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FDA Approves Celebrex for Rare Genetic Disorder


Steinbach says that investigators are focusing on the Cox-2 pathway because, unlike Cox-1, which is present in most human cells, Cox-2 is found only in the presence of inflammation. It is this inflammatory link that makes the drugs effective against arthritis and may also offer a clue to the role of non-steroidal anti-inflammatory drugs (NSAIDs) in prevention of colon cancer, he says.

Steinbach wouldn't speculate further, though, on using Cox-2 inhibitors not just to treat patients with the genetic mutation for FAP, but to prevent the onset of the disease before symptoms present themselves. "This [study] is a first step. It would require further study to assess a Cox-2 inhibitor for prevention," he says.

John Bond, MD, a gastroenterologist and professor of medicine at the University of Minnesota in Minneapolis, told WebMD in an earlier interview, "Most people are predicting that [Cox-2 drugs] probably will play a role in the future to prevent colon cancer altogether. It could be a reason to take the drugs regularly, or it could be a bonus if you take them for something else."

Research gives indications that the Cox-2 inhibitors may even help prevent a range of cancers beyond the colorectal varieties. Andrew Dannenberg, MD, professor of medicine at Weill Medical College at Cornell University in Ithaca, N.Y., told WebMD, "In the laboratory, we've demonstrated that Cox-2 is overexpressed in a variety of human malignancies, ranging from lung cancer to pancreatic cancer to head and neck cancer to breast cancer."

"There are now people looking at skin cancer and prostate cancer and things like that ... in preclinical models," says Ray DuBois, MD, director of cancer prevention at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn. "The bottom line in all the studies that I've seen is: When you inhibit the Cox-2, you block the growth of the tumor. And that's a very reproducible, well-supported finding."

In the meantime, the FDA stresses that celecoxib is only to be given to patients with FAP in addition to their current treatment, which usually involves colectomy by early adulthood.

The main side effects seen in the trial patients were diarrhea and indigestion. Since gaining FDA approval, Celebrex has been very well received, mainly because, unlike traditional NSAIDs, it does not cause gastric ulcerations.



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