Delaware’s Injury & Medical Malpractice Leaders


Accutane is an acne medication manufactured by Hoffman-La Roche, Inc., for the treatment of moderate to severe acne that is resistant to topical creams or antibiotics. Accutane is a synthetic form of Vitamin A and has been used by more than 16 million people worldwide, mainly teenagers and young adults. In 2005, the FDA revised Accutane‘s warning label to warn against the increased risk of depression and suicidal tendencies.

The FDA also enacted measures to ensure that the medication is not used by pregnant women through the creation of a national registry, iPLEDGE, to encourage pregnant women not to take Accutane. Accutane presents such high risks during pregnancy that all female users are required to enroll in iPLEDGE, stating that they are aware of the drug’s serious potential risks to their babies, which include mental retardation, severe brain and heart defects. Women must agree to use at least two forms of birth control while taking Accutane and undergo a doctor-performed pregnancy test prior to taking Accutane and monthly pregnancy tests thereafter. iPLEDGE was created to encourage pregnant women not to take Accutane.

An increasing number of serious health-related conditions have been reported to the FDA which include the following:

  • Depression
  • Suicidal Tendencies
  • Mood Changes
  • Loss of Vision
  • Stroke
  • Abdominal, Liver and Intestinal Problems
  • Inflammatory Bowel Disease
  • Crohn’s Disease
  • Ulcerative Colitis
  • Ulcers/Bleeding
  • Mental Retardation (Babies)
  • Severe Brain/Heart Defects (Babies)
  • Hearing Problems
  • Yellowing of the Skin and Eyes
  • Severe Stomach Pain
  • Vomiting
  • Weight Loss
  • Seizures
  • Slow or Difficult Speech

Contact your doctor immediately if you are taking Accutane and experience any serious side effects or health conditions.

If you, your loved one, or your baby suffered a serious health condition as a result of the use of Accutane, please contact our office today for a FREE consultation at 302-298-0370.