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Executive Summary

LILLY METHOHEXITAL LOW REPORTING INCIDENCE ON DAWN (Drug Abuse Warning Network) indicates that the anesthetic does not have a high abuse potential and should not be placed in Schedule IV under internatl. control. In recent comments to FDA, Lilly said that "reports to the company and the DAWN compilation do not indicate any significant level of abuse of methohexital." The company said that the anesthetic was also nc included in the DAWN list of agents mentioned more than ten times by medical examiners as drugs found in the body after fatal incidents. Lilly submitted its comments in response to a July I Federal Register notice announcing that the World Health Organization (WHO) had requested information on 31 substances, 16 of which are marketed in the U.S.. WHO will consider whether to recommend that the agents be placed under internatl. scheduling controls. FDA noted that it would not be making recommendations as to whether any of the drugs should be subjected to internatl. control until WHO makes official recommendations to the Commission on Narcotic Drugs. Those recommendations are expected to be made in 1986 following the WHO Expert Cmte. on Drug Dependence meeting April 21-26, 1986. Methohexital is currently a Schedule IV substance in the U.S. and, as such, is subject to "prescription refill requirements, export and import permit controls, labeling, record keeping and inventory requirements, and transfer only between ]Drug Enforcement Administration[ registrants, except for administration to patients," Lilly stated in its comments. "Because methohexital is normally administered by and under the control of a health professional and in effect is generally not available for self-administration, its potential for abuse is limited," Lilly asserted. Noting that "the company has not received reports of clandestine manufacturing, illicit trafficking or significant problems of abuse," Lilly maintained that it "is unaware of any need for internatl. controls of methohexital." Of the 16 U.S. marketed substances WHO has requested information on, methohexital is the only substance which is not controlled under Schedule III. The other 15 substances are: allobarbital, alphenal, aprobarbital, butalbital, butobarbital, cyclopentobarbital, hexobarbital, metharbital, probarbital, sodium thiobutabarbital, talubtal, thiabarbital, thiamylal sodium, thiopental sodium, and vinbarbital.

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