Accutane and Birth Defects
The anti-acne prescription drug Accutane (isotretinoin) has been linked to a number of serious side effects that may threaten your quality of life. Not only has Accutane reportedly caused inflammatory bowel diseases like Crohn’s disease or ulcerative colitis, but it has also been linked to a number of devastating birth defects. Professionals have known about the risk of birth defects since Accutane was first introduced in 1982. This is because the isotretinoin molecule is very close to that of retinoic acid, a derivative of Vitamin A that controls the development of the human embryo. In most cases, isotretinoin causes miscarriages or still births, and birth defects for babies that do survive.
Statistics report that between 1982 and 2003, approximately 2,000 women got pregnant while taking Accutane. Of these pregnancies, the majority of them ended in either an abortion or miscarriage and 160 of the children were born with a birth defect. When Accutane was first introduced, it was intended to be a last resort treatment for patients suffering from a severe case of acne where other treatment options did not work. Unfortunately, doctors began prescribing it to millions of patients, including pregnant women. Because of these side effects, Accutane is no longer sold in the United States, but many parents are still suffering from its harmful effects. Types of Birth Defects With this high risk of birth defects, the FDA required Hoffman-La Roche to place warnings on Accutane labels, and has even made them revise the label a number of times. Before it was pulled from the market in 2009, Accutane went before the FDA over twenty different times before it finally received a black box warning – the highest possible warning from the FDA. Along with an extreme risk of spontaneous abortion and miscarriages and premature births, babies that are born are at risk of the following birth defects:
Any of the above birth defects can be devastating to your child and entire family. If your child has suffered a birth defect because of Accutane, he or she may not live up to their full physical or mental potential. Preventing Birth Defects To help decrease and eliminate the risk of birth defects, the FDA created a number of requirements for women taking Accutane. These include registering with the federal iPLEDGE program with verified proof of participation, as well as proof the woman is using birth control and also has negative pregnancy test results on a regular basis. Accutane manufactures also recommend that women taking Accutane should use two forms of contraception simultaneously at least a month before beginning treatment and one month after ending treatment. Although Accutane is no longer available in the United States, it can still be purchased outside of the country or online and illegally shipped to the United States. |