Endocrinologist Reflects on Rosiglitazone
Posted on 22. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — As the FDA processes the vote and discussion from last week’s advisory committee meeting on rosiglitazone (Avandia), an endocrinologist who has twice voted to keep the diabetes drug on the market dissected what the recent vote means in a perspective published in the New England Journal of Medicine.
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FDA Orders Enrollment Freeze on Rosiglitazone Trial
Posted on 21. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA has ordered GlaxoSmithKline, the maker of rosiglitazone (Avandia), to stop enrolling patients in its ongoing head-to-head outcomes trial comparing the drug with pioglitazone (Actos).
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Keep Rosiglitazone on the Market, FDA Panel Says
Posted on 14. Jul, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — An advisory panel voted 20-12 to recommend that the FDA allow rosiglitazone (Avandia) to stay on the market, but most panelists want to see the controversial diabetes drug carry tougher warnings on its label.
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FDA Staffers Blast Rosiglitazone at Advisory Panel Meeting
Posted on 13. Jul, 2010 by Dr. Ellis in News and Updates
GAITHERSBURG, Md. (MedPage Today) — The two major FDA critics of rosiglitazone (Avandia) again denounced the diabetes drug during the first day of an advisory committee meeting that will end with a vote on whether the agency should pull it from the market.
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Advisory Panel Faces Tough Call on Rosiglitazone, Experts Say
Posted on 12. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Despite hints that the FDA may be leaning toward pulling rosiglitazone (Avandia) from the market, it’s going to be a tough decision for the advisory committee slated to begin meeting on Tuesday, and things could still go either way, leading endocrinologists predict.
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Washington Week: FDA Staff Slam Avandia; Obama Instals Berwick in CMS Post
Posted on 11. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — FDA reviewers suggest pulling rosiglitazone (Avandia) from the market and President Obama uses a recess appointment to putget Donald Berwick, MD, into the seat as head of CMS.
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Take Rosiglitazone Off the Market, Says FDA Staff
Posted on 09. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Rosiglitazone (Avandia) should be pulled from the market because of the “serious” cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.
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Rosiglitazone: FDA Prepares for a Verdict
Posted on 09. Jul, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA advisory panel scheduled to meet next week to review the cardiovascular safety of rosiglitazone (Avandia) will have 2,000 pages of briefing documents — including a special report from the Institute of Medicine — to guide members as they decide the future of the drug.
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