GlaxoSmithKline Plc's (NYSE:GSK) diabetes drug, Avandia, looks like it's going to get hit again. The Wall Street Journal is reporting that the FDA wants to increase the warning label on the drug.
Avandia first came under fire last May when it was linked to a 43% higher risk of heart attack in patients. The drug already has a strong 
warning but it advises patients of heart failure, not heart attack. The FDA wants to have the 2nd warning added so that patients will be fully aware of the risks associated with the product.
The European Medicines Agency has recommended that Avandia have a stronger warning label as did an advisory panel of the FDA last July but both believe that it should stay on the market as its benefits outweigh the risks.
Glaxo has already cut jobs in anticipation of the impact to earnings in 2008 due to the expected decrease Avandia sales.
[Source: Telegraph]
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» Avandia May Raise Risk of Osteoporosis from PharmaGazette
Researchers at the Salk Institute for Biological Studies in La Jolla, Calif. believe that the diabetes drug, Avandia, may increase bone thinning, osteoporosis, which may explain why diabetics have an increased risk of fractures.Research has found the p... [Read More]
Tracked on: December 3, 2007 10:42 AM | Permalink to Trackback