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FDA Announces New Restrictions on Avandia Access

In a September 23, 2010 news release, the FDA announced that it will “significantly restrict” the use of the diabetes drug Avandia to Type 2 diabetics who cannot control their diabetes on other medications, and who are unable to take Actos, the only other drug in the thiazolidinedione class. These restrictions are a result of study data that suggests an elevated risk of heart attack and stroke in patients using Avandia, manufactured by GlaxoSmithKline.
Under the restrictions, doctors will be required to certify and document their patients’ eligibility for access to Avandia, and patients who desire to continue to use the drug must acknowledge that they have been informed of and understand the risks.
The FDA is continuing to study the drug and may take additional action as warranted.
More Avandia related postings:
Between a Rock and a Hard Place,” Colorado Business Litigation Lawyer Blog, posted 09/21/10
Avandia Health Concerns Crosses the Pond,” Colorado Business Litigation Lawyer Blog, posted 09/08/10
Update on the Avandia/Actos Saga,” Colorado Business Litigation Lawyer Blog, posted 09/02/10
An Introduction to Business Ethics,” Colorado Business Litigation Lawyer Blog, posted 08/18/10