Public area - News, events, announcments - Topic started by Gus Cairns - August 27 2009, 10:54 am

Title: Stevens-Johnson syndrome/liver failure and etravirine
Post by: Gus Cairns on August 27 2009, 10:54 am
Tibotec have issued a warnnig that cases of Stevens-Johnson syndrome have been seen with etravirine (Intelence).

From Tibotec:

Based on a review of all available safety data, Tibotec, in close
> collaboration with the health authorities, will update certain
> sections in the INTELENCE label to include additional data from post
> marketing reports and to strengthen the existing language.  Our goal
> is to educate healthcare providers so they can counsel their patients
> to ensure that use of INTELENCE is immediately discontinued and
> medical treatment is provided if severe skin and/or hypersensitivity
> reactions occur.
> In the US, the FDA has requested to add text in the Warning and
> Precautions section of the INTELENCE US label (see bottom of page 3 on
> the attached) as well as the patient counseling section (see top of
> page
> 26 on the attached) and to issue a Dear Health Care Professional
> letter.
> The new package insert and healthcare professional letter are posted
> to

> We submitted the same data to the European Health Authorities and are
> expecting a similar label change in the following weeks.

> The updates are being made as a result of additional data we have
> received from post-marketing spontaneous and clinical trial adverse
> event reporting, including two reports of toxic epidermal necrolysis
> and a separate case of hypersensitivity reaction which included
> hepatic failure.  In these reports, it was concluded that one of these
> patients died of toxic epidermal necrolysis.  These patients were also
> taking other HIV medications, in various combinations, including
> medications from the following classes:  nucleoside reverse
> transcriptase (NRTI), protease inhibitor, integrase inhibitor, fusion
> inhibitor and CCR5 inhibitor.
> Information on the potential for severe skin reactions was already
> included in the both the US labeling and EU SmPC for INTELENCE.   
> (During
> clinical development of INTELENCE, the most frequently reported
> adverse drug reaction of at least Grade 2 in severity was rash. 
> Stevens- Johnson syndrome, hypersensitivity reaction, and erythema
> multiforme were reported in less than 0.1 percent (less than one in
> 1,000) of subjects
> taking INTELENCE.)   (Mills A, et al. 17th IAC 2008. Abstract 
> TUPE0059)

And a news report:

J&J Unit Warns of Deadly Skin Reaction With HIV Drug (Update1)
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By Catherine Larkin

Aug. 26 (Bloomberg) -- Johnson & Johnson warned doctors of reports of a deadly skin reaction and liver failure tied to its HIV medicine Intelence.

The skin condition called toxic epidermal necrolysis has killed one patient and injured another since Intelence was approved in January 2008, said Pamela Van Houten, a spokeswoman for J&J’s Tibotec unit, in a phone interview today. Another patient taking the tablets reported a hypersensitivity reaction accompanied by liver failure, she said.

The prescribing information for Intelence was revised to include these reports and a caution that doctors stop treatment immediately if patients develop severe skin reactions or hypersensitivity symptoms, according to a letter e-mailed today by the U.S. Food and Drug Administration. Similar side effects were seen in some study participants and have also been linked to other drugs for HIV, the virus that causes AIDS, Van Houten said.

“We’ll continue to monitor” patient reports, she said. “We’re sending out this letter to doctors. Our sales force will also be talking to health-care providers” about the risks.

J&J, the world’s biggest maker of health-care products, didn’t disclose sales of Intelence in its annual report. The drug and Prezista, an HIV medicine approved in 2006, may bring in a combined $714 million in sales this year for the New Brunswick, New Jersey-based company, according to Glenn Novarro, an analyst with RBC Capital Markets in New York.

To contact the reporter on this story: Catherine Larkin in Washington at

Last Updated: August 26, 2009 18:19 EDT

Title: Re: Stevens-Johnson syndrome/liver failure and etravirine
Post by: Matt Williams on August 27 2009, 10:58 pm
Alas poor NNRTIs we love you well (when we're not dreaming), but your class effect of peeling people's skin from their flesh from time to time is not appreciated.