The Food and Drug Administration (FDA) in partnership with OSI Pharmaceuticals Inc., and Genentech have issued a warning letter to healthcare professionals informing them of new safety information added to the WARNINGS AND PRECAUTIONS section of the cancer treatment drug Tarceva.
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.