- July 30, 2007
The FDA Advisory Committee met July 30, 2007, and reviewed the safety data on
rosiglitazone (Avandia). Despite dire warnings from one FDA staffer who advised pulling it from the market, the AdComm voted to allow it to remain on the market.
[Story at Dr. Bill's Blog at MyDiabetesCentral.com:
FDA Advisors advise continued access to Avandia.]
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- July 28, 2007
The FDA has posted presentations for the upcoming Advisory Committee meeting about
Avandia
and
Actos
at
Endocrinologic and Metabolic Drugs Advisory Committee:
- July 24, 2007
Drinking as little as one can of soda per day -- either regular or diet -- is associated with a 48 percent increased risk of "metabolic syndrome," a key predecessor of heart disease and diabetes, according to a recent study. The authors have
called for further studies to replicate the results and to understand the mechanisms driving this association before recommendations can be made.
Soft Drink Consumption and Risk of Developing Cardiometabolic Risk Factors and the Metabolic Syndrome in Middle-Aged Adults in the Community
Circulation Jul 2007; doi:10.1161/CIRCULATIONAHA.107.689935
[Story at IndyStar.com;
Abstract at
Circulation;
full text at
Circulation
(PDF file).
A commentary on this article may be found at
Drinking diet soda pop: helpful or harmful?]
- July 23, 2007
Novartis AG received positive news on its diabetes medication Galvus Thursday when Europe's drug regulating body recommended its approval to the European Commission.
Recommendations by the European Committee for Human Medicinal Products usually lead to approval by the commission, allowing the drug to be sold in the 27 EU member states plus Iceland and Norway.
Galvus is touted as a possible blockbuster for Novartis, but its U.S. approval was delayed when the FDA in February requested further data.
[Story at International Herald Tribune:
EU medicines panel recommends Novartis drug Galvus for diabetes treatment.]
- July 2, 2007
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet in late July to discuss the cardiovascular ischemic and thrombotic (heart-related) risks of thiazolidinediones, focusing particularly on rosiglitazone (Avandia).
[Story at the FDA website; reproduced at the Diabetes Monitor:
New Safety Information on Diabetes Drug Rosiglitazone.]
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