Is Bextra any better than Vioxx?

Pfizer and the FDA’s planned studies should shed more light on the safety of these drugs.

Many students do not consider the risks when they pop painkillers to kick headaches, pain from sore muscles or menstrual cramps. Most commonly, these students take nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen and acetaminophen.

But a relatively new, more selective class of nonsteroidal anti-inflammatory drugs that cause fewer gastrointestinal problems than the traditional drugs has become very popular in recent years, especially among athletes.

These new drugs, called cox-2 inhibitors, include Merck & Co.’s Vioxx and Pfizer’s Celebrex and Bextra. Vioxx was pulled from the market in September after studies confirmed it increased patients’ risk of cardiovascular disease, and similar concerns are arising over its competitors, especially Bextra.

Bextra’s label already warns against serious skin reactions as a possible side effect, and some trials found an increased risk of unspecified “cardiovascular events” in Bextra patients who had cardiac bypass surgery.

Bextra is labeled for pain relief from arthritis and menstrual cramps. Pfizer’s clinical trial apparently showed no increased risk of cardiovascular problems in arthritis patients taking the drug, but the compnay plans to study its long-term effects on cardiovascular health. The Food and Drug Administration also plans to launch similar studies on all cox-2 inhibitors to determine if they all have similar effects on cardiovascular health.

That Vioxx is no longer available troubles some student-athletes who say it was much more effective than Bextra. But its risks were too great to justify its continued use. Currently, there is not enough information to make the same decision about Bextra – Pfizer and the FDA’s planned studies should shed much more light on the safety of these drugs.

In the meantime, student-athletes and other Bextra users would do well to proceed cautiously. While initial studies do not suggest Bextra is as dangerous as Vioxx, problems might surface to change that perception. Certainly, patients with skin reactions or pre-existing cardiovascular disease should avoid these drugs, and others should have conversations with their physicians before blindly beginning treatment with Bextra.

It is laudable that Pfizer wants to prove the safety of its product, and the FDA’s more comprehensive study will hopefully determine if a class effect exists. Until then, however, users and physicians must educate themselves about the drug’s risks.