New breast cancer drug linked to 15 deaths.
May 14, 2000 -- A promising new drug has been linked to dozens of serious side effects and 15 deaths in women who received it as part of their treatment for aggressive breast cancer. But both the drug's manufacturer and the FDA say the side effects are rare and only occurred in a small percentage of women receiving it.
The drug, Herceptin, is designed to attack specific cancer cells that produce a protein that makes tumors grow faster. Approximately 30% of women with metastatic breast cancer have tumors that produce the protein.
In September 1998, Herceptin was approved by the FDA. But on May 3, the drug's manufacturer sent a letter to doctors around the country, advising them of the possibility of potentially fatal allergic reactions and breathing problems. To date, 62 serious side effects have been reported, and 15 women died soon after receiving the drug.
In almost all of the cases, the women became seriously ill after their first dose of the drug, either during the treatment or within the first 12 hours after it, although some reports of illness were noted 24 hours or more after treatment. Like other forms of cancer therapy, Herceptin is given as an infusion once a week. It may be given alone or in combination with other cancer drugs, like Taxol.
Genentech, the drug's manufacturer, says most of the 62 patients who developed serious side effects after receiving Herceptin had lung disease and/or their breast cancer had spread to their lungs.
"For the majority of patients, I think it's still a very, very safe drug," Mary Cianfrocca, MD, a cancer specialist at Fox Chase Cancer Center in Philadelphia, tells WebMD. In light of the new warning, she says doctors will have to explain the additional risks to patients with breast cancer who are considering Herceptin therapy.
"You have to discuss with those patients that there is a small risk of having a very severe reaction, but that it appears to be limited to those with severe [lung] disease," Cianfrocca tells WebMD. And people should keep in mind that Herceptin is a drug for patients with aggressive cancers who have few other options.
Breast Cancer Drug Linked to 15 Deaths
May 14, 2000 -- A promising new drug has been linked to dozens of serious side effects and 15 deaths in women who received it as part of their treatment for aggressive breast cancer. But both the drug's manufacturer and the FDA say the side effects are rare and only occurred in a small percentage of women receiving it.
The drug, Herceptin, is designed to attack specific cancer cells that produce a protein that makes tumors grow faster. Approximately 30% of women with metastatic breast cancer have tumors that produce the protein.
In September 1998, Herceptin was approved by the FDA. But on May 3, the drug's manufacturer sent a letter to doctors around the country, advising them of the possibility of potentially fatal allergic reactions and breathing problems. To date, 62 serious side effects have been reported, and 15 women died soon after receiving the drug.
In almost all of the cases, the women became seriously ill after their first dose of the drug, either during the treatment or within the first 12 hours after it, although some reports of illness were noted 24 hours or more after treatment. Like other forms of cancer therapy, Herceptin is given as an infusion once a week. It may be given alone or in combination with other cancer drugs, like Taxol.
Genentech, the drug's manufacturer, says most of the 62 patients who developed serious side effects after receiving Herceptin had lung disease and/or their breast cancer had spread to their lungs.
"For the majority of patients, I think it's still a very, very safe drug," Mary Cianfrocca, MD, a cancer specialist at Fox Chase Cancer Center in Philadelphia, tells WebMD. In light of the new warning, she says doctors will have to explain the additional risks to patients with breast cancer who are considering Herceptin therapy.
"You have to discuss with those patients that there is a small risk of having a very severe reaction, but that it appears to be limited to those with severe [lung] disease," Cianfrocca tells WebMD. And people should keep in mind that Herceptin is a drug for patients with aggressive cancers who have few other options.
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