FDA Advisory Panel Recommends to Decrease Safety Restrictions on Avandia®
According to a recent report, on May 31, 2013, an advisory panel issued a non-binding recommendation to the FDA to decrease safety restrictions on Avandia®, a type-2 diabetes oral medication. The recommendation from the advisory panel is based on new data suggesting that the drug may not increase a patient’s risk of heart attack as much as initially thought. This meeting marked the third time that the advisory panel has assembled to determine whether Avandia® increases the risk of heart attacks.
On May 21, 2007, the FDA issued a safety alert on Avandia® reporting that “safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia®.” On November 14, 2007, the FDA added a boxed warning for heart-related risks to the Avandia® label.
After three years of debate, the FDA limited access to the drug in the United States, while European regulators banned the drug entirely in Europe. Under the FDA’s current risk-evaluation management strategy (REMS), Avandia® can only be dispensed in the United States by specially licensed pharmacies. Also, before prescribing Avandia®, doctors must sign a waiver affirming that they understand the drug’s risks and that their patient has not responded to other diabetes medications.
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