There have been numerous links to Accutane side effects in pregnant women. Females who are on Accutane during their pregnancy risk serious birth defects, including severe brain and heart defects, mental retardation, as well as other risks.
Accutane Lawsuit Update 7/2/12: Last month, pharmaceutical giant Roche Holding AG was ordered to pay a total of $18 million to settle a pair of lawsuits claiming that Accutane caused the plaintiffs’ inflammatory bowel disease (IBD). The company has now lost nine of 13 lawsuits brought by former Accutane users that have gone to trial since April 2007. Click here to learn more.
What’s the problem?
When the U.S. Food & Drug Administration (FDA) approved Accutane, the drug was known to be teratogenic–able to cause birth defects. It was designated as Category X, meaning that it must be avoided under all circumstances during pregnancy. Nursing mothers also should not use Accutane. Though not every fetus exposed to Accutane becomes deformed, the risk of birth defects among pregnant women is extremely high.
Accutane Birth Defects Among Pregnant Women
Birth defects among pregnant women associated with Accutane use include (but are not limited to):
- hydrocephaly (enlargement of the fluid-filled spaces of the brain)
- heart defects
- microcephaly (small head)
- facial deformities such as cleft lip and missing ears
- mental retardation
Since first becoming available to the public, the FDA has received well over 2,000 reports of Accutane pregnancy; however, the actual number is believed to be much higher due to underreporting. Also, this is due to the fact that doctors are not required to report Accutane linked pregnancies to the FDA.
the FDA is currently debating guidelines for tighter restrictions that could finally reduce the Accutane pregnancy and birth defects numbers. It is widely believed that photographic evidence of severe cystic acne and proof that the patient has not responded to other acne medications should be required. In addition, women should have a written statement detailing their contraceptive practices and be able to show negative pregnancy tests.