Genentech Inc. announced on Thursday that it was sending "Dear Doctor" letters to physicians concerning its breast cancer drug Herceptin.
Herceptin has been linked to 15 deaths. FDA Officials still believe that Herceptin is a very safe drug despite the reports of fatal reactions to treatment.
"I think it's still a very safe drug as cancer drugs go, but we don't want the public to believe that it's impossible to experience serious complications" Dr. Patricia Keegan, a deputy director in the FDA's Center for Biologics Evaluation and Research, said in an interview.
Herceptin is generally well tolerated. The most common adverse events with
Herceptin administration include fever and chills, which are seen in 40 percent of
patients. There is an increased risk of cardiac dysfunction with Herceptin use,
although severe outcomes are infrequent.
Despite the belief that the drug is safe, the FDA is in agreement with the company's decision to send the Dear Doctor letters.
For more information regarding Herceptin, visit the Herceptin Web Site, where you'll find prescribing information,
clinical materials and patient education materials. The site does not currently post information regarding the fatalities associated with Herceptin therapy.