Accutane is a prescription drug that doctors prescribe to treat severe cases of acne, a common skin disease. The drug is manufactured in the U.S. by Hoffmann-La Roche, Inc. ("Roche") and was approved by the United States Food and Drug Administration (FDA) in 1982. For many years, Accutane has been known to cause birth defects when used by pregnant women. Others claim that Accutane is an unsafe drug that has led to depressive and suicidal behavior.
What are the Birth Defect Risks Associated with Accutane?
There are particular risks that have been linked to Accutane. As stated above, one such risk is the possibility of birth defects. Despite a warning label on Accutane, birth defects caused by the drug nevertheless occurred. Some birth defect risks include:
- Hydrocephaly (enlargement of fluid-filled spaces of the brain);
- Microcephaly (small head);
- Heart defects;
- Facial deformities (i.e. cleft lip, missing ears);
- Mental retardation;
- Possible learning disabilities not detectable at birth;
- Miscarriages/Premature births.
Roche has taken steps to prevent pregnancies during Accutane treatment, but women who took Accutane still became pregnant, causing the FDA to require Roche to make further labeling changes.
Are there any Mental/Emotional Risks?
Many lawsuits have been filed claiming that the use of Accutane led to depression or suicidal behavior in some patients. The FDA has received numerous complaints linking Accutane to depression, suicidal ideation (thoughts of suicide), and suicide attempts. However, there has been no clear scientific evidence indicating a link between Accutane and depression.
Do I Need to Consult with Specialized Accutane Lawyers if I Have Been Harmed by Accutane?
Recovering damages for Accutane related injuries can be very difficult. An experienced products liability attorney can help you prepare the necessary paperwork and file a lawsuit on your behalf.