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In Brief: McNeil Ultram

Executive Summary

McNeil Ultram: FDA Drug Abuse Advisory Committee meeting scheduled for Feb. 19 has been postponed until April, so that the committee has sufficient time to review a large amount of data from multiple sources, the agency said. The committee will discuss a scheduling action for tramadol and evaluate the effectiveness of the independent steering committee in detecting and preventing Ultram abuse. Ultram has been available since March 1995. In March 1996, the company sent a "Dear Doctor" letter noting 115 cases of drug abuse, withrawal or overdose and 83 cases of seizures during the first year of use...
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