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Merck Vioxx Meningitis Case Reports Published By FDA Drug Safety Office

Executive Summary

FDA's publication of five case reports of aseptic meningitis associated with Vioxx use will help the agency assess whether an increased risk of the disease is associated with the COX-2 inhibitor

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COX-2 Inhibitors Overused As Short-Term Therapy, Express Scripts Says

COX-2 inhibitors are over-prescribed for short-term pain and therefore do not achieve the gastrointestinal safety benefit needed to be considered cost-effective, Express Scripts' drug utilization studies conclude

COX-2 Inhibitors Overused As Short-Term Therapy, Express Scripts Says

COX-2 inhibitors are over-prescribed for short-term pain and therefore do not achieve the gastrointestinal safety benefit needed to be considered cost-effective, Express Scripts' drug utilization studies conclude

From The Quarterly Conference Calls....

Advair for COPD: GSK hopes to receive approval of Advair (fluticasone/salmeterol) for chronic obstructive pulmonary disease in "a few months," CEO J.P. Garnier tells April 24 conference call. Although an FDA advisory committee "was unabashedly in favor" of the new indication, the agency "asked us for some data and we have now supplied the data.... I don't expect this to come to a fast resolution." FDA approved only the NDA for salmeterol (Serevent) for the COPD claim (1"The Pink Sheet" April 1, p. 27)....Off-label use likely: While the Advair COPD indication has hit a snag at FDA, "there is use in the medical community," Garnier notes. "This is not encouraged. It just happens with specialists who have experience with Advair in COPD. We're getting good reports. We're trying to manage this as best we can"...

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