The Food and Drug
Administration has approved an arthritis drug to help treat a rare genetic intestinal
disorder. Celebrex, a Cox-2 selective nonsteroidal
anti-inflammatory drug commonly used to treat arthritis, can reduce the number
of colorectal polyps associated with familial adenomatous polyposis. Patients
with FAP develop large numbers of polyps, which increase their risk of
developing colon cancer or rectal cancer (see Colorectal Cancer) at a young
age. The FDA says Celebrex should be used
only in conjunction with standard care for FAP, which usually includes surgery
to remove all or part of the lower intestine in young adults and continued
monitoring of the remaining intestinal tissue.
The FDA accelerated approval for
Celebrex based on a six-month, placebo-controlled trial in 83 patients that
showed a 28 percent reduction in the number of polyps in Celebrex patients
compared with a 5 percent reduction in placebo patients. The most common side
effects were diarrhea and indigestion.
Because the study did not show the
clinical benefit of reduced colorectal polyps, or whether the effect of Celebrex
will last after use is discontinued, the FDA is requiring the manufacturer to
conduct further testing.