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SYNTEX KETOROLAC RELABELING IN EUROPEAN COUNTRIES "LIKELY"

Executive Summary

SYNTEX KETOROLAC RELABELING IN EUROPEAN COUNTRIES "LIKELY" following suspension of sales of the non-steroidal anti- inflammatory drug in Germany, Syntex said June 11. One country, the U.K., already has proposed labeling changes relating to dosing and duration, Syntex said. The company expects to make the proposed changes by the end of June. Ketorolac is marketed in the U.S. under the trade name Toradol. "A number of regulatory agencies of European countries have met and are meeting to evaluate the risk/benefit profile of ketorolac," Syntex said. German regulatory authorities have informed Syntex that they intend to revoke the licenses of both oral and injectable ketorolac (marketed as Toratex). The decision "is based on the German regulatory authorities' analysis of data concerning the product's risk/benefit ratio," Syntex said. The firm noted that regulatory agencies throughout Europe and in the U.S. have access to the same data provided to Germany. "No country in which ketorolac is currently marketed has advised Syntex that it plans to take action similar to Germany." "Syntex disagrees with this action," the company said. Syntex has three weeks to respond to the German regulatory agency. The firm "has voluntarily suspended sales of ketorolac...pending receipt and evaluation of Syntex' response by the German regulatory authorities." Toratex oral is marketed for acute treatment of moderate to severe pain and Toratex intramuscular is indicated for acute treatment of postoperative pain. The product was launched in Germany in January 1992. Syntex maintains that "the results of ongoing regulatory discussions on ketorolac in Europe will not have a material adverse effect on the current sales level of the product in the U.S." Domestic sales of Toradol were $192.2 mil. through the nine months ended April 30, while worldwide sales were $241 mil. ("The Pink Sheet" June 7, p. 17). Sales in Germany for the period were $3 mil.; sales in the rest of Europe were $28 mil., Syntex said. The company noted that, in its overall ketorolac database, "most of the serious adverse events reported have occurred in patients receiving injectable ketorolac for treatment of postoperative pain. Such patients are at high risk of adverse events related to their underlying medical and surgical conditions." Syntex did not disclose the particular adverse events cited by Germany or the U.K. in making their decisions. "In an ongoing, large study designed to monitor the safety of ketorolac use," Syntex said, "it is reassuring to observe that, so far, the study indicates that overall mortality rates are lower in the ketorolac-treated patients than in those receiving narcotics. Syntex believes that when ketorolac is used according to label instructions, it provides an important clinical benefit to physicians and patients."
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