Although it is an effective treatment for cystic acne, Accutane related birth defects are extremely common in pregnant women taking the medication. In fact, the FDA has found a 25 to 35 percent increase in risk for severe abnormalities while taking the drug. The U.S., Germany and Australia are among the countries that have produced positive evidence for its dangers, and it has earned an ‘X’ designation from the FDA. This means that it is among the substances most likely to cause deformities.
The active ingredient in the drug, isotretinoin, is associated with severe drug side effects, including Accutane-related birth defects, due to its molecular similarity to retinoic acid. Retinoic acid is a vitamin A derivative that is critical for embryonic development. When isotretinoin interferes with the development process, it keeps retinoic acid from doing its job, which is to set embryonic positioning in the womb. Deformities caused by the medication include vision and hearing loss, missing earlobes, facial dysmorphism, mental retardation and more. Between 1982 and 2003, around 2,000 women became pregnant while taking the substance, and most pregnancies ended in either abortion or miscarriage. Of those that were able to carry to term, there were deformities in nearly 160 births.
In 2005, the FDA created the iPLEDGE program to keep pregnant women from taking the drug. The only doctors that can prescribe the medication are those that are registered with iPLEDGE. Patients receiving Accutane must also be registered with iPLEDGE. The idea is to rein in the distribution of this drug and to monitor its usage closely in an effort to protect patients.