by Steven Ertelt
August 2, 2007
Washington, DC (LifeNews.com) — Food and Drug Administration advisors on Wednesday urged the federal health agency to place fewer restrictions on the acne drug Accutane and generic versions of it. The drug has caused significant problems, such as birth defects, for unborn children since it was first introduced in 1982.
Accutane, also known as isotretinoin, was approved by FDA in 1982 for use in cases of severe recalcitrant cystic acne unresponsive to other therapies including systemic antibiotics.
The drug received a FDA pregnancy category X rating because it caused birth defects in animals and the agency said Accutane should not be used by women who are pregnant or are at risk of becoming pregnant.
But pregnant women used the drug and reports of children born with birth defects due to in utero Accutane exposure became increasingly common.
Pro-life groups complained that, within the FDA, abortion has been viewed as an acceptable solution to the problem of Accutane usage and pregnancy exposure. They also were concerned that drug-maker Hoffman-La Roche also saw abortion as a means of combating potential birth defects.
The FDA addressed the issue over the years and eventually created the iPledge system to monitor usage and prevent women from getting pregnant while on the drug.
The advisors on Wednesday called for more flexibility in rules designed to help encourage women to prevent pregnancies while taking the drug.
Administrators of a program devised to help lower the problems associated with the drug said there were 122 pregnancies during the first year of the program and another 37 in the four months since.
While 35 women who became pregnant left the program, the advisors monitored the rest, according to an AP report. They found that 54 women had pregnancies that ended in abortion and another 17 women had miscarriages while using the drug.
Another 15 women remain pregnant and the one baby who was born to this point escaped any birth defects or other problems caused by the drug.
AP also reported that Accutane’s manufacturer learned of 19 other pregnancies among women using the drug, even though the program was supposed to cover every patient, doctor and pharmacy involved in the drug.
The advisory panel decided that women should fill the prescription for the drug within seven days of a negative pregnancy test and not within seven days of first seeing a doctor for it.
They reaffirmed the desire for all patients to be enrolled in the program and want more detailed follow-up since just 10 percent of the 122 women who got pregnant provided significant information.
Still, Dr. Susan Walker, director of the FDA’s dermatology drugs office, admitted that it is unlikely that the agency will ever prevent all women on the drug from getting pregnant.