Breaking News: REMS now available for Avandia; access to drug restricted

May 19, 2011

FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy.

FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy (REMS). The new restrictions require healthcare providers, including pharmacists, and patients to enroll in a special program in order to prescribe, dispense, and receive these drugs.

In addition, after November 18, 2011, rosiglitazone medications will no longer be available through retail pharmacies. Patients will receive their medications by mail order through specially certified pharmacies participating in the program. GSK will withdraw rosiglitazone drugs from the current supply chain and will provide pharmacies with instructions on returning the medications.

The National Community Pharmacists Association (NCPA), which is still reviewing the FDA announcement concerning its updated REMS for Avandia and other rosiglitazone-containing medicines, said in a statement that “we feel that any state-and DEA-licensed pharmacy, including community pharmacies, should be eligible to dispense specific REMS products. Restricted distribution programs may interfere with patient access to prescribed therapies. In addition, studies and experience indicate that direct face-to-face counseling is more effective than mailing medication and offering counseling through a call center phone bank.”

If independent community pharmacists choose to participate in a REMS program and meet all the requirements, including being on call 24 hours a day, they should be able to dispense products that are common to retail pharmacies such as Avandia and should not be restricted by a “special arrangement,” NCPA stated.

FDA’s decision to restrict access to rosiglitazone medications was made on September 23, 2010, following analysis of data suggesting an elevated risk of cardiovascular events, such as heart attack and stroke, in type 2 diabetes patients treated with the drugs. At that time, there was no mention of eliminating distribution of the drugs from retail pharmacies.

“The FDA is taking this [regulatory] action to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, MD, during a press conference in late September 2010. “We are seeking to strike the right balance to support clinical care.”

The REMS, called the Avandia-Rosiglitazone Medicines Access Program, limits the use of rosiglitazone medications to:

• Patients who are already being successfully treated with these drugs
• Patients whose blood sugar cannot be controlled with other antidiabetic drugs and who, after consulting with their healthcare providers, do not wish to use pioglitazone-containing medications (Actos, Actoplus Met, Actoplus Met XR, or Duetact)

According to the FDA website, the prescribing of rosiglitazone drugs declined sharply following FDA’s September announcement. “The projected number of patients filling rosiglitazone-containing product declined 50% from 235,500 patients in January 2010 to approximately 119,000 in October 2010,” reported an FDA communication.