Accutane Pregnancy Risks Require Better Warnings About Contraception: Study
Use of the acne medication Accutane during the first trimester of pregnancy has been linked to severe birth defects and complications, yet researchers indicate that many women prescribed the drug are still not being adequately warned about the importance of birth control and the risk of becoming pregnant while taking Accutane.
In a study published in the medical journal JAMA Dermatology on February 4, researchers from the University of Pittsburgh call for women to be given a contraception fact sheet when considering Accutane or generic isotretinoin for acne.
The warning comes after researchers found that more than half the women who visited a dermatology clinic who might be prescribed Accutane overestimate the effectiveness of typical contraceptives.
More than 2,000 women taking Accutane suffered miscarriages or unexpected abortions after taking Accutane between 1992 and 2003, leading the FDA to initiate the iPledge program in 2005. The program calls for prescribers to have female patients of childbearing age who planned to take Accutane promise to use two forms of birth control and take regular pregnancy tests. Only after taking at least two negative tests and taking a contraception test online are women supposed to be prescribed the drug.
In the latest study, researchers surveyed 118 women from one dermatology clinic between April and May of 2014 to determine their contraception knowledge on eight typical contraceptives.
Researchers discovered that 75% of the women overestimated the effectiveness of condoms, 57% overestimated the effectiveness of contraceptive injections, and 51% thought birth control pills were more effective than they really were. The researchers also found that 34% of the women had never even heard of contraceptive implants, and 16% had never heard of an intrauterine device (IUD).
Despite the lack of knowledge, researchers discovered that women spent less than a minute on average reviewing a contraceptive information sheet provided. However, after viewing it, their knowledge on contraceptives increased significantly for all methods of contraception.
“A contraceptive information sheet can significantly improve patients’ contraceptive knowledge and may be a useful addition to efforts to prevent isotretinoin-induced birth defects,” the researchers concluded.
Known generically as isotretinoin, Accutane has been the subject of hundreds of lawsuits over failure to warn about potential health risks associated with the medication.
Roche, the manufacturer of the name-brand drug, faces more than 3,000 Accutane lawsuits filed on behalf of former users who developed inflammatory bowel disease, which could lead to ulcerative colitis, Crohn’s disease or other damage to internal organs. Several of the cases have resulted in multi-million dollar damage awards, but Roche continues to defend the cases at trial.