New warnings added to prescribing information for cancer drug

ROCKVILLE, Md. The Food and Drug Administration last week posted a notification to healthcare professionals around the safety profile of the cancer drug Tarceva to its MedWatch Web site.

Adverse events associated with the drug include gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.

The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports, the FDA stated.