Thursday, September 14, 2006

Vioxx in JAMA: More Bad News

From the JAMA edition set to go October 4th:

CONCLUSIONS: In this comprehensive analysis of 114 randomized trials with 116,094 participants, rofecoxib (Vioxx) was associated with increased renal and arrhythmia risks. A COX-2 inhibitor class effect was not evident. Future safety monitoring is warranted and may benefit from an active and continuous cumulative surveillance system.

More could have been done to ferret out Vioxx's harmful side effects before any real damage was done. Also, heart-attack risk rose as the dose of Vioxx increased. This risk was most pronounced in the first month after users started taking the drug.

There's a lot of blame to go around -- starting with Merck, according to Dr. Graham. He also cast some blame on the FDA. "In this case, they knew before the drug came on the market that Vioxx increased the risk of heart attack,." Link.

I will slog through it, but you can read it here.