Vertex to Put Allergy Warning on Drug Incivek’s Label

Vertex to Put Allergy Warning on Drug Incivek’s Label

It was in 2011 that Vertex Pharmaceuticals Inc. got permission from the FDA to sell its first solely developed drug Incivek. The health regulators allowed the drug to be taken along two other hepatitis C treatments peginterferon alfa and ribaviran.

Except US, the drug is also sold in Japan, Canada, and Europe and in some countries of South America. Everything was going well, but then the FDA got the news of two death reports due to severe skin infection. The skin infection took place due to consumption of the drug with other two hepatitis C treatments.

Therefore, it has now been ordered by the FDA that Vertex has to put the strictest warnings of the FDA to gain attention of people, who buy the drug. The warning in a black box will warn people about the possibility of skin rashes due to the drug.

It will also inform them to take medical help when the drug taken in combination with other two hepatitis C treatments. The drug manufacturer said that side effect can range from skin allergy, fever, mouth sores and diarrhea.

One of the deaths has taken place in Japan and the other death has taken place in the United States, said the FDA officials.



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