Public Citizen Meridia petition denied

Executive Summary

Abbott's Meridia (sibutramine) will remain on the market after FDA denies Public Citizen's 2002 petition to withdraw the weight-loss drug. In its Aug. 9 FDL-1response, FDA acknowledges some risks associated with Meridia but says they can be addressed by Abbott's recently revised risk management program. The agency also disputes Public Citizen's use of AERS reports to support its argument that the fatality rate associated with Meridia is enough to warrant its withdrawal. Abbott's 9,000-patient long-term safety study (SCOUT) may address the issue; as of April, 8,000 patients had been enrolled (1"The Pink Sheet" June 25, 2001, p. 13)...