Hepatitis C drug, Incivek, linked to fatal skin reactions
Incivek
Image/Vertex Pharmaceuticals-Business Wire
Cambridge, MA company, Vertex Pharmaceuticals Inc, announced Wednesday that hepatitis C drug, Incivek (generic: telaprevir) has received a black boxed warning in the US to warn patients of the risk of fatal and non-fatal serious skin reactions, according to a Vertex press release Dec. 19.
This comes after at least two patients died after developing severe skin rashes while taking Incivek according to the US Food and Drug Administration (FDA).
According to Vertex, rash and serious skin reactions are known adverse events associated with INCIVEK combination treatment and were previously included in the warnings and precautions section of the label. Given the severity of the events reported in the post-marketing 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.
Incivek (telaprevir) tablets is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. It is taken in combination with pegylated-interferon and ribavirin. The drug received FDA approval in May 2011.
According to the FDA approval press release dated May 23, 2011, “The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain. Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.”
Vertex Pharmaceutical Senior VP and Chief Medical Officer, Robert Kauffman, M.D., Ph.D., “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.
“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.”
According to the U.S. Centers for Disease Control and Prevention, about 3.2 million people in the United States have chronic hepatitis C, a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Hepatitis C is a contagious liver disease that results from infection with hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C is usually spread when blood from a person infected with hepatitis C virus enters the body of someone who is not infected. It is rare to see it transmitted via organ and tissue transplantation.
Hepatitis C can be either “acute” or “chronic”. Acute hepatitis C virus infection is a short-term illness that occurs within the 1st 6 months after someone is exposed to hepatitis C virus. For most people, acute infection leads to chronic infection. Chronic hepatitis C is a serious disease than can result in long-term health problems, or even death. There is no vaccine for hepatitis C.
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