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Pharmacia Corp. has warned physicians using Camptosar (irinotecan),
a standard therapy for colorectal cancer, about diarrhea and other
possible side effects, according to the U.S. Food and Drug Administration.
The FDA posted
on its Web site a letter that Pharmacia sent to doctors on May
10th telling them to monitor patients for diarrhea, fever, or
excess reduction of some white blood cells.
"The
prescribing information has been revised to identify patients
at higher risk of severe toxicity, to clarify dose modification
guidelines, and to augment the information about management of
treatment-related toxicities," Pharmacia said in its letter.
The principal
changes were:
- "Patients
with diarrhea should be carefully monitored and given fluid
and electrolyte replacement if they become dehydrated, or antibiotic
therapy if they develop ileus, fever, or severe neutropenia..."
- In patients
receiving irinotecan in combination with other chemotherapy
drugs in clinical trials, higher rates of hospitalization, neutropenic
fever, thromboembolism, first-cycle treatment discontinuation,
and early deaths were observed in some patients.
- "After
the first treatment, subsequent weekly chemotherapy treatments
should be delayed in patients with active diarrhea until return
of pretreatment bowel function for at least 24 hours without
need for antidiarrhea medication."
Other
sources: FDA, Pharmacia
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