Sept 99

The Food and Drug Administration recently approved two new drugs in the new class of anti-inflammatory agents called COX-2 inhibitors. The drugs, Celebrex (celecoxib) and Vioxx (rofecoxib) are anti-inflammatory drugs that work like many of the existing drugs, called NSAIDs, which stands for non-steroidal anti-inflammatory drugs. However, there is one very significant difference with Celebrex and Vioxx: the incidence of gastrointestinal ulcerations is not far from that of placebo, about 2-3%, as opposed to other NSAIDs in which ulceration occurs at about a 16% rate. This is tremendous news for those at risk for gastrointestinal ulceration/bleeding from the use of NSAIDs yet need relief from pain and inflammation associated with osteo- or rheumatoid arthritis where using more traditional NSAIDs was contraindicated.

Although the FDA has placed a warning that Celebrex and Vioxx are still associated with ulcers, the clinical data thus far show a rate that is far lower than other NSAIDs. For example, in one study, in comparison to placebo and Naprosyn 500mg twice daily, the following percent incidence of ulcerations occurred: Placebo- 2.3 and 2%; Celebrex- 3.4 and 3.1%; and Naprosyn- 16.2 and 17.6%. As you can see, there is a very low incidence of ulcerations in both the placebo group and the Celebrex group. There is other data available with similar findings.

Celebrex can be used in osteoarthritis for pain relief at doses of 100mg twice daily or 200mg once daily with no further benefit of doses over 200mg daily. Celebrex can be taken without regard to meals. Common side effects are stomach upset, nausea, diarrhea, flatulence. Celebrex is effective in managing pain and inflammation in those with rheumatoid arthritis. The effective daily dose may need to be higher than in those with osteoarthritis, up to 400mg daily as divided doses. E.g. 200mg twice daily.

For the treatment of osteoarthritis, 12.5-25 mg of Vioxx taken once daily is recommended. Side effects may include: dizziness, heartburn, tinnitus, among others. No anaphylactic reactions have been reported.

   Inhouse Pharmacy