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Eskatrol

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Eskatrol was an amphetamine weight loss agent which was removed by the U.S. Food and Drug Administration (FDA) in 1981 after its manufacturer,[1] SmithKline & French (SKF),[2] failed to prove the therapeutic effectiveness (Emax) of the medication. At the time it was among the 200 most widely prescribed drugs in the United States. A couple of others included Dexamyl and Desbutal pills.[1] Eskatrol contained dextroamphetamine sulfate (Dexedrine)[3] and prochlorperazine (Compazine), a typical antipsychotic.

In August 1970 the FDA sought to limit the use of stimulants by calling for changes in labeling which decreased the number of allowable claims and intensified the warnings about possible hazards. The FDA Commissioner, Charles C. Edwards, criticized the pharmaceutical industry for not helping to prevent the drug abuse of amphetamines. Thomas M. Rauch, president of SKF Laboratories, responded that his company had long promoted stricter abuse legislation and tighter controls on production and distribution. SKF also manufactured dextroamphetamine sulfate (Dexedrine) and racemic amphetamine sulfate (Benzedrine) pills. The FDA then established restrictions onto amphetamine treatment claims by manufacturers, limiting the total number of amphetamine indications to only three medical uses. These were specified to be the two rare conditions of narcolepsy and hyperactivity with the third permitted indication being for appetite suppression among obese patients. However, usage of amphetamines as anorectic agents will only be indicated for short-term obesity treatment not to exceed a few weeks.[4]

See also

References

  1. ^ a b U.S. Review of Prescription Drugs Ends, The New York Times, September 16, 1984, Page 52.
  2. ^ Advertising:Menley & James Turns To Love 1969 Style, January 26, 1969, Page F16.
  3. ^ Pharmacist Arrested on Drug Charge, Los Angeles Times, July 16, 1975, Page A3.
  4. ^ Pep Pill Makers Accused By F.D.A., The New York Times, August 6, 1970, Page 1.