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Executive Summary

SYNTEX TORADOL LABELING CHANGES UNDER DISCUSSION WITH FDA as the agency examines postmarketing data for the non-narcotic analgesic ketorolac. FDA and the company are negotiating labeling changes in light of adverse reaction reports and interim results of Syntex' European postmarketing safety study, FDA said. Worldwide, 97 deaths have been associated with Toradol use out of 26 mil. patients as of March 31, Syntex said. In June, German regulatory authorities informed Syntex that they intended to revoke the licenses for both oral and injectable ketorolac (marketed as Toratex). Syntex has appealed that decision ("The Pink Sheet" June 14, T&G-8). The CPMP has recommended changing the dose, duration of use and the indications sections of labeling pending completion of the post-marketing trial in December. FDA has not proposed any changes to the dosing, duration of use or indications sections, Syntex said. The labeling changes may be accompanied by a "Dear Doctor" letter, FDA said. The adverse reaction reports apparently are associated with use of intramuscular Toradol. At the time of the German action, Syntex pointed out that most serious adverse events reported to the company "have occurred in patients receiving injectable ketorolac for treatment of post-operative pain." The U.S. label covers both oral and injectable ketorolac. In the U.S., ketorolac labeling states that Toradol IM "is not recommended for use beyond five days at recommended doses because of the increase in side effects which may occur." Labeling carries warning statements against possible gastrointestinal events such as ulceration, renal events including renal failure, hemorrhage and hypersensitivity reactions.

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