The FDA and Accutane Warning Labels
Accutane is a prescription medication manufactured by Hoffman — LaRoche (“Roche”) to treat severe acne. In June 2009, Roche pulled Accutane from the market amid multiple lawsuits, citing economic reasons — increased competition from generic drugs – rather than safety reasons. Accutane warning labels were modified to include the risks of inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s disease, alopecia (hair loss), depression, fatigue and birth defects. Hundreds of lawsuits have been filed around the Unites States, alleging that Roche did not issue an adequate Accutane warning in the initial marketing of the drug. In one Accutane warning lawsuit that went to trial, the plaintiff recovered $25 million. The FDA created a webpage that highlights some of the Accutane warning issues. Specifically, the page details an Accutane warning for depression and birth defects.
Accutane Warning on Depression
Accutane reduces serotonin levels in patients, which causes significantly less front-lobe brain activity. The reduction in activity has caused Accutane patients to experience depression, suicidal thoughts and, on some occasions, suicide. Due to the increase in reports on suicide and depression to the FDA Adverse Event Reporting System, the agency took action and issued an Accutane warning. The FDA required a bold face Accutane warning that discloses the risk of depression. In addition, the FDA required that patients consent to the Accutane warning by signing release forms that disclose the psychological effects of the drug.
Accutane Warning on Birth Defects
- Accutane Recall
- Accutane Effects
- Accutane Injury
- Accutane Side Effects
- Accutane Ulcerative Colitis
- Accutane Birth Defects
- Accutane Depression and Suicide
- Accutane Inflammatory Bowel Disease
- Accutane Risk Management Program
- Accutane Lawsuits
- Accutane Mass Tort Lawsuits
- Accutane Lawyers
- Accutane iPledge Program
- Accutane Lawsuit
- Accutane Attorney FAQ
- Accutane Class Action Lawsuit
Dangerous Drug Alert
From 1982 to 2003, an estimated 2,000 women have become pregnant while taking the drug. Most of these pregnancies have ended in abortion or miscarriage. Many of the babies who were born are facially deformed and have been diagnosed with mental retardation. In response, the FDA required Roche to include a black box Accutane warning about birth defects in women who may become pregnant while on Accutane. As reports of birth defects continued to mount, the FDA increased its role in the Accutane warning process by setting up the iPLEDGE program in 2005. This program requires all patients who are prescribed Accutane to be registered and approved by the FDA so that the agency can monitor the effectiveness of the Accutane warning.
Accutane Warning on IBD
Additionally, Roche is currently defending nearly 5,000 lawsuits alleging that the company failed to issue an Accutane warning to patients and doctors regarding the serious risk of IBD associated with Accutane use. Since 2007, Roche has paid more than $45 million in damages to victims who suffered IBD related injuries due to Accutane use. Plaintiffs in those cases allege that Roche failed to provide an appropriate warning about the link between the drug’s use and IBD. While the FDA has not issued a formal Accutane warning for the serious IBD side effects associated with the drug, a March 2010 study published in the American Journal of Gastroenterology suggested a link between Accutane and IBD. Therefore, as information continues to surface about Accutane’s harmful side effects, lawsuits continue to mount, and the number of patients suffering from IBD as a result of their Accutane use increases, it is likely that the FDA will issue a formal Accutane warning regarding the risk of IBD.
File An Accutane Lawsuit
In recent years, numerous individuals have been harmed by Accutane. If you have experienced a serious Accutane side effect, you may be able to take legal action to recover your losses. Contact us today for a free evaluation of your potential Accutane claim.