Accutane Birth Defects

Accutane® (isotretinoin) is a powerful medication that was designed to treat severe nodular acne until it was recalled from the market in June 2009. The manufacturer, Roche Laboratories said it was pulling the drug from the market because of financial problems. Many patients who used Accutane® have sued the company for damages they say resulted from using the acne medication.

Accutane® and Birth Defects

The drug has been reported to have many severe Accutane® side effects. Among the most well known of these are birth defects. Fetuses of women taking Accutane® early in their pregnancy are at extremely high risk of being born with malformations, including:

  • Severe heart defects
  • Hydrocephaly (enlargement of fluid-filled spaces in the brain)
  • Microcephaly ( small head and brain)
  • Mental retardation
  • Abnormalities of the eyes and ears
  • Cleft lip, palate, and other facial abnormalities

Some babies have been stillborn.

Accutane® Regulations

The U.S. Food and Drug Administration (FDA) and the drug company initiated a program called iPledge, a drug distribution program to help prevent pregnant women or female patients of childbearing age from taking the medication. A female patient is required to have a pregnancy test before being prescribed the drug and had to pledge they would use two forms of contraception while taking Accutane®.

Accutane® Side Effects: Bowel Problems

Accutane® has also been associated with severe damage to patients' bowels and colon, including the development of intestinal disorders such as Crohn's disease, Ulcerative Colitis and inflammatory bowel disease. Symptoms may include severe stomach pain, heartburn, diarrhea and rectal bleeding.

Other Serious Side Effects of Accutane®

Other potential side effects include:

  • Severe skin problems
  • Problems of pressure upon the brain that lead to blindness
  • Severe headache, seizures, stroke, vomiting and nausea
  • Problems with blood glucose that put a patient at risk of diabetes
  • Bones that are prone to breaking
  • Permanent loss of hearing
  • Increase in lipids and cholesterol
  • Swelling of the face and mouth

Compensation May be Available

If you or someone you know has suffered any of these serious side effects and has a history of using Accutane®, you may be eligible to collect damages from the manufacturer. To discuss your specific circumstances with a legal professional, contact our Accutane® recall lawyers today. We provide FREE consultations to prospective clients.