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Genentech warns doctors of 15 deaths linked to breast cancer drug |
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May 6, 2000
SAN FRANCISCO, MAY 5 (UNB/AP) - Genentech Inc. mailed a letter to doctors warning that the breast cancer drug Herceptin has been linked to 15 deaths and 47 other adverse reactions in patients.
"We sent the letter to oncologists to heighten their awareness and educate them about infrequent adverse events that can occur in certain patients," Genentech spokesman Neil Cohen said Thursday.
The company estimates that 23,000 patients have been treated with Herceptin. The adverse effects included allergic shock and extreme respiratory distress, the letter said.
Although Herceptin is very useful, there are many drugs that could replace it, said Stanford Medical Center oncologist Frank Stockdale.
Reactions this severe to Herceptin had not occurred in clinical trials before the drug gained U.S. Food and Drug Administration approval in 1998, Cohen said.
"A lot of times you might see some safety issues once the drug gets put into a larger patient population," he said.
Cohen said he did not know when the company first heard of the deaths and reactions, but analysis had confirmed the link to Herceptin.
In nine of the 15 deaths, symptoms arose within 24 hours after Herceptin was administered, according to the letter.
Genentech is working with the FDA to have the drug's label amended to reflect the new risks, Cohen said.
Herceptin is used to treat breast cancer patients that have too many copies of the HER2 gene. A healthy version of this gene produces a protein that signals cells to grow and multiply normally. But in women with too much HER2, the breast cells reproduce out of control and spread throughout the body. Herceptin is an antibody that blocks excess HER2, shrinking and eliminating tumors.
Shares of the South San Francisco-based company fell dlrs 4.50, or 3.5 percent, to dlrs 119 after being halted briefly in the afternoon.
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