FDA Strengthens Accutane Risk Management Program
May 1, 2010
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). 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. Dermatologist have reported having problems with this system but at least it is a way of making sure that patients and physicians are properly informed about Accutane side effects in a consistent manner.
Roche Recalls Accutane:
In April 2008, a Florida man was awarded over $10 million for suffering with Inflammatory Bowel Disease (IBD) caused by Accutane. In November 2008, three patients were awarded $13 million in damages that had developed into IBD. The jury found Roche was negligent in informing doctors of the potential dangers associated with Accutane. To date, seven juries have found against Roche, awarding millions of dollars in damages to plaintiffs.
In 2009, Roche finally pulled its acne medication off the market in the United States and eleven other countries. Roche says they recalled Accutane because of price competition from generics.
If you have taken Accutane and believe you have experienced Accutane side effects you may be entitled to compensation for lost wages, pain and suffering, and hospital costs. You might want to contact a lawyer about the Accutane recall to see if you qualify for a lawsuit.
Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research. Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising. To learn more about Accutane side effects or Accutane Recall please visit www.ConsumerInjuryLawyers.com