Tarceva Side Effects Could Include Stevens-Johnson Syndrome: FDA

The FDA announced Friday that new warnings will be added to the cancer medication Tarceva, indicating that possible side effects could include an increased risk gastrointestinal problems, eye disorders and skin conditions consistent with Stevens Johnson syndrome and toxic epidermal necrolysis.

Tarceva (erlotinib), which was first introduced in 2004 by Genetech Inc. and OSI Pharmaceuticals, is approved by the FDA to treat lung cancer and pancreatic cancer.

The medication is part of a class of drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, which block production of the EGFR protein that is believed to be a factor in the growth of cancer cells.

According to an FDA MedWatch alert issued on May 8, 2009, new safety information will be added to the warnings and precautions section of the drug’s label about reports of users who developed gastrointestinal perforation, ocular disorders, bullous, blistering and skin conditions that were suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, including some fatalities.

Gastrointestinal perforation involves the development of holes in the wall of the stomach, small intestine or large bowel. It allows the intestinal contents to flow into the abdominal cavity, potentially resulting in peritonitis, emergency surgery or death.

Individuals who are taking Tarceva together with an anti-angiogenic agent, corticosteroid, NSAID or taxane-based chemotherapy and those who have a history of peptic ulcers or diverticular disease could face an increased risk of the Tarceva gastrointestinal side effects.

The eye problems associated with Tarceva have included corneal perforation, corneal ulceration, abnormal eyelash growth, keratoconunctivitis sicca or keratitis, which could threaten or impair sight. Doctors have warned to stop or interrupt use of Tarceva if patients problems such as eye pain.

Tarceva use has also been associated with serious and potentially life threatening skin conditions, such as bullous, blistering and possibly Stevens-Johnson syndrome, which causes the skin to burn from the inside out. Severe cases of Stevens-Johnson syndrome are referred to as toxic epidermal necrolysis, which involves situations where more than 30% of the body is covered by skin lesions.

According to the FDA, fatalities have been associated with the possible Tarceva Stevens-Johnson syndrome side effects and gastrointestinal perforations.

This alert is the second time in the past year that the manufacturers have updated the Tarceva warning label about potentially life-threatening problems. In September 2008, a was sent letter to healthcare professionals warning about other potential Tarceva side effects, including a risk of liver failure, hepatorenal syndrome and death.