Accutane Risk Management Program
Accutane, manufactured by Hoffman-La Roche, is a drug used for the treatment of severe acne and entered the market in 1982. Many Accutane side effects have been reported including birth defects, psychological effects, and inflammatory bowel disease (IBD). To decrease the risk of certain of these dangerous side effects, the FDA created an Accutane Risk Management Program.
FDA Strengthens Accutane Risk Management Program
The serious Accutane side effects have continued to be a source of medical and regulatory dispute. In particular, there have been reports of pregnant Accutane users miscarrying or giving birth to children with a high incidence of deformities and mental retardation. The risk of birth defects in children born to women taking Accutane during the first trimester is reported to be 30%, whereas the risk of birth defects in the general population is reported to be between 3-5%. To decrease the risk of birth defects associated with fetal exposure to Accutane, the FDA strengthened the Risk Minimization Action Plan (riskMAP) for Accutane and its generic forms (Amnesteem, Clarvis, and Sotret). To do this, the FDA now requires that prescribers of Accutane and pharmacies that dispense Accutane register with the drug companies that sponsor Accutane. Registration also includes documentation of physician and patient identification codes, a negative pregnancy test, patient education documentation, and a signed informed consent and risk management document. Although dermatologists have reported problems associated with this system, it remains as a means of ensuring that patients and physicians are properly informed about Accutane side effects in a consistent manner.
- Accutane Recall
- Accutane Effects
- Accutane Side Effects
- Accutane Birth Defects
- Accutane Depression and Suicide
- Accutane Inflammatory Bowel Disease
- Accutane Lawsuits
- Accutane Mass Tort Lawsuits
- Accutane Lawyers
- Accutane iPledge Program
- Accutane Lawsuit
- Accutane Warning
Dangerous Drug Alert
Because of these serious and life-threatening side effects, numerous victims injured by Accutane have filed Accutane lawsuits against Hoffman-La Roche seeking compensation for their injuries. Accutane lawyers have filed hundreds of Accutane lawsuits on behalf of injured individuals alleging that Accutane cased them to suffer from IBD. In one Accutane lawsuit decided in April 2008, a Florida man was awarded over $10 million in damages for inflammatory bowel disease caused by Accutane. In November 2008, in another Accutane lawsuit, three patients were awarded $13 million in damages. In that Accutane lawsuit, the jury found Roche negligent for failing to warn doctors of the potential dangers associated with Accutane. To date, seven juries in various Accutane lawsuits have found against Roche, awarding millions of dollars in damages to plaintiffs. The number of Accutane lawsuits is expected to continue to grow.
Roche Recalls Accutane
In 2009, Roche finally pulled its acne medication off the market in the United States and eleven other countries. Roche claimed that the Accutane recall was due to increased price competition from generics, and the cost of defending against Accutane lawsuits.
If you have taken Accutane and believe you have experienced Accutane side effects you may be able to file an Accutane lawsuit to recover compensation for lost wages, pain and suffering, and hospital costs. If you or a loved one has been injured by Accutane, or if you would like more information about your potential Accutane lawsuit, please contact us today.