| FDA Strengthens Accutane Risk Management | | | | risk management document. Dermatologist have |
| Program: | | | | reported having problems with this system but at |
| | | | | least it is a way of making sure that patients and |
| Accutane, manufactured by Hoffman-La Roche, is a | | | | physicians are properly informed about Accutane side |
| drug used for the treatment of severe acne and | | | | effects in a consistent manner. |
| entered the market in 1982. Many Accutane side | | | | |
| effects have been reported including birth defects, | | | | Roche Recalls Accutane: |
| psychological effects, and Inflammatory Bowel | | | | |
| Disease (IBD). Accutane side effects have | | | | In April 2008, a Florida man was awarded over $10 |
| continued to be a source of medical and regulatory | | | | million for suffering with Inflammatory Bowel Disease |
| dispute. In particular, there have been reports of | | | | (IBD) caused by Accutane. In November 2008, |
| pregnant Accutane users miscarrying or giving birth | | | | three patients were awarded $13 million in damages |
| to children with a high incidence of deformities and | | | | that had developed into IBD. The jury found Roche |
| mental retardation. The risk of birth defects in | | | | was negligent in informing doctors of the potential |
| children born to women taking Accutane during the | | | | dangers associated with Accutane. To date, seven |
| first trimester is reported to be 30%, whereas the | | | | juries have found against Roche, awarding millions of |
| risk of birth defects in the general population is | | | | dollars in damages to plaintiffs. |
| reported to be between 3-5%. To decrease the | | | | |
| risk of birth defects associated with fetal exposure | | | | In 2009, Roche finally pulled its acne medication off |
| to Accutane, the FDA strengthened the Risk | | | | the market in the United States and eleven other |
| Minimization Action Plan (riskMAP) for Accutane and | | | | countries. Roche says they recalled Accutane |
| its generic forms (Amnesteem, Clarvis, and Sotret). | | | | because of price competition from generics. |
| To do this, the FDA now requires that prescribers of | | | | |
| Accutane and pharmacies that dispense Accutane | | | | If you have taken Accutane and believe you have |
| register with the drug companies that sponsor | | | | experienced Accutane side effects you may be |
| Accutane. Registration also includes documentation | | | | entitled to compensation for lost wages, pain and |
| of physician and patient identification codes, a | | | | suffering, and hospital costs. You might want to |
| negative pregnancy test, patient education | | | | contact a lawyer about the Accutane recall to see if |
| documentation, and a signed informed consent and | | | | you qualify for a lawsuit. |