Genentech issues Herceptin warning

DNA issued a Dear Doctor letter notifying health care providers of 62 postmarketing reports of serious adverse events with the company's Herceptin trastuzumab anti- HER2 monoclonal antibody to treat breast cancer. Adverse events included hypersensitivity, infusion and pulmonary reactions, some of which were fatal. A total of 15 patients have experienced fatal pulmonary and other adverse events following Herceptin treatment, and 9 of those patients died after having onset of symptoms within 24 hours of Herceptin infusion.

In most patients, symptoms occurred with the first dose of Herceptin, and most patients with fatal outcomes had pre-existing pulmonary compromise due to lung disease or cancer. DNA noted that 25,000 patients have been treated with Herceptin since the product was approved for marketing in 1998. ...