Stevens-Johnson Syndrome Skin Reactions Linked to Several Drugs: FDA Reports

Austin Kirk

By Austin Kirk
Posted June 5, 2009


The FDA released their quarterly list of drugs that are being investigating for potential health risks, and a number of the drugs listed had potential signals for Stevens-Johnson Syndrome side effects or other severe skin reactions.

In 2007, Congress enacted legislation that requires the FDA to release a list of drugs identified through the Adverse Event Reporting System (AERS), which show potential signs of serious health risks. The FDA releases the list about every three months, and the most recent list released on June 4, 2009, identified 19 different drugs or class of medications.

For the period between October 2008 and December 2008, potential skin problems or Stevens-Johnson Syndrome were identified in association with the use of Chantix, Detrol, Provigil, Nuvigil and hydrochlorothiazide in combination products.

Stevens-Johnson Syndrome, commonly referred to as SJS, is a potentially life-threatening skin condition where the skin burns from the inside out. It is almost always associated with adverse drug reactions, and can lead to severe scarring, disfigurement, blindness, organ failure, breathing disorders and death.

When the skin lesions associated with SJS cover more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis, or TEN.

Chantix (varenicline) is a well-known stop-smoking drug manufactured by Pfizer, which is indicated on the list as showing potential signals for “serious skin reactions” as well as several other potential problems. Chantix Stevens-Johnson syndrome reports were first identified early last year in an independent report by the Institute for Safe Medication Practices.

Detrol (tolterodine) is another Pfizer medication, which is prescribed to treat overactive bladders and incontinence. The FDA specifically indicated that the drug has been linked to cases of Stevens-Johnson syndrome and that they are continuing to evaluate the issue to determine the need for any regulatory action.

Provigil (modafinil) was originally identified as having possible connections to SJS and TEN in 2007, after the FDA received six cases of severe skin reactions that included SJS, TRN, and other conditions. Nuvigil (armodafanil) was not mentioned with it at the time, but the FDA put the two drugs together on the potential risks list due to their similarities.

Provigil and Nuvigil already include warnings about potentially severe skin reactions, but FDA says that it is investigating whether more action needs to be taken. Provigil and Nuvigil are used to treat excessive sleepiness due to narcolepsy, sleep apnea or shift work sleep disorder.

The list also notes that the FDA is investigating Hydrochlorothiazide, a diuretic, in combination with other drugs, as a potential cause of skin reactions, but did not specifically identify Stevens-Johnson Syndrome as a concern. The FDA indicates that they are evaluating whether the current labeling is adequate for the various combination products that contain hydrochlorothiazide.

Inclusion of a drug on the list does not mean that it has serious health risks, just that the FDA is investigating possible risks. The FDA will release individual warnings, notices, or labeling requirements once investigations of the potential risks are completed.


The dangerous drug lawyers at Saiontz & Kirk, P.A. investigate potential Stevens-Johnson Syndrome lawsuits throughout the United States. Free consultations are provided to help determine if compensation may be available as a result of a manufacturer’s failure to warn about this serious and potentially life-threatening side effect.

If you, a friend or family member have suffered from Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) after taking a prescription medication, request a free claim evaluation.

6 Comments • Add Your Comments

  • Edward says:

    i had the symbols of this disease and my neice had the same thing and she let me use her medicine.

    Posted on June 11, 2009 at 12:29 pm

  • Lynda says:

    I was hospitalized in Mexico with SJS and spent 4 days in ICU as well as additional time in a private room before being discharged. Was very weak and taking prescription medications for several weeks after this and am still not over the effects of the SJS. Have all the Hospital and Physicians reports as well as all the costs of my hospitalization.

    Posted on May 1, 2012 at 2:48 pm

  • Jacob says:

    Anne,Thank you! Until experiencing this we had no idea what SJS even was let alone the hell it can cause to one’s body soul. Life chnaigng indeed! This is has been such a rough road and I am so grateful for people like you who are out there and who get it. Thank you!

    Posted on June 30, 2012 at 9:36 pm

  • Verna says:

    My sister died 3 days ago. She was diagnosed with SjS in Nov. the family was not told she had this until we were told she would be dead within 24-72 hrs. If someone would have explained about the drug that could induce SJS, she would have not let them give it to her.But because she was diagnosed a year after her first attack,they said it was to late for aggressive treatment.We were also told that because she signed a paper POLST several years ago thateven had they known she had SJS early on they would have not treated it aggressivly due to the fact she didn’t want to hooked to life support. Life support and aggressive treatment to spare her the torture her body went through I do not believe is what my sister meant when she thought of life support. I am angery about how she needlessly suffered.

    Posted on December 15, 2012 at 10:57 pm

  • Samanthia says:


    Posted on August 4, 2014 at 4:31 pm

  • Marie says:

    My husband suffered a severe reaction from hydroclothiazide in 2009 and since then has been on prednisone to control the flare up.John Hopkins chief dermatologist was the first to diagnose this drug reaction.When admitted to Washington Hospital Center he was told he had Stevens Johnson Syndrome. Now his entire body has a reaction to sunlight therefore his entire life has been altered because of this medication.No activities outside,no family reunions,picnic absolutely no daytime at all. When he goes to the doctors his entire body,face,hands everything has to be covered. He has not drove a car for over 2 years now.His face has been scarred from his skin burning so bad and if he goes off the prednisone whether he is inside or out his entire body swell and blister .I feel at loss because now his doctors want to say he has Photo Dermatitis however when he goes to the hospital they record pass history as Steven Johnson Syndrome and allergies is Hydroclorthiazide.

    Posted on October 21, 2014 at 8:48 pm

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