WASHINGTON — The Food and Drug Administration and Genentech
have warned doctors that Avastin, used to treat colorectal cancer, increases
patients’ risk of suffering heart ailments — including chest pain, strokes,
mini-strokes and heart attacks.
Avastin also raised the risk of
patients dying from those heart ailments.
Colleen Sweeney, Genentech
spokeswoman, said Friday that some patients taking Avastin died from those
heart ailments but could not say how many. “I don’t have the data,” Sweeney
said.
During clinical trials before the
drug’s approval, one patient died but a “clear relationship” could not be
determined between Avastin use and the heart-related fatality, she said.
Additional analyses led to the issuance of the drug warning.
“Right now, we’re working with the
FDA, with these analyses, to update the Avastin label,” she said.
Genentech would not say how many
patients were prescribed Avastin after FDA approval. “We don’t give out
prescription information,” Sweeney said.
Warning
letter to doctors
But the company did tell health care providers in its warning letter that patients whose cancer has spread to the rest of their bodies were twice as likely to suffer serious heart ailments if they received Avastin with their chemotherapy. The highest-risk individuals had a past history of such heart problems and were older than 65.
The FDA on Feb. 26 approved the
product — a genetically engineered version of a mouse antibody containing mouse
and human components — after testing showed patients receiving the drug
intravenously lived an additional five months. The drug, the first approved
angiogenesis inhibitor to treat colorectal cancer, works by blocking new blood
vessels, essentially depriving cancer cells of the oxygen and nutrients they
need to thrive.
According to the Centers for
Disease Control, cancer of the colon or rectum is the nation’s third most
common cancer and is the second leading cause of cancer-related deaths.
...
No comments:
Post a Comment
Note: only a member of this blog may post a comment.