Generic: Isotretinoin, a synthetic form of Vitamin A
Approved to treat: Severe acne
Drug category: Acne medication
Year approved: 1982
Manufacturer: Hoffman La-Roche
Babies who are prenatally (before birth) exposed to Accutane have a 30 percent increased risk of developing birth defects, including:
- Hearing impairment
- Missing earlobes
- Visual impairment
- Facial malformations
- Heart defects
- Mental retardation
- Glandular malformations
- Malformations of the central nervous system
FDA Warnings and Recalls
In March 2007, the U.S. Food and Drug Administration (FDA) notified consumers and healthcare professionals that Accutane must be used only for treatment of severe, scar-forming acne that does not respond to other forms of treatment. If the drug is improperly used, the FDA warns, it can cause severe side effects including serious birth defects.
In addition, the FDA also established a special program called the iPledge Program to protect women and unborn children from Accutane side effects. This iPledge program basically requires that women seeking Accutane prescriptions register for the program and sign agreements to use birth control and undergo pregnancy testing before, during or after taking Accutane. Because of the serious risks, patients must also read all program brochures and agreements and sign a risk management document.
Roche recalled Accutane on June 26, 2009, pulling the dangerous drug from the United States and other markets. Roche is currently facing hundreds of Accutane birth defect lawsuits.