No Comments

The United States Food and Drug Administration has been investigating the drug Avandia for some time now. In early 2008, the FDA issued a warning letter to the drug’s manufacturer, GlaxoSmithKline, for postmarketing safety reporting failures.

The large manufacturer claims that any information that was withheld was done so by mistake. GlaxoSmithKline states that the missing information was “inadvertent and not intentional.”  The manufacturer informed the FDA that it would work to ensure that the mistake would never happen again by providing their employees with additional training on reporting requirements.

Although the FDA is working to keep the public informed and safe from dangerous drugs, their attempts may be too late for some who have suffered the dangerous effects associated with Avandia. Back in November 2007, the FDA issued the requirement that a black box warning be placed on the medicine’s packaging, stating that the drug could increase the risk of a heart attack.

If you or a loved one has been injured due to the use of Avandia, contact the PPH lawyers of Williams Kherkher today by calling 866-950-9000.

Tags: PPH lawsuit attorney · Avandia lawsuit · Avandia · Primary Pulmonary Hypertension · PPH lawyer · PPH lawsuit

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