Alston, J. "Roche Defends Accutane Against New Evidence in NJ Retrial", Law360 (March 7, 2014).
Following an appellate reversal of a $10 million verdict awarded to plaintiff in 2008, lawyers for Hoffman-LaRoche Inc. defended the company in a retrial in New Jersey State court by presenting new clinical evidence that undermined claims that the drug Accutane causes inflammatory bowel disease (IBD). Roche lawyers presented the results of 6 epidemiological studies from 2009-2013, all of which showed no association between Accutane use and IBD or an inconclusive result. Plaintiff Kamie Kendall Rees claimed she was inadequately warned of a possible connection between Accutane and her ulcerative colitis. Rees began using Accutane at age 12 and was diagnosed with IBD at 15. The disease worsened, leading to the removal of her colon when she was 21. Plaintiff's lawyer argued that Roche has been aware of adverse reports about gastrointestinal distress but has failed to provide adequate warnings of the risk.
 Alston, J. "Roche Defends Accutane Against New Evidence in NJ Retrial", Law360 (March 7, 2014).
The FDA's latest watch list includes over-the-counter (OTC) acne products containing benzoyl peroxide, salicylic acid, or both because of reported hypersensitivity and anaphylactic reactions. Both agents treat acne by exfoliating dead skin cells that clog pores. In addition, benzoyl peroxide kills bacteria and salicylic acid reduces inflammation. Skin reactions and allergic reactions have been associated with both agents. Being placed on the watch list does not mean the agents actually pose the reported health risks. Rather, it means that the FDA will investigate whether there is a causal connection. If the FDA does find a causal connection, the agency would consider a response such as gathering more information, amending the drug's label or requiring a risk evaluation and mitigation strategy.
The FDA emphasizes that it is not suggesting that doctors should stop prescribing watch list drugs or that patients should stop taking the drugs. Patients who have questions should contact their health care provider. FDA is continuing to evaluate the watch listed drugs and will issue additional public communications as appropriate.
 FDA Surveillance: "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2013", 1/27/2014.