Block Box Warning on Avandia since May 2007

In 1999, a new drug that was meant to benefit type 2 diabetes patients was approved by the US Food and Drug Administration for prescription and use – Avandia, also known under the name Rosiglitazone. Avandia was manufactured by SmithKlineBeecham Corporation (the company is now called GlaxoSmithKline after it merged with Glaxo Wellcome). This oral drug, which decreases the level of blood sugar (glucose), is recommended for type 2 diabetics who, for medical reasons, cannot take Actos or Pioglitazone, or whose bodily system would not respond to other diabetes drugs. It is usually combined with exercise and proper diet or with other anti-diabetic medication, like sulfonylureas or metformin, though it may be taken alone. Type I diabetics should not take Avendia due to the very low, or absence of, insulin in their system.

Avandia became GlaxoSmithKline’s second most used product, being prescribed to more than six million people since its release on May 25, 1999. Multiple studies, however, were made on Avandia due to claims that it increases risk of heart attack and other cardiovascular heart ailments; there were claims that it has even caused the death of some patients. Thus, in August 2007, following a recommendation arrived at during a joint gathering of FDA’s advisory committees made up of the agency’s Drug Safety and Risk Management and the Endocrine and Metabolic Drugs, FDA added the “possibility of increased risk of heart attack” info on the drug’s black box warning label which was first requested by FDA in May 2007 (this first request only stated greater risk of congestive heart failure).

A black box warning (also called boxed warning or black label warning) is the sternest warning that the FDA can issue on a drug which is reported to cause severe and life-threatening side effects. Besides Avandia’s physician labeling and patient Medication Guide, this warning also appears in all forms of literature and advertisements (like in magazines) about the drug.

Due to further studies being made on Avandia, the FDA decided not to pull the drug out of the market yet. Continuous study and increase in reported Avandia side-effects prompted the FDA to notify the public anew (specifically, on February 3, 2011), this time, of the drug’s possible cardiovascular (and heart attack) risks. Though physicians are allowed to continue prescribing Avandia and other Avandia-containing medicines (but only to those who have been using the drug already), patients should be informed of the warnings already issued by the FDA on the drug.