Magazine article Drug Topics

Over and out for Theophylline OTC; Ephedrine May Follow

Magazine article Drug Topics

Over and out for Theophylline OTC; Ephedrine May Follow

Article excerpt

Over-the-counter theophylline is going, and OTC ephedrine could be next. The Food & Drug Administration said it plans to ban OTC cough-cold combination products containing theophylline, effective Jan. 29, 1996. Citing dozens of deaths and hundreds of "severe" outcomes annually due to theophylline exposure, the FDA concluded that "whether theophylline is administered as a single ingredient or in combination with other drugs, it is essential that a physician titrate theophylline dosage based on individual patient measurements of theophylline serum levels." The federal agency reaffirmed its position that theophylline should be administered under professional supervision as a prescription product.

As for ephedrine, the Drug Enforcement Administration has asked for restrictions on OTC availability because of its illegal use as a precursor to the synthesis of the street drugs methamphetamine and methcathinone. The FDA said it also has received a number of reports about OTC ephedrine abuse as a bronchodilator as well as in products that claim use as a stimulant or for weight reduction. At least 14 states have placed additional controls on ephedrine, scheduling it as a controlled substance or making it prescription only. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed

Oops!

An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.