By: Laurie Edwards for Fibroids1Despite the potential for severe birth defects if taken during pregnancy, a new study suggests that women who use the powerful acne drug Accutane are not following guidelines set up for them closely enough. Fortunately, the FDA is now mandating even more stringent policies for women on Accutane, utilizing communication between patients, doctors and pharmacists to ensure safety.
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Know the facts about Accutane:
Accutane is an extremely strong medication that is intended for those people with severe nodular acne.
It causes a variety of serious physical and developmental birth defects in babies.
Birth defects from Accutane can occur before women even realize they are pregnant. If you’re considering using it, it’s essential to comply with the guidelines in iPLEDGE.
The most important thing is communication: The more doctors, patients and pharmacists work together, the less likelihood there is a women will get pregnant while using Accutane.
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Accutane, manufactured by Roche Pharmaceuticals since 1982, is a synthetic relative of vitamin A that is used to treat a severe type of acne called nodular (or cystic) acne, a condition that affects hundreds of thousands of people a year. Nodular acne doesn’t always respond to other acne medications on the market or to topical creams and lotions, while Accutane can provide relief for extended periods of time.
Even if it is a low dosage for a short period of time, Accutane poses an extremely high risk of birth defects. They include enlargement of the fluid-filled areas of the brain (hydrocephaly); small head (microcephaly); mental retardation; eye and ear abnormalities; cleft lip and palate and heart defects.
Babies without obvious problems can develop learning disabilities, and use of the drug also increases the risk of premature delivery, miscarriage and infant death.
Accutane can cause these serious problems early in pregnancy, often before women even know they have conceived.
The drug’s risks have been publicized in the patient information included in the packaging, as well as labels on the bottles and other information. In 1998, Roche instituted a voluntary program to help prevent pregnancies during the drug’s use. Women were required to sign a consent form and have two negative pregnancy tests before they could start the drug.
Women also had to choose to reliable forms of contraception (or abstinence) for the entirety of the drug treatment plan.
Yet Julia Robertson of the Birth Defects and Genetics Program for Utah’s health department and her colleagues found that many women were not heeding the restrictions. Their study appears online in Birth Defects Research (Part A): Clinical and Molecular Teratology.
Their report followed 34 women who had taken Accutane while pregnant. The women called a voluntary hotline run by the Organization of Teratology Information Services. A teratogen is any substance – like Accutane – that causes birth defects.
Some women reported not remembering or ever hearing the old guidelines. Eight of the women didn’t remember discussing the recommended birth control options, and 25 of the 34 women never had the second pregnancy test the older guidelines suggested. And few of the women in the program were using Accutane for its intended purpose, treating nodular acne.
The study authors acknowledge its limitations: Since the hotline was only for women whose babies had birth defects, there is little information on the program’s success for women who didn’t become pregnant.
It is also possible that the small size of the study and its self-reporting mechanism might affect its accuracy.
“Nonetheless, women were surveyed prior to the outcome of the pregnancy, so we believe the responses provided in this report can be useful,” study authors wrote.
However, beginning in December 2005, the FDA will begin a collaborative program called iPLEDGE to help combat pregnancy while on Accutane. It will require all doctors and patients to register in an electronic database before the drug is prescribed. Patients must agree on two forms of birth control and take two negative pregnancy tests.
Doctors and pharmacists now play a larger role in the process as well. Not only do doctors have to register electronically, they must document the usage of the drug, issue an informed consent, and must be the ones to document the two negative pregnancy results.
Before filling women’s Accutane’s prescriptions, pharmacists must also register with iPLEDGE and check to make sure all the patient requirements have been met before they release the drug.
