FDA Pulls the Plug on Avandia Study

At the request of the FDA, GlaxoSmithKline will be putting a stop to its study on Avandia, a drug that is used for treating Diabetes.

Avandia works by increasing the body’s sensitivity to insulin. Insulin is a key protein in digestion and is a protein that diabetics don’t produce. Patients already enrolled in the trial study may continue, but no new patients may enroll at this time.

The FDA put the brakes on the study after hearing from some experts that Avandia increases a person’s chance of a heart attack. GlaxoSmithKline claims that their research found that this was not a side effect. Dr Ellen Strahlman, GSK’s Chief Medical Officer was quoted as saying “This pause in enrollment will give clinical trial investigators and patient’ time to learn about the data presented to the FDA and the committee’s recommendations”. She also stated that “We are committed to working with the FDA in the best interest of diabetic patients.”

Avandia was first approved in 1999 but sales in the US have dropped dramatically since the concerns about the drug have started circulating. The FDA will decide over the next several months whether or keep this medication on the shelves or not.