The FDA does not ban – but much more severe restrictions make it difficult for doctors to prescribe drugs for diabetes troubled security.Health information tailored to the needs of people with diabetes. Sign up to receive newsletters from WebMD Diabetes popular.
Hamburg has admitted that the experts are divided on how to interpret scientific data suggest that Avandia FDA damages the heart. Both Avandia and Actos increase the risk. But it seems that only Avandia increases the risk of heart attack.
Avandia is currently 600,000 U.S. patients can continue taking the medication if your doctor has officially certify that their patients understand the risks that the medication is to help them, and no other medications for diabetes can keep their sugar control.
Avandia is available for new patients if they can not reach
control over other agents and can not take Actos, FDA commissioner, Margaret A. Hamburg, MD, said at a press conference. current patients can continue taking Avandia if they understand the risks and benefits.
Questions about the cardiac safety of Avandia should be resolved in the studio RECORD, that Avandia manufacturer GlaxoSmithKline conducted at the initiative of the European Monitoring Centre for Drugs. This study showed Avandia to be safe, but critics have slammed the poor design of the study. In addition, the analysis suggests that the study of the FDA has not reviewed all heart attacks in patients with the study possible.
The action today by the FDA require GlaxoSmithKline to convene a group of independent scientists to review the registration information. This examination may lead the FDA to lift new restrictions on Avandia – or prohibit the drug.
The European Medicines Agency has adopted more stringent measures. European sales of Avandia case is pending in the coming months, although the agency did not formally withdraw recognition.
In a statement, GlaxoSmithKline said it continues to believe that Avandia is an important treatment for patients with type 2 diabetes , but will work with the FDA and European Medicines Agency to implement their decisions.
Janet Woodcock, MD, director of FDA’s drug evaluation and Research, noted that the FDA advisory committee split last July on whether the evidence proved dangerous Avandia.
Avandia manufacturer GlaxoSmithKline will be necessary to establish a risk assessment and mitigation strategy (REMS) program. Patients, their doctors and pharmacists must enroll in the program to receive, prescribe, sell or Avandia. Avandia heart risks clouded by uncertainty