The once blockbuster drug Avandia has been at the center of controversy over the past several months. In May of this year an article was published in the New England Journal of Medicine linking the drug to a 43 percent increased risk of heart attack. The article was based on an analysis of 42 studies that suggested the possible increased risk. Wednesday the FDA added an additional “black box” warning to GlaxoSmithKline’s Avandia to advise patients of this potential risk.
The new warning will also apply to the Glaxo products that combine Avandia with other treatments, called Avandaryl and Avandamet. In a win for Glaxo, the FDA also said it would ask makers of other diabetes drugs to note in their labels that they hadn’t been proven to reduce cardiovascular risk.
In July the FDA issued the first “black box” warning to Avandia in order to warn of an increased risk of heart failure. Glaxo has been rather optimistic when looking at the new warning, as the wording is less damaging than it could have been. GlaxoSmithKline has declined to forecast the future of Avandia, but some have speculated that it may be possible for Avandia to make a comeback even with the new warning for heart attack risk.