FDA Severely Restricts Avandia
New prescriptions for the type 2 diabetes medication rosiglitazone (Avandia) will only be permitted for people who are both unable to control their blood glucose with other diabetes medications and unable to take the only other drug in the same class, pioglitazone (Actos). The ruling today by the Food and Drug Administration (FDA), which will take several months to implement, also allows people who currently take rosiglitazone to continue doing so. The agency expects that these actions will "significantly" limit the use of this medication.
Concerns about rosiglitazone's safety arose in 2007 after an analysis of earlier research found that the medication increased the risk of heart attacks. Since then, there have been numerous additional studies exploring the link. The FDA concluded that the available evidence contains "signs for concern" but does not provide "robust or consistent" information on whether rosiglitazone causes heart attacks. The FDA will now require health care providers to document that they've shared information about rosiglitazone's risks with any patient who is prescribed the medication.
The FDA's decision was released at the same time as that of its counterpart agency in Europe. However, the European regulators decided to withdraw rosiglitazone from the market entirely. "Each agency is managing this risk of rosiglitazone with what it believes is the best risk management tool it has for this circumstance,"said FDA press officer Karen Riley in an e-mail. "Those tools are different and reflect the different regulatory environments in Europe and the United States."
Rosiglitazone and pioglitzaone are thiazolidinediones, or TZDs, which work to improve blood glucose control by making people more sensitive to insulin. A clinical trial designed to compare the cardiovascular safety of the two medications directly has been suspended as part of the ruling. The trial is known as TIDE, for Thiazolidinedione Intervention With Vitamin D Evaluation,
The American Diabetes Association, in a joint statement with the Endocrine Society and the American Association of Clinical Endocrinologists, urges people who take rosiglitazone or any combination pill that includes it (Avandamet and Avaglim) to contact their diabetes doctor for "instructions about treatment options." There are several classes of type 2 diabetes medications, offering multiple treatment alternatives. Discontinuing medication without consulting a physician can lead to high blood glucose and diabetes complications.