It is becoming popular in the United States as an ingredient in weight-control products. Pharmacological actions of coumarins include vasodilatation, CNS stimulation, and immunosuppression. Photosensitivity seems to be a significant concern. In another article in the same issue of Federal Register, there have been many complaints registered with the FDA concerning the misuse of OTC products containing ephedrine. These products have been misused as a stimulant, for weight control, and in athletic muscle building products.
Ephedrine is also the substance used for the illicit production of crystalline methamphetamine.
The agency will accept any comments on the proposed rule until August 28, 1995. A third H2 antagonist will be marketed for OTC sales. When final approval is given, it will join famotidine and cimetidine as OTC agents. The drug, which is a biphosphonate similar to etidronate, is proposed for the treatment of osteoporosis in postmenopausal women. The committee did express concern that there is need for more long-term studies to confirm its safety and effects.