Treatment News : FDA Gives Hep C Drug Incivek 'Black Box' Warning for Causing Fatal Skin Reactions

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join

Back to home » Treatment News » December 2012

Most Popular Links
Most Popular Lessons

The HIV Life Cycle


Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

20 Years Ago In POZ

More Treatment News

Click here for more news

Have news about HIV? Send press releases, news tips and other announcements to


December 19, 2012

FDA Gives Hep C Drug Incivek 'Black Box' Warning for Causing Fatal Skin Reactions

Vertex Pharmaceuticals’ hepatitis C antiviral Incivek (telaprevir) has caused two deaths due to serious skin reactions, The Boston Globe reports. Consequently, the U.S. Food and Drug Administration (FDA) has given the drug its most severe “black box” warning, alerting consumers to both fatal and nonfatal serious skin reactions.

One of two FDA-approved protease inhibitors available for use in triple combination therapy with interferon and ribavirin to cure hepatitis C virus (HCV), Incivek caused skin reactions in less than 1 percent of those taking the antiviral in Phase III clinical trials. Some of those study participants were subsequently hospitalized, but there were no fatalities. This is the first report of deaths from the drug. Vertex urges anyone who has a skin reaction to stop treatment immediately, as the two who have died continued therapy after identifying the reaction.

To read the Boston Globe report, click here.

To read the Vertex statement, click here.

Editor's Note: A previous version of this article stated Vertex had not yet disclosed the number of deaths due to Incivek.  The article has since been updated to reflect the number of fatalities is two.

Search: Hepatitis C, HCV, hep C, Vertex, Incivek, telaprevir, U.S. Food and Drug Administration, FDA, black box warning, fatal, death, skin reaction, interferon, ribavirin, Phase III clinicial trials

Scroll down to comment on this story.


(will display; 2-50 characters)


(will NOT display)


(will display; optional)

Comment (500 characters left):

(Note: The POZ team reviews all comments before they are posted. Please do not include either ":" or "@" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules

Hide comments

Previous Comments:


[Go to top]

Facebook Twitter Google+ MySpace YouTube Tumblr Flickr Instagram
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar
POZ on Twitter

Ask POZ Pharmacist

Talk to Us
Has a pet helped you deal with your HIV?


more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2016 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.