Proposed Black Box Warning for Avandia
October 26, 2007
www.AngelReyesBlog.com
U.S. Food and Drug Administration officials are strongly advising GlaxoSmithKline, to add "black box warning" to its diabetes drug Avandia, according to a recent Wall Street Journal ad. This warning is the strongest given by the FDA. Once a top-selling drug, Avandia's sales have plummeted since it was linked to a 43 percent higher risk of heart attack, according to a May, 2006 study.
Avandia already has an FDA black box warning for heart failure, meaning a weakened heart cannot effectively pump blood. A heart attack risk warning would be even more serious, and could send the drug's sales into a downward spiral.
According to Shaojing Tong, an analyst at Mehta Partners, "This issue has been discussed in detail at the last FDA panel, so it's sort of expected." He went on to say that Avandia's market share could fall even more if the black box warning is implemented.
In 2006, Avandia's world-wide sales were 3.24 billion,
making it the company's second biggest selling drug.
©2007
Angel Reyes
Read more articles by Angel Reyes at AngelReyesBlog.com.
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