Two months after the FDA issued a safety alert informing about the serious skin reactions, some fatal, in patients taking Vertex Pharmaceuticals Inc.'s (VRTX) hepatitis C drug Incivek, it is now Health Canada's turn to alert health-care providers and patients.
A public advisory issued by Health Canada on Feb.27, 2013, states that Incivek, which is always used in combination with two other drugs - Peginterferon alfa and Ribavirin, has been found to be associated with serious skin reactions.
The Incivek combination treatment has resulted even in death, warns Health Canada.
Patients taking Incivek combination treatment are requested to consult a physician right away if they develop any of the following skin changes like blisters or ulcerations, swelling of face, rash, with or without itching, mouth sores or ulcers, red or inflamed eyes, like "pink eye" (conjunctivitis), or fever, as they may be a sign of a serious skin reaction, says the advisory.
Last December, the FDA added a Black Box Warning for Incivek after reports of fatal skin reactions were linked to the drug.
Incivek was approved by the FDA in May 2011 and by Health Canada in August 2011 for people with hepatitis C.
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