Vertex Announces Boxed Warning on Hepatitis C Drug
Decision prompted by reports of fatal cases of serious skin reactions with telaprevir treatment
WEDNESDAY, Dec. 19 (HealthDay News) -- In the wake of multiple deaths, the oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning, according to a statement released Dec. 19 by Vertex Pharmaceuticals.
According to the company, in phase 3 clinical trials, serious skin reactions were experienced by less than 1 percent of those who received Incivek combination treatment. These reactions necessitated hospitalization and all patients recovered. In the post-marketing setting, some patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment had fatal cases of serious skin reactions.
Given the severity of these events and importance of discontinuing Incivek combination treatment in the case of one of these reactions, a boxed warning has been introduced to give greater prominence to this information.
"The safety of people taking our medicines is our first priority, and we are committed to ensuring that patients and physicians are aware of the label update to help them use Incivek properly," Robert Kauffman, M.D., Ph.D., senior vice president and chief medical officer at Vertex, said in a statement. "We will continue to educate physicians to follow the rash management plan developed while Incivek was in clinical trials and the information contained in the updated label."