Capecitabine (Xeloda) is a drug used to treat certain cancers. In a Dear Healthcare Professional letter dated December 3, 2013, and sent out by the drug’s maker Hoffman-La Roche, with an endorsement by Health Canada, the pharmaceutical company noted that “very rare cases of severe cutaneous reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with XELODA.”
The letter further warned that the drug should be discontinued immediately if signs of either SJS or TEN appear. Symptoms of SJS and TEN include flu-like symptoms, fever, rash, shedding of skin and/or mouth sores.
Meanwhile, the FDA has updated the warning about Onfi (clobazam), an anti-seizure medication. According to a Drug Safety Communication (12/3/13), the FDA identified 20 cases (six cases in the US and 14 worldwide) of patients developing SJS or TENS after using Onfi. Five of those in the US involved children. One of the 20 cases resulted in blindness and two resulted in death (of the two deaths, one was deemed “possibly related to Onfi,” while a link to Onfi in the other death could not be calculated).
In most of the cases of SJS or TEN reported to the FDA, the patient was taking one or more concomitant drugs associated with SJS/TEN. Although the reaction can occur at any time while taking Onfi, the FDA noted that the risk is increased during either the first eight weeks of Onfi treatment or when Onfi has been stopped and then restarted.
READ MORE STEVENS JOHNSON SYNDROME (SJS) LEGAL NEWS
The boy was then prescribed Tegretol but developed SJS, which developed into TEN. He died in March 2013. The lawsuit alleges that the behavioral health organization and its employee who prescribed the medication were negligent because Tegretol was prescribed after the boy had an allergic reaction to Lamictal, and because the mother was not warned about the potential for an additional allergic reaction.