08222017Headline:

Philadelphia, Pennsylvania

HomePennsylvaniaPhiladelphia

Email Jamie Sheller
Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

Avandia Data Withheld from the FDA

Comments Off

Avandia drug manufacturer, GlaxoSmithKline, failed to disclose several studies about Avandia to the FDA. Earlier this year, the FDA issued a warning letter to GlaxoSmithKline for postmarketing safety reporting failures. This letter can be viewed at http://www.fda.gov/foi/warning_letters?s6714c.pdf. GlaxoSmithKline suggested that any omission of data was inadvertant and not intentional. In order to prevent this from happening again, GlaxoSmithKline intends to provide additional training to its employees on reporting requirements. For some injured by this drug, this may be too little too late. In November 2007, FDA officials required a black box warning that the medicine may increase the risk of heart attack. If you or a loved one has been injured by this product, you should speak with an attorney to evaluate your case.