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Ciba-Geigy’s Q-Vel

Executive Summary

Ciba submits additional study in support of its OTC quinine sulfate product for nocturnal leg cramps. The study, by Richard Aster, MD, Medical College of Wisconsin, suggests that rare (one in 40,000, according to Ciba) serious adverse reactions to quinine would not be prevented by having Q-Vel available Rx-only. The Health Research Group petitioned FDA in 1988 to ban OTC sales of quinine sulfate.
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PS017261

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