Wednesday, September 13, 2006

David Graham Speaks

You may at first think this has nothing to do with Clinical Psychology or Psychiatry, but let's keep in mind that this says a lot about the FDA's oversight capabilities.

On PharmaGossip, there is a link and excerpt from David Graham's editorial in the latest JAMA. Graham is one of the few (meaning approximately two) people at FDA who have stepped up to the plate to discuss the risks of certain medications (like the COX-2 inhibitors and antidepressants, especially the COX-2's).

"In a recently reported meta-analysis of 138 randomized trials covering all NSAIDs, Kearney et al27 found that for 37 trials with rofecoxib (85% at 25 mg/d), acute MI risk was increased (RR, 1.73; 95% CI, 1.09-2.82) compared with placebo. With celecoxib (41 trials), the RR was 2.70 (95% CI, 1.30-6.29), which was driven by 21 studies at doses of 400 mg/d or higher. Combined vascular event risk (primarily MI) compared with placebo was also increased for diclofenac (RR, 1.63; 95% CI, 1.12-2.37) and approached statistical significance for ibuprofen (RR, 1.51; 95% CI, 0.96-2.37).27 Risk was not increased with naproxen (RR, 0.92; 95% CI, 0.67-1.26).27

What does this all mean? First, rofecoxib increases the risk of acute MI at low and high doses. This risk begins early in therapy, probably with the first dose. There is no initial 18-month period of immunity from risk.17-19,21, 26 Celecoxib also increases risk at doses higher than 200 mg/d; at lower doses, the potential risk is less clear. Several other NSAIDs increase risk, including the COX-2 selective NSAIDs diclofenac and meloxicam, and the nonselective NSAID indomethacin, and probably ibuprofen. Meta-analyses of randomized clinical trials and observational studies agree that naproxen is neutral for MI risk."

PharmaGossip has a better quote from Graham that I won't steal, so I'd encourage you to check it out.

Link to Graham's editorial here.

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