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Alert Number 63

Vioxx Gone - Now Celebrex Is Out Too

Date: December 17, 2004

It was only a matter of time, as we waited for the second shoe to drop.

I had a sinking feeling that after the withdrawal of Vioxx from the market in the fall of this year (see prior Alerts, #45 and #48, dated October 1 and October 9, 2004 respectively), after it was shown to cause increased risk of heart disease, it was only a matter of time before the other big name Cox-2 inhibitor, Celebrex, would face similar problems.

The second shoe dropped today. According to the FDA, people taking 400 to 800 milligrams per day of Celebrex are roughly two and half times as likely to have heart attacks, compared to people getting a placebo. This was even higher than the risk shown with Vioxx. So much so that the National Cancer Institute has suspended a clinical trial using Celebrex as a cancer prevention agent, as of December 2004.

If you held Pfizer stock and you were taking Celebrex as a way of controlling your CLL, you were hurt in two ways today, as Pfizer stock price plunged on the news. I would not rush out either to get a prescription for Bextra, the third Cox-2 inhibitor on the market, not right away. It is entirely possible that this drug too would face similar problems. The problem seems to be linked to Cox-2 inhibition, a pathway shared by all three drugs.

Aspirin anyone, for that headache?

Be well,


Mayo Clinic Q & A

Link to document on Mayo Clinic website
(Editor's note: Unfortunately by mid-2007 Mayo seems to have reorganized this page right out of its website, so of course, the link does not work any more.)

Celebrex shows heart attack risk

Q: I was taking Vioxx for my arthritis, and then it was pulled from the market. So I switched to Celebrex. Now, I understand that Celebrex also may cause heart problems? - No Name/Minnesota

A: The arthritis drug celecoxib (Celebrex) is a COX-2 inhibitor in the same family as rofecoxib (Vioxx) and valdecoxib (Bextra). In September 2004, Vioxx was voluntarily withdrawn from the market because of an increased risk of heart attack and stroke among people taking the drug. Recent data suggests that the use of Celebrex also is associated with increased risk of heart attack and stroke. In December 2004, the National Cancer Institute suspended the use of Celebrex in a cancer prevention trial after finding that participants taking 400 milligrams (mg) to 800 mg of the drug daily had a 2.5 times greater risk of heart problems than those taking a placebo had. A separate cancer prevention study found no increased heart risk in people taking 400 mg of Celebrex a day.

Although the risk that an individual would have a heart attack or stroke related to Celebrex is very small, it may be appropriate to contact your doctor to discuss possible alternative medications.

By Mayo Clinic staff

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