Hep C Drug Linked to Fatal Skin Reactions - less than 1% of patients

[HectorSF]

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.

[hrsepwrguy]

"You just simply can't feel it, cause you haven't been there."

But I have treated and I didn't try to minimize or maximize the %'s, only point out where the maker had changed their packaging and share my personal experience with someone who hasn't started treatment yet, not everyone has every side effect, so what is your point.

[Diana66]

yes, some antibiotics can cause liver failure and some are very hepatotoxic

http://jac.oxfordjournals.org/content/early/2011/05/17/jac.dkr159.full

[rambleon40]

"I treated with incivek/peg/riba for 48 wks and never got a rash, it's clear you just want to argue, so I will step out of the conversation."

that's wonderful!

It might be really hard for you to understand or empathize with those many who did not have the smooth sailing you did.  You just simply can't feel it, cause you haven't been there.

[rambleon40]

The warnings utterly lack any % likelihood, and simply naming a syndrome does little to impart the nature of its afflictions upon the layman's brain.  This is especially true when everything starts off with "you're likely to feel flu like symptoms and fatigue"

The warnings on all the INF drugs fail to state that if you suffer one bad side effect, you are likely to suffer a number of them.  

The seller almost always knows the product better than the buyer.  

Caveat emptor, for sure.

[orphanedhawk]

Who told you antibiotics could cause hepatic failure ?
I've never heard of such a thing.
After my liver transplant I was put onto antibiotics for several weeks.
Perhaps you're thinking of analgesic meds such as tylenol ?

[can-do-man]

Whats your response to me have to do with what I said???