FDA sets up national registry for acne drug
■ Some dermatologists question whether this approach will help reduce the risk of congenital anomalies posed by isotretinoin.
By Susan J. Landers — Posted Sept. 12, 2005
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Washington -- The Food and Drug Administration is requiring that physicians and patients register on a new Internet database called iPLEDGE before they can prescribe or receive the acne medication isotretinoin, also known by the brand names Accutane, Amnesteem, Claravis and Sotret.
The heightened precautions, designed to reduce the number of pregnant women exposed to the drug, will go into effect Dec. 31. The iPLEDGE site was scheduled to be opened for registrations from physicians and others this month.
The warnings associated with isotretinoin have steadily increased since the FDA's first risk-management program was instituted in 1988. Introduced in 1982, the drug has long been known to increase the risk for congenital anomalies, but its effectiveness as a treatment for severe recalcitrant nodular acne has also been unrivaled.
The FDA announced the registry requirements Aug. 12, when it also alerted doctors to watch for signs of depression or suicide among patients taking the medicine. The agency said it was continuing to monitor potential psychological side effects.
These recent actions were applauded by the March of Dimes, which estimates that at least 2,000 pregnancies among women taking the drug have been reported over the years. Roche Pharmaceuticals, the manufacturer of Accutane and a developer of the new registration program, also welcomed the FDA's approval of iPLEDGE. "The program's development has been an exemplary collaborative effort among Roche, the generic manufacturers and the FDA," according to a company statement.
Although it is a new enterprise, many say the implementation of iPLEDGE is not expected to change physicians' prescribing practices in any fundamental way. Accutane and its generic equivalents, for instance, are already tightly regulated and controlled, noted Andrew Werchniak, MD, an instructor in dermatology at Harvard Medical School and a physician at Brigham and Women's Hospital in Boston.
Women of childbearing age must already have two pregnancy tests before the drug can be prescribed, and monthly pregnancy tests while taking it. All patients must be seen monthly.
The biggest change brought about by the regulations is the establishment of a national registry, said Lowell Goldsmith, MD, MPH, clinical professor of dermatology at the University of North Carolina at Chapel Hill School of Medicine. But he questioned its likely effectiveness.
A registry is not likely to help detect cases of depression or potential suicide, nor will it take into account the very real failure rate of properly used contraceptives, he said. "I think it is a bureaucratic attempt to address a serious medical problem."
However, because physicians will be required to report unexpected pregnancies, the registry could help gather an accurate count, said Dr. Werchniak. And it may help determine the reasons for them. Registering could also reinforce physicians' warnings to patients not to become pregnant, he added.
"But it remains to be seen if it is useful in reducing the number of pregnancies," he said. "Perhaps somewhat cynically, I doubt that simply registering is going to have a significant effect."
Dermatologists fear that if this latest step does not reduce the number of pregnant users, the drug could be taken off the market. And there are no good alternatives. "The only reason it is on the market is that there are many patients, especially those with nodular or cystic acne, who simply can't be effectively treated with any other modality," said Dr. Werchniak.
And should it be taken from the market, patients who are desperate to obtain it could resort to buying it over questionable Internet sites, he said.
Alternative treatments are also generally less effective, said Dr. Goldsmith. One alternative, high doses of vitamin A, poses risks that include congenital anomalies. And patients with such chronic, life-long disorders as Darier disease, could also be denied effective treatment, he noted.
The American Academy of Dermatology is monitoring the situation, said Barbara Reed, MD, chair of the academy's Ad Hoc Task Force on Isotretinoin, and will continue to do so to determine whether any prescribing problems emerge after the new program is instituted.