Accutane Review
Attorneys Accepting Accutane Cases Nationwide
Accutane is a prescription medicine used to treat moderate to severe acne in people who have not had success with other acne medications.
How Accutane Treatment Works
The active ingredient in Accutane is isotretinoin, which is derived from Vitamin A. Accutane works by drying up sebum, an oily substance produced by skin glands. Too much sebum can lead to bacterial growth and inflammation of skin follicles, which in turn can lead to acne.
Accutane Side Effects
Accutane side effects are both short-term and long-term and can include:
- Inflammatory Bowel Disease (IBD)
- Crohn’s Disease
- Ulcerative Colitis
- Irritable Bowel Syndrome (IBS)
- Cardiovascular problems
- Liver problems
- Joint and muscle pain
- Lupus
- Hearing and vision damage
- Hair loss
- Dry skin
- Allergic reactions
- Brain swelling
- Birth defects and miscarriages
- Psychological problems
Some of these side effects can be quite severe and can continue even after Accutane acne treatment is stopped.
Accutane’s History of FDA Warnings and Accutane Recall
Developed in 1971 by Hoffman La-Roche (Roche), Accutane acne treatment was approved in 1982 by the Food and Drug Administration. Since then, Accutane's success as an acne treatment has been marred by a history of over twenty product labeling modifications, FDA warning letters, and litigation.
In 2009, an Accutane recall was initiated in response to the serious nature of many side effects associated with Accutane usage. In particular, the link between Accutane and the development of Inflammatory Bowel Disease, Ulcerative Colitis, and Crohn’s Disease prompted the recall.
Accutane and Birth Defects
Accutane is associated with a high rate of spontaneous abortions and birth defects. In 1985, the FDA required Roche to add a black box warning to its label advising that Accutane should not be used by pregnant women and that all women taking Accutane should be using contraceptives.
Accutane-associated birth defects include:
- Hearing and visual impairment
- Facial deformities
- Mental retardation
- Heart defects
- Brain abnormalities
Accutane and Psychological Side Effects
Accutane acne treatment has been associated with:
- Depression
- Suicidal thoughts, risk for suicide, and suicide attempts
- Psychosis
Increased aggression and violent behavior can also occur with Accutane use, especially in men.
From 1985 through 2005, there have been increasingly stronger label warnings of the association between Accutane acne treatment and mental illness. Some have alleged that Roche did not respond in a timely manner to evidence of psychological problems associated with Accutane. In 1997, Roche was required by French regulatory authorities to list suicide as a potential side effect of the drug, but the company did not alert the FDA. In the same year, the FDA issued a warning letter to Roche for allegedly failing to report side effects promptly. In 1998, the FDA sent another warning letter to Roche, alleging false and misleading advertising that downplayed Accutane's "negative psychosocial effects."
Accutane and Inflammatory Bowel Disease (IBD)
Accutane also has been associated with Inflammatory Bowel Disease (IBD), a condition characterized by inflammation of the intestine and tearing of the intestinal lining (ulcers). IBD actually includes multiple diseases such as:
Severe cases can require surgery to remove portions of the colon or intestine.
Accutane Lawsuits
If you or your loved one has suffered adverse effects from the use of Accutane, you may be entitled to compensation. The attorneys at Hagens Berman have handled several high profile pharmaceutical injury claims, including cases against the makers of Vioxx and Celebrex. We have the vast resources of a large national law firm, and we can help you receive the compensation you deserve.
Please contact our Accutane lawyers today to schedule your free initial consultation. Hagens Berman serves clients nationwide.
