Wednesday, December 17, 2008

The Avandia fallout

Drug companies should more thoroughly study the potential heart risks of new diabetes medicines, U.S. health officials said on Wednesday.

The Food and Drug Administration, in new guidelines, outlined steps companies should take "to ensure that a new therapy does not increase cardiovascular risk to an unacceptable extent."
The decision will mean longer and more expensive studies for many companies seeking to sell new therapies in a $6 billion U.S. market that was hit by safety concerns with GlaxoSmithKline Plc's diabetes pill, Avandia.

Several drugmakers, including Glaxo, Bristol-Myers Squibb Co, AstraZeneca Plc, Eli Lilly and Co and Amylin Pharmaceutical Inc, are working to bring new diabetes drugs to the market.

Until now, companies generally needed to show only that their diabetes medicines lower blood sugar.


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