Avandia Under New FDA Restrictions After Being Pulled in Europe
Silver Springs, MD, United States (AHN) – Controversial diabetes drug Avandia is being pulled across Europe and will only be available in the United States under tough new restrictions.
The U.S. Food and Drug Administration announced Wednesday that new restricted guidelines governing the use the use of the drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.
The new restrictions are in response to data that suggests an elevated risk of cardiovascular events, such as heart attack and stroke, in patients taking the medication. Despite the risks and the European Medicines Agency concluding it was too dangerous to use, the FDA will continue the drug’s administration under the strictest circumstances.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Dr. Margaret A. Hamburg. “We are seeking to strike the right balance to support clinical care.”
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Rosiglitazone also is available in combination with other diabetes medications–metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
GSK reaffirmed its stand behind the drug and says it will work with U.S. and European regulators to prove its safety.
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