Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) along with OSI Pharmaceuticals, Inc. and Genetech has announced that new safety information has been added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for the cancer drug erlotinib, known by the brand name Tarceva. The new labeling warns health care professionals of the risk of sometimes fatal conditions of gastrointestinal perforations, and bullous, blister and exfoliative skin conditions including cases suggestive of Stevens Johnson Syndrome (SJS) and its most serious form, toxic epidermal necrolysis (TEN), during the use of Tarceva.

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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.

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