A program designed to prevent women from becoming pregnant while taking the popular acne drug, isotretinoin (Accutane) may not be effective. A new study suggests guidelines are not being consistently followed.
In 1998, the U.S. Food and Drug Administration and Roche Pharmaceuticals developed a program to prevent conception in women taking the drug, as its use in pregnancy is associated with birth defects.
Free Accutane Case EvaluationThe study included 34 women who had contacted a birth defect information service about the effects of isotretinoin. Of the women, 24 percent reported receiving contraception counseling while taking the drug. According to the requirements, women must have two negative pregnancy tests before receiving the drug, however, 76 percent of the women in the study reported not having a second pregnancy test. Thirty-five percent reported not having required monthly pregnancy tests. While taking the drug, women are required to use two forms of birth control. Among the study participants, only 62 percent of the women reported using birth control.
The authors acknowledge the study's limitations including the small number of women surveyed and the fact that the responses are based on patient self-reporting. "Nonetheless, women were surveyed prior to the outcome of the pregnancy, so we believe the responses provided in this report can be useful," the authors say. Beginning in December 2005, new regulations will require doctors and patients to register in an electronic database before the drug can be dispensed. The plan also includes two pregnancy tests, two birth control methods and other previously recommended safeguards.
On August 12th the FDA announced that starting December 31, 2005, thousands of Accutane users, plus the doctors who prescribe it and stores that sell it, must enroll in a national registry that ensures they understand all the drug’s risks, and take special steps to avoid the most notorious one, Accutane-damaged pregnancies.
If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities. The drug may also trigger or worsen depression or suicidal thoughts, according to a warning on the pills’ label that the FDA strengthened Friday and that patients are to receive as part of the new program.
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