An Accutane Review
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:
- Dry skin
- Allergic reactions
- Brain swelling
- Birth defects and miscarriages
- Psychological problems
- Inflammatory Bowel Disease (IBD)
- Irritable Bowel Syndrome (IBS)
- Cardiovascular problems
- Liver problems
- Joint and muscle pain
- Lupus
- Hearing and vision damage
- Hair loss
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
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.
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 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 IBD, a condition characterized by inflammation of the intestine and tearing of the intestinal lining (ulcers). IBD actually includes multiple diseases such as:
- Crohn's Disease
- Ulcerative colitis
Severe cases can require surgery to remove portions of the colon or intestine.
In 2005, Accutane’s product label was updated to warn of risk for this serious condition.
Stricter FDA controls on Accutane acne treatment
Patients receiving Accutane must receive a Patient Medication Guide, which summarizes Accutane’s safety issues. Individuals being prescribed Accutane also must sign an Informed Consent Form acknowledging that they are aware of Accutane acne treatment risks.
In 2005, the FDA instituted a program called iPledge, requiring registration of men and women taking Accutane and placing strict controls on Accutane prescribing practices. As part of this program, women must agree to use two forms of birth control and have regular pregnancy tests while on Accutane. Pregnancy tests are also required for a month before and after Accutane treatment.
Accutane review summary
Accutane’s history has included multiple label changes as more and more serious Accutane side effects have been revealed. Accutane acne treatment requires patient education, informed consent, and regular monitoring for early detection of Accutane side effects.
If you or your loved one has suffered adverse effects from the use of Accutane, you may be entitled to compensation. We urge you to contact an experienced Accutane lawyer as soon as you can. There may be time limits by which you must commence suit.
Please contact an experienced Accutane lawyer in your area for more information.