FDA Asks for Tougher Warnings on GnRH Agonists
Posted on 20. Oct, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA has asked manufacturers of gonadotropin-releasing hormone (GnRH) agonists — a class of drugs used primarily to treat prostate cancer — to add new warnings about the potential risk for heart disease and diabetes.
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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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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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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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ADA: Safety Key to Developing Diabetes Drugs
Posted on 27. Jun, 2010 by Dr. Ellis in News and Updates
ORLANDO (MedPage Today) — The high bar set by the FDA for new diabetes drugs to prove cardiovascular safety was overdue, not overkill, a leading cardiologist said here.
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CODHy: Diabetes Docs Skeptical of FDA Drug Safety Policy
Posted on 14. May, 2010 by Dr. Ellis in News and Updates
PRAGUE (MedPage Today) — At least some in the diabetes community remain unconvinced that the FDA’s demand for extensive cardiovascular safety data on new drugs will ultimately help patients, researchers indicated here.
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Preterm Birth Issue Explored by House Panel
Posted on 13. May, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Premature births appear to be associated with a mix of factors — including previous preterm birth, high blood pressure, and diabetes — but how those factors intertwine remains a mystery.
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High-Risk Pools Will Tackle Preexisting Conditions
Posted on 04. Apr, 2010 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Taking its first action under the healthcare reform law, the Obama Administration announced that it will help states establish temporary high-risk pools to provide health insurance to people who cannot obtain it due to preexisting medical conditions.
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Retail Clinics Branch into Chronic Disease Treatment
Posted on 25. Mar, 2010 by Dr. Ellis in News and Updates
Retail clinics aren’t just for strep throats any more; they’ll also be managing diabetes and other chronic diseases.
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