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Accutane and Birth Defects

WARNINGS: Accutane must not be used by females who are pregnant. Although not every fetus exposed to Accutane has resulted in a deformed child, there is an extremely high risk that a deformed infant can result if pregnancy occurs while taking Accutane in any amount even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining, after Accutane exposure, which fetus has been affected and which fetus has not been affected.

Accutane has been associated with severe birth defects in children whose mothers were taking Accutane before or during pregnancy. There is an extremely high risk that a baby will be deformed or will die if the mother is pregnant while taking Accutane.

The risk of birth defects in children whose mother's underwent Accutane treatment during pregnancy is considered so high that terminating pregnancy is considered the only solution.

In addition to birth defects Accutane can also cause miscarriage, premature birth or death of the baby.

Birth defects may include:

  • Skull abnormalities

  • Ear abnormalities

  • Eye abnormalities

  • Facial dysmorphia

  • Cleft palate

  • Cerebral abnormalities

  • Cranial nerve deficit

  • Cardiovascular problems

  • Death

Women MUST NOT get pregnant while undergoing treatment with Accutane. Many safe guards have been set in place to prevent pregnancy during Accutane treatment, but ultimately it is up to the individual to decide if they want to risk becoming pregnant while taking Accutane.

If a woman decides to begin treatment with Accutane she must first submit two negative pregnancy tests prior to starting treatment. Once treatment has begun she must submit a negative pregnancy test to her physician once a month and use 2 methods of birth control during treatment. A woman must not become pregnant for 1 month after using Accutane, as their still may be traces of the drug in her system that would cause severe birth defects.

So far birth defects have been the most severe and controversial side effects of Accutane. The controversy is exacerbated even more because abortion is considered the only option for women who conceive during Accutane treatment. The risk of severe and life threatening birth defects is that high. The birth defect disaster associated with Accutane has been compared to the tragedy of Thalidomide births in the 50's and 60's.



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