FDA mandates registry for isotretinoin users

January 1, 2005

National report - Monitoring of all patients who take isotretinoin, an acne medication that can cause serious birth defects, will soon become mandatory. The U.S. Food and Drug Administration (FDA) has announced plans for a centralized registry to track patients who take the drug, doctors who prescribe it and pharmacies that dispense it, starting in July.

"The goals of the registry are multiple and include ensuring that females of childbearing age are not pregnant when treatment begins and do not become pregnant during treatment," says Christine S. Parker, public affairs specialist for the FDA. "To accomplish these goals, the strengthened program will seek to ensure that all patients are fully informed about the potential risks and benefits of isotretinoin use and the steps they can take to minimize these risks, and that they receive appropriate counseling and education throughout their treatment course."

The joint database will be shared by all four manufacturers of the drug, prescribed for patients with severe acne that is unresponsive to other treatment. To date, the companies have tracked only prescribers, under a voluntary program.

Dr. Reed is an associate clinical professor of dermatology at the University of Colorado Health Sciences Center in Denver and chair of the Ad Hoc Task Force on Isotretinoin for the American Academy of Dermatology Association (AADA).

Changes Under the new program, before a pharmacy may fill a patient's first isotretinoin prescription, the registry must contain documentation that patients received education about the drug from their prescriber, that an appropriately timed pregnancy test was negative, and that patients completed informed consent as well as education and risk management components.

For repeat scripts, there must be evidence of ongoing patient education, another negative pregnancy test, and repeated completion of education and risk management components by the patient.

Privacy will be maintained through use of unique identifying numbers. According to the FDA's Web site, where all journalists were directed, "Privacy concerns are of critical importance. They have been carefully considered from the beginning and will continue to be taken into account as the details of the program are finalized."

Manufacturers of isotretinoin, which include Roche Pharmaceuticals as well as the makers of three generics - Barr Laboratories Inc., Mylan Laboratories Inc. and Ranbaxy Laboratories Ltd. - are responsible for maintaining the registry, monitoring its efficacy and ensuring compliance. They have contracted with Covance Inc. to design, build, implement and operate the system. They have also successfully negotiated with Celgene Corp. to use elements of its patented risk management program, which helped reduce pregnancy exposures to thalidomide.

According to Dr. Reed, physicians, patients and pharmacies will initially have a learning curve, but once the program is well under way, it should not cause great inconvenience. Those who choose not to comply can simply opt out of being involved with the drug. "The extent to which this will happen remains to be determined," she says.

Doctor unconcerned For his part, Neil Sadick, M.D., F.A.C.P., F.A.A.C.S., is not concerned about how the new regulations will affect his New York City dermatology practice. "I think it's going to necessitate that patients are followed on a strict schedule," he says. "They may need to be seen a little more frequently. ... We follow our patients anyway with blood (tests) monthly. So, my practice won't change." Dr. Sadick is a clinical professor in the department of dermatology at Weill Medical College of Cornell University.

He agrees that the FDA's new rules are warranted. "The only real problems that have occurred with (isotretinoin) have been basically based on pregnancy issues. ... I think it does need to be regulated. Otherwise it will end up like thalidomide, and we'll see a lot of deformed children and a lot of unnecessary fetal death."