The FDA has announced a major tightening on the availability of the diabetes drug Avandia due to the evidence of increased risks of heart issues from the drug. In an unusual move, European officials and the U.S. have acted in concert to limit access to the drug. Europe will suspend sales of the diabetes drug entirely. In the U.S., patients may only be prescribed Avandia when they and their doctor can show that no other drugs are affective and that they are cognizant of the increased risks.
According to the New York Times, the FDA is taking a harder line on drug safety. This is the first time the agency will post memos from senior staff noting strong and sometimes opposing positions on what to do about the diabetes drug.
Critics of the drug such as Dr. Steven Nissen, who has authored studies showing the risks of Avandia, are behind the decision to restrict sales. However, Dr. Nissen has concerns about the process that brought the FDA to its current decision, telling the Times it is, “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.” According to the Times, one study showed more than 47,000 people taking Avandia needlessly suffered a heart attack, stroke, heart failure or died.
Avandia was once the most popular diabetes drug in the world, but sales had already deteriorated after the studies regarding the risks were made public. Sales will drop further as authorities set out the restrictions on the drug.
The Times reports that standards for treatment of this disease, on the rise across the western world, are now going to change. In the past, the FDA had looked only at whether the drug helped control blood sugar levels in diabetic patients. However, due to the heart risks from Avandia, the new standard will likely test whether a new drug improves the quality or length of patients' lives. This is will be a harder standard to reach.
GlaxoSmithKline, the maker of the diabetes drug, stated that “the company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes” and is working with the F.D.A. and European regulators “to implement the required actions.”
Patients currently taking the drug may continue their course of medication.