WARNER-LAMBERT ISOXICAM REVIEW PANEL WILL BE HEADED BY JERRY WEISBACH
Executive Summary
WARNER-LAMBERT ISOXICAM REVIEW PANEL WILL BE HEADED BY JERRY WEISBACH, the president of the firm's pharmaceutical division. Weisbach, according to the firm, will head a panel of twelve "senior scientists" from W.-L's U.S. and overseas operations. The panel was established "to determine the medical facts in light of recent developments" with isoxicam, Warner-Lambert said. Outside experts, according to a company spokesman, will be called in "as appropriate" to aid in the evaluation of the arthritis drug. In an Oct. 28 release, the firm announced it was "temporarily suspending sales of its antiarthritis drug, isoxicam, from all countries in which it is sold, pending further scientific review of isolated skin reactions, primarily in France." The voluntary market withdrawal fllows by two weeks a French govt. action to halt sales in France, after skin reactions were reported in association with isoxicam use. Noting that the skin problems occurred in "small but higher than anticipated" numbers, the company said that in France a hearing on isoxicam safety is pending, and that the drug "is the subject of regulatory action and inquiry in a number of other European countries." The firm maintained in its press release, however, that a review of data will clear the product of safety questions. The market withdrawal, Warner-Lambert said, will facilitate the review of information needed to return the drug to the market. The firm noted that its Maxican NDA, which has been pending for three years, is still active. The release notes "that while scientific evidence to date proved isoxicam to be an effective and well-tolerated therapy when used as directed, it took this action to permit a scientific evaluation of the drug outside the current climate. This will allow sufficient time for the company to show the various European Economic Community members that the data bases they are using are erroneous and incomplete, at least with respect to adverse reaction reports relating to competitive products that isoxicam is being compared to."
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