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Hep C Drug Linked to Fatal Skin Reactions - less than 1% of patients
Hep C Drug Linked to Fatal Skin Reactions
By John Gever, Senior Editor, MedPage Today
Published: December 19, 2012
The oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning about potentially fatal skin reactions in the wake of multiple deaths, its manufacturer said Wednesday.
According to a statement from Vertex Pharmaceuticals, "Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serious skin reaction was identified."
The new warning stresses that combination treatment with telaprevir should be stopped immediately in patients with serious skin reactions, such as rashes with systemic symptoms or progressive severe rashes. Discontinuation of other drugs with the potential for skin reactions also should be considered.
Serious skin reactions were seen during the drug's clinical trials prior to approval, including some requiring hospitalization and considered life-threatening. The risk was noted on telaprevir's original label.
But these events were rare -- affecting less than 1% of patients -- and all patients eventually recovered, Vertex said.
The reports of deaths associated with skin reactions emerged during postmarketing surveillance. The company did not indicate how many fatalities were reported.
"Given the severity of the events reported in the postmarketing setting, and the importance of discontinuing Incivek combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning," Vertex said.
It also said the telaprevir label had been modified with new information on the time to onset of anemia and on its management.
The drug, a hepatitis C virus protease inhibitor, was approved in May 2011.
By John Gever, Senior Editor, MedPage Today
Published: December 19, 2012
The oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning about potentially fatal skin reactions in the wake of multiple deaths, its manufacturer said Wednesday.
According to a statement from Vertex Pharmaceuticals, "Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serious skin reaction was identified."
The new warning stresses that combination treatment with telaprevir should be stopped immediately in patients with serious skin reactions, such as rashes with systemic symptoms or progressive severe rashes. Discontinuation of other drugs with the potential for skin reactions also should be considered.
Serious skin reactions were seen during the drug's clinical trials prior to approval, including some requiring hospitalization and considered life-threatening. The risk was noted on telaprevir's original label.
But these events were rare -- affecting less than 1% of patients -- and all patients eventually recovered, Vertex said.
The reports of deaths associated with skin reactions emerged during postmarketing surveillance. The company did not indicate how many fatalities were reported.
"Given the severity of the events reported in the postmarketing setting, and the importance of discontinuing Incivek combination treatment in the event of one of these reactions, the information has been given greater prominence through a boxed warning," Vertex said.
It also said the telaprevir label had been modified with new information on the time to onset of anemia and on its management.
The drug, a hepatitis C virus protease inhibitor, was approved in May 2011.
WARNING: SERIOUS SKIN REACTIONS
Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVEK combination treatment [see Warnings and Precautions (5.1)]. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.
...The presenting signs of DRESS may include rash, fever, facial edema, and evidence of internal organ involvement (e.g., hepatitis, nephritis). Eosinophilia may or may not be present. The presenting signs of SJS may include fever, target lesions, and mucosal erosions or ulcerations (e.g., conjunctivae, lips).
THis is from the letter to physicians on Vertex' website
Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVEK combination treatment [see Warnings and Precautions (5.1)]. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.
...The presenting signs of DRESS may include rash, fever, facial edema, and evidence of internal organ involvement (e.g., hepatitis, nephritis). Eosinophilia may or may not be present. The presenting signs of SJS may include fever, target lesions, and mucosal erosions or ulcerations (e.g., conjunctivae, lips).
THis is from the letter to physicians on Vertex' website
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