Guides for high-risk drugs undergoing FDA scrutiny

The agency is seeking appropriate ways to reach patients with vital information on the risks and benefits of certain drugs.

By Susan J. Landers, AMNews staff. July 2, 2007.

Washington -- Medication guides were considered a good idea in 1995 when proposed by the Food and Drug Administration to help patients assess the risk level they faced from particular drugs. But problems have ensued.

The guides aren't always provided to patients, nor are they read and understood, agency representatives were told at a recent public hearing.

Patients, physicians, pharmaceutical companies, researchers and others provided input during the June 12-13 hearing on the handouts, which are given to patients by pharmacists each time certain prescription and biological products are dispensed. Drafted by pharmaceutical companies in collaboration with the FDA, they are intended to prevent serious adverse events.

Risk communication is a particularly timely topic given recent disclosures of serious side effects from drugs long on the market. Reports that the diabetes drug Avandia (rosiglitazone maleate) may increase heart attack risk is the latest in a string of such revelations.

As a result, drug safety has been a front-burner issue in Congress and has been addressed in major Institute of Medicine reports.

"How we communicate about drugs is absolutely critical to ensuring the proper balance between benefits and risk for the products we regulate," said Steven Galson, MD, MPH, director of the Center for Drug Evaluation and Research.

Communication between the FDA, health care professionals and consumers is in "a state of flux," Dr. Galson added, and Internet capabilities are making traditional methods of communicating, including medication guides, look antiquated.