Avandia Restrictions

Avandia Restrictions

Avandia Restrictions Issued

The U.S. Food and Drug Administration has announced that rosiglitazone-containing medications—including Avandia, Avandamet and Avandaryl—will face new restrictions. These medications are used to treat type II diabetes.

The new Avandia restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a statement. The REMS program is in place for the management of marketed drugs with serious health risks for the patient. The restrictions being imposed on rosiglitazone-containing medications are due to the fact that data suggests that there is an elevated risk of heart attack in patients treated with the drug.

Avandia Restrictions will require Patients to Enroll In Program

Previously, the REMS for rosiglitazone, which was initially enacted on Sept. 23, 2010, mandated only that a Medication Guide be provided with the medication. Now, the Avandia restrictions will require healthcare providers and patients to enroll in a special program to prescribe and receive rosiglitazone-containing drugs, Avandaryl and Avandamet.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia; it is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).

According to the REMS, called the “Avandia-Rosiglitazone Medicines Access Program,” limits for the use of rosiglitazone-containing drugs include the following:

• Patients already being successfully treated with these medicines.
• Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Avandia Restrictions to take affect November 18, 2011

After Nov. 18, 2011, rosiglitazone-containing medications will not be available through retail pharmacies. Rather, patients enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their prescriptions via mail order, which will be sent to specifically certified pharmacies participating in the program, the FDA explained.

Patients currently taking a rosiglitazone-containing medication should contact their healthcare provider as soon as possible, to determine if they should continue taking their current medication and, if so, to become enrolled in the Avandia-Rosiglitazone Medicines Access Program. The patient’s healthcare provider will have to complete and sign the patient enrollment form.

The FDA advises healthcare providers that they should determine whether their patients should be taking rosiglitazone medications, based on risks and benefits of the drug versus other available medications. Additionally, healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe the medications.

Access the Avandia-Rosiglitazone Medicines Access Program online, and read more about the restrictions of rosiglitazone-containing medications on the FDA website as well as the Avandia restrictions.