The U.S. Food and Drug Administration (FDA) claims that GlaxoSmithKline, PLC withheld nine studies related to Avandia, its popular diabetes drug, after an inspection of the company’s North Carolina offices. Research has linked Avandia to a significant increase in heart attacks.

FDA inspection

The FDA inspected GlaxoSmithKline’s (GSK) Research Triangle Park offices in North Carolina from August 20 to November 15, 2007 after reports published in the New England Journal of Medicine (NEJM) reported that Avandia, GSK’s popular diabetes drug, increased the rate of heart attacks by 43%. It found that GSK failed to report information on nine studies related to Avandia and required the pharmaceutical giant to respond with a plan to ensure that all relevant studies are reported to the FDA in the future. To view the FDA’s letter, go to: www.fda.gov/foi/warning_letters/s6714c.htm.

What is Avandia?

Avandia is prescribed to those with type 2 diabetes, which is the most common form of diabetes and affects nearly 18 million Americans and 200 million people worldwide. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Avandia came on the market nine years ago and a reported six million people had prescribed to it at one time. Although the drug was never recalled, both the FDA and European regulators required GSK to include stronger warnings on the drug’s labeling.

Studies show link to heart failure

At least two published studies report that Avandia use is directly linked to an increase in heart attacks, including:

• NEJM. The New England Journal of Medicine published a study in May 2007 which reported a 43% increase in heart risks for patients taking the drug. This was the most damaging study to GSK’s diabetes drug.
• ICES. A study conducted by the Institute for Clinical Evaluative Science (ICES) for the Ontario government, showed that patients taking Avandia had a 60% greater risk of heart failure, a 40% greater risk of having a heart attack and a 29% greater risk of death.

If you’ve experienced heart issues while taking Avandia, contact an attorney whose practice focuses in this area of law. To contact an attorney near you, please click here. Consultations are free, without obligation and strictly confidential.