The safety information comes from routine pharmacovigilance activities of clinical study and post marketing reports.

Tarceva monotherapy is indicated for the treatment of patients who have locally advanced or metastic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, erlotinib also is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastic pancreatic cancer.

SJS/TEN is a severe adverse reaction that has been linked to more than 200 medications. It is most commonly associated with ibuprofen, antibiotics and anti-seizure medication. SJS/TEN is rare but life-threatening, causing a rash to form on the skin. The rash blisters over and the skin peels off in sheets. In some, as much as 90 percent of the skin can peel away, leaving the victim susceptible to infection. Patients are often treated in burn units and put into a drug-induced coma to help ward off infection. Blisters also can form on the mucus membranes, such as the eyes, mouth and internal organs, causing dehydrations and ocular problems.

Source: FDA

SOURCE: Stevens Johnson Syndrome › Cancer drug linked to serious skin condition SJS/TEN

The new information, gathered from a clinical study and postmarketing reports, revealed sometimes fatal incidences of gastrointestinal perforation, bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens Johnson Syndrome (SJS) and/or toxic epidermal necrolysis (TEN) and ocular disorders including corneal perforation or ulceration.

SJS/TEN is a rare but life-threatening reaction to medication that presents with a rash that blisters over, causing the skin to peel off in sheets. It can also affect the mucus membranes, causing blistering and ulceration of the mouth, eyes and internal organs. Several commonly used medications have been linked to SJS/TEN including ibuprofen, antibiotics and antiviral drugs.

Tarceva is used in the treatment of locally advanced or metastic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. It is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

The updated WARNINGS AND PRECAUTIONS section of the labeling reflects dose interruption and/or discontinuation instructions. For any questions, or to report adverse events suspected to be associated with the use of Tarceva, call 1-877-TARCEVA (1-877-827-2382).

Alternatively, adverse event information may be reported to the FDA’s MedWatch reporting system by phone at 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857, or by the internet at http://www.fda.gov/medwatch/index.html.

SOURCE: Stevens Johnson Syndrome › New SJS warnings added to cancer treatment drug