Rofecoxib (Vioxx - Merck) has been withdrawn from the market due to an increased risk of cardiovascular complications associated with its long-term use. The question remains whether all selective COX-2 inhibitors carry the same risk. Full-page advertisements in newspapers for celecoxib (Celebrex - Pfizer), the most widely used COX-2 inhibitor, assure the public that it does not.

Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) may be asking their health care providers if they should continue, and some may be asking for alternatives. For most patients taking nonspecific NSAIDs, it would be reasonable to continue. For those who are taking the COX-2 selective celecoxib (Celebrex) because they cannot tolerate the gastrointestinal (GI) effects of nonspecific NSAIDs, it seems reasonable to continue at doses no higher than 100 mg b.i.d. or 200 mg once daily; at these dosages cardiovascular risk has been no higher than with placebo. All NSAIDs, including COX-2...

The results of a clinical trial (PRECISION) comparing the cardiovascular safety of the COX-2 selective NSAID celecoxib (Celebrex, and generics) with that of ibuprofen and naproxen, which are nonselective, have been described in the lay press in terms that may overestimate the safety of celecoxib.

Celecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis and rheumatoid arthritis.

The FDA has authorized two manufacturers (Teva, Mylan) to market generic formulations of celecoxib (Celebrex – Pfizer), the only COX-2 selective inhibitor remaining on the US market. Celecoxib is less likely than nonselective NSAIDs to cause gastric ulcers or other GI toxicity,1 and unlike traditional NSAIDs, it does not have an antiplatelet effect.Celecoxib is much less COX-2 selective than rofecoxib (Vioxx), which was removed from the US market because of an increased risk of cardiovascular events. One analysis of randomized clinical trials that included a total of about 26,000 patients...

Consensi (Coeptis/Burke), a fixed-dose combination of the calcium channel blocker amlodipine (Norvasc, and others) and the COX-2 selective NSAID celecoxib (Celebrex, and generics), has been approved by the FDA for treatment of patients who have hypertension and osteoarthritis.

At a US Senate hearing prompted by the withdrawal of Vioxx, an FDA officer cited 5 drugs as potentially dangerous. It may be useful to revisit Medical Letter reviews of these drugs.

Valdecoxib (Bextra - Pharmacia/Pfizer), a selective cyclooxygenase (COX-2) inhibitor similar to celecoxib (Celebrex) and rofecoxib (Vioxx), was recently approved by the FDA for treatment of osteoarthritis, rheumatoid arthritis and primary dysmenorrhea.

Selective COX-2 Inhibitors and Bleeding Risk: An Additional Note - The Medical Letter article on Drugs for Pain (August 21, 2000) stated that the selective COX-2 inhibitors celecoxib (Celebrex) and rofecoxib (Vioxx) do not inhibit platelet aggregation or bleeding time. Perhaps we should have added, as we did in discussing use of these drugs in rheumatoid arthritis (July 10, 2000), that both celecoxib and rofecoxib, if given with warfarin (Coumadin, and others), increase INR and prothrombin time values and may increase the risk of bleeding.

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) with some cyclooxygenase-2 (COX-2) selectivity in vitro, has been approved by the FDA for treatment of osteoarthritis.