FDA To Increase Efforts To Warn Pregnant Women Against Use of Acne Medication Accutane
FDA on Tuesday announced a new plan to strengthen efforts to prevent pregnant women from taking Roche's acne drug Accutane and generic versions of the drug, known as isotretinoin, USA Today reports (Rubin, USA Today, 11/24).
Studies have shown that Accutane, which FDA approved in 1982 to treat severe cases of acne, can cause severe side effects in pregnant women, such as birth defects and fetal death, and also might cause depression and suicide (Lane, Long Island Newsday, 12/12/02). As a result, Roche in April 2002 started a program that requires doctors to place a yellow sticker on prescriptions for Accutane to verify that female patients of childbearing age who were prescribed the drug had taken a pregnancy test and received a negative result. Pharmacists are not supposed to fill the prescription without the sticker (Wilde Matthews, Wall Street Journal, 2/18).
In addition, female patients of childbearing age are required to use two forms of contraception, can only receive a 30-day supply of the drug and are required to take monthly pregnancy tests before they can get a refill (Dow Jones News Service, 11/23). Makers of the generic form of the drug began similar initiatives.
However, FDA in February released data showing that such measures have had little effect on the number of women who take the drug while pregnant, and an FDA advisory panel recommended mandatory enrollment in a central registry system for all patients taking isotretinoin (Ault, New York Times, 2/28). In addition, David Graham, a drug reviewer in FDA's Office of Drug Safety, last week told a Senate committee that the agency has "not done enough" to ensure pregnant women were not taking the drug, according to USA Today.
The new plan, expected to go into effect in July 2005, will require doctors who prescribe isotretinoin, pharmacists who dispense the drug and patients who take it to register with a central clearinghouse, USA Today reports. In addition, any woman of childbearing age who is prescribed isotretinoin must present a negative pregnancy test before filling a prescription for the drug (USA Today, 11/24).
According to FDA, the pharmaceutical company Celgene -- which manufactures Thalomid, a drug also known to cause severe birth defects when taken by pregnant women -- will license the rights to the national registry it developed for Thalomid to Roche and generic isotretinoin makers Barr Laboratories, Mylan Laboratories and Ranbaxy Laboratories so they can establish a similar registry for isotretinoin users, the Newark Star-Ledger reports.
The companies have hired Princeton, N.J.-based clinical research company Covance to develop the registry (Todd, Newark Star-Ledger, 11/24).
FDA spokesperson Kathleen Quinn said it was "definitely a coincidence" that the announcement of the new plan came shortly after Graham raised concerns about Accutane at the Senate hearing. She added, "This is something that we have been working on since not too long after the advisory committee meeting in February. Nine months does seem like a long time, but, considering everything that had to take place, we really moved as fast as we could" (USA Today, 11/24).
However, Rep. Bart Stupak (D-Mich.) said, "Due to congressional pressure and increased public scrutiny, the FDA is finally implementing the recommendations the first two FDA advisory committees made four years ago," adding, "A mandatory registry for all prescribers and patients, providers and pharmacists is a first step, but it's 22 years too late" (AP/Long Island Newsday, 11/23).
Roche spokesperson Carolyn Glenn said the new deal "is an enhancement of what we already have" (Newark Star-Ledger, 11/24).
However, FDA in a statement said that "the multiple programs created confusion and the concern that patients would not receive appropriate counseling and testing to prevent the possibility of birth defects" (FDA Talk Paper, 11/23).
March of Dimes Medical Director Nancy Green said the plan was "a major step forward," but she expressed concerns that FDA will continue to allow Internet sales of isotretinoin. She also "questioned the wisdom" of approving the generic versions of the drug because "patients might not realize they're the same as Accutane," USA Today reports (USA Today, 11/24).