Geoff Campbell, who has Hep C, was waiting for Incivek to be approved in Ontario
A chronic Hepatitis C wonder drug that has caused death and serious skin reactions has been hit with a serious warning and alert by Health Canada, two months after the same urgent message in the U.S. The Incivek capsules are the flagship product of Vertex Inc., a Massachusetts pharmaceutical company with a branch in Laval, Que.
Health Canada warned people to seek “urgent” medical treatment if they develop a serious skin reaction while taking Incivek, the trademark name of the drug teleprevir produced by Vertex Pharmaceuticals Canada Inc. Deaths have occurred in people with “progressive rash and systemic symptoms” who kept using the drug, Health Canada said Wednesday. The U.S. parent company announced the “black box” warnings, the highest cautionary level, in December. The drug was approved in the U.S. and Canada in 2011.
Health Canada’s longer process for issuing such warnings caused the extra two-month lag in announcing the complications, Vertex U.S. spokeswoman Erin Emlock told the Star. “We had to work through that process” with Health Canada, she said. “There are a limited group of physicians who prescribe the drug in Canada. There are many, many more patients in the U.S.,” she said. In December, the U.S. Federal Drug Administration said there had been two deaths and 112 serious skin reactions. Emlock said she didn’t know if any of those were in Canada. Ontario doctors last fall questioned why it was taking the province so long to approve the drug. “The medication can dramatically shorten the treatment time for hep C, limiting the impact of side effects like anemia and rashes, and it has been shown to cure the condition in a majority of new cases,” the Star’s Rob Ferguson reported.
Provincial drug plans in Quebec, Nova Scotia, New Brunswick, Alberta, B.C. and the Yukon and private insurers were paying for the $35,000 cost of a standard 12-week treatment, Ferguson reported. Health Canada advised patients to talk to their doctors before they stop using the medication. “Fatal and non-fatal serious skin reactions, including Toxic Epidermal Necrolysis (TEN), Stevens Johnson Syndrome (SJS), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients receiving Incivek combination treatment,” Health Canada said.
Incivek is used only in combination with peginterferon alfa and ribavirin. At the time of the Health Canada approval, Canadian Incivek investigator Dr. Eric Yoshida of the University of British Columbia said, “Incivek has been shown to help clear the virus for nearly four out of five patients new to treatment.” Vertex chief medical officer Robert Kauffman said a quarter of a million Canadians suffered from Hepatitis C. The drug is used to treat genotype 1 chronic hepatitis C in adult patients with compensated liver disease.