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

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.

STEVENS-JOHNSON SYNDROME LAWYER

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.