Robert J. Boumis  |  November 21, 2014

Category: Legal News

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Incivek A recent Quarter Watch report from the Institute for Safe Medicine Practices (ISMP) indicates that the hepatitis C treatment Incivek (telaprevir) should be “carefully considered” when deciding whether it should remain on the market due to the high number of hypersensitivity reactions reported among users.

The May 2014 ISMP QuarterWatch report, which uses FDA data to alert medical professionals about the possible risks associated with drugs on the market, found that Incivek was among the top two drugs most commonly associated with hypersensitivity reactions such as Stevens Johnson Syndrome.

Stevens Johnson Syndrome or SJS is a severe reaction, often to medication, in which the immune system goes haywire and attacks the body, treating the skin like an invading disease-causing germ. SJS symptoms include a blistering skin rash that gives way to sores and ulcers. The damage from SJS can spread to the eyes and internal organs. While Stevens Johnson Syndrome is often lethal, even survivors face a lifetime of complications like disfiguring and disabling scarring, blindness, and impaired organ function.

The most severe cases of SJS can escalate to a related disorder called Toxic Epidermal Necrolysis or “TEN” for short. Patients with TEN face even more severe SJS symptoms, like patches of skin dying and sloughing off, leaving wounds similar to thermal burns. Patients with TEN have a 30% to 40% mortality rate, while SJS can range up to 30% depending on the severity.

ISMP Report Findings

ISMP analyzed computer excerpts from the FDA Adverse Event Reporting System and screened 147,318 selected cases of serious adverse drug events reported to the FDA from March 2012 through March 2013.

Hypersensitivity was very common and accounted from more cases than any other among the 91 adverse reaction categories except non-specific gastrointestinal symptoms. ISMP classified 4,045 of these cases as severe, involving death, disability, or a medical emergency.

The two drugs “where potential hypersensitivity reactions were so frequently reported and severe that this risk should be carefully considered in deciding whether clinical use is appropriate” were Xolair and Invivek.

According to ISMP, 60% of Invivek users developed skin rashes, with 16% of this group having rashes covering 50% or more of their body.

“We identified  131 cases of severe hypersensitivity, including 14 patient deaths and 105 cases of severe cutaneous reactions—more than any other drug studied,” the ISMP report states.

Cutaneous drug reactions occur when the skin reacts to a medication. A red, itchy rash and hives are the most common reactions, and typically occur within 2 weeks of starting a medication. There are many different types of cutaneous drug reactions, including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis, rare and potentially life-threatening conditions.

Drug Reaction Victims Seek Recourse

Both SJS and TEN are almost always linked to reactions to medication. A variety of drugs ranging from over-the-counter to prescription have been implicated in SJS and TEN.

SJS is relatively rare making it difficult for medical researchers to closely study the disease. As such, it is very difficult to predict which person will develop SJS from what drug. Genetics appear to play a role, but several groups of genes are likely involved, making it more complicated than testing for a single allele.

SJS lawsuits have been filed by patients who have suffered SJS, as well as their next of kin. These SJS lawsuits typically allege that either drug makers failed to adequately warn or protect the public from the risk of SJS, or that hospitals failed to recognize and treat the disease correctly. These SJS lawsuits typically seek to recoup the cost of medical care, legal fees, and other costs related to Stevens Johnson Syndrome or Toxic Epidermal Necrolysis.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Stevens Johnson Syndrome attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, SJS lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Help for Victims of Stevens Johnson Syndrome

If you or a loved one were diagnosed with Stevens Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) after taking a prescribed or over-the-counter medication, you may be eligible to take legal action against the drug’s manufacturer. Filing an SJS lawsuit or class action lawsuit may help you obtain compensation for medical bills, pain and suffering, and other damages. Obtain a free and confidential review of your case by filling out the form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.