5/7/2000 – Drugmaker: Breast Cancer Drug Linked to Death

Adverse Reaction
Drugmaker: Breast Cancer Drug Linked to Death

By Jessie Seyfer
The Associated Press

S A N F R A N C I S C O, May 5 — Pharmaceutical maker
Genentech Inc. has warned doctors that the breast cancer drug
Herceptin is linked to 15 deaths and 47 other adverse reactions
in patients.

In a letter to doctors sent Thursday, the company said the
adverse effects included allergic shock and extreme respiratory

“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

An estimated 23,000 patients have been treated with Herceptin.

Severe Reactions
Severe reactions to Herceptin had not occurred in clinical trials
before the drug gained Food and Drug Administration approval
in 1998, Cohen said.

But sometimes reactions can’t be foreseen in trials, he said.

“A lot of times you might see some safety issues once the drug
gets put into a larger patient population,” Cohen said.

Cohen said he didn’t know when the company first heard of the
deaths and reactions, but analysis had confirmed the link to

Symptoms Seen Within 24 Hours
In nine of the 15 deaths, symptoms arose within 24 hours of the
time 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, an antibody, blocks excess HER2, shrinking and
eliminating tumors.

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