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.

[quayle]

I should clarify my statement the article was a newspaper article,by a journalist and to terrify people with less than 1% danger is like saying look both ways before crossing the road there has been no official statement made by the manufacturer that I've seen,just a journo hyping a fact that was pretty much already realized.And if anyone taking  any new drug for Hep C there are many things yet to know from all of them,I don't know about anyone else on tx but I've disclaimed all effects including Death from the clinic that is treating me,so If you don't want to do the time don,t do the crime,and as soon as you have clinical scientific research that,is more than a journalists hyp let me Know.

[hrsepwrguy]

Hep C Drug Linked to Fatal Skin Reactions

By John Gever, Senior Editor, MedPage Today
Published: December 19, 2012

http://www.medpagetoday.com/InfectiousDisease/Hepatitis/36528

[hrsepwrguy]

WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. 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.

http://pi.vrtx.com/files/uspi_telaprevir.pdf

[quayle]

Could Hector please inform us as to the exact source of his information so that we may read it ourselves to make our own determination,please inform us of links articles research and such.

[can-do-man]

"The likelihood of all patients having the full support of all the specialists they need is low, so, once again it falls to the patient to educate themselves in order to make informed decisions."

So true!

[desrt]

"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"

"For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately."


Less than 1% is comparable to the black box warning for fatal psych events from IFN alpha. The problem I see is doctors not experienced with what constitutes "systemic symptoms" or "progressive severe rash" being quick to pull patients off tx and creating resistant strains of the virus. For safe, effective tx, you now need another specialist, since occurance of non-fatal rash is way higher than 1%.

So:

gastro or hepatologist
hematologist
dermatologist
psychiatrist

The likelihood of all patients having the full support of all the specialists they need is low, so, once again it falls to the patient to educate themselves in order to make informed decisions.