On Wednesday the FDA announced that the type-2 diabetes drug Avandia would now carry a additional “black box” warning. The “black box” warning is the strictest label that can the FDA can place on a medication. The new warning will cite a May New England Journal of Medicine article that demonstrated a possible link between Avandia and an increased risk in heart attack. The warning does not confirm the possible link to heart attack risks but rather warns patients of a possible increased risk.
The recent move has been speculated for several months and sales of Avandia have plummeted since the study was published. Sales have fallen almost 50 percent from last year and the future for the one blockbuster drug has yet to be determined.
GlaxoSmithKline has been rather optimistic about a possible comeback for Avandia and have dodged a very large bullet with new warning’s wording not being that detrimental to the future plans. Rival drug, Actos, has benefited most by the current controversy surrounding Avandia. The manufacturer of Actos, Takeda, has said that they are planning an intensive marketing program in the wake of the Wednesday announcement.
For more information on this subject, please refer to the section on Drugs, medical Devices and Implants.
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