A drug of choice with a favourable risk-benefit balance and appropriate packaging: quinine-based Okimus°, sold in France as a treatment for nocturnal leg cramps, does not fulfil any of these criteria.
Quinine has a distinctly unfavourable risk-benefit balance as a treatment for cramps. Severe, sometimes fatal, adverse effects have been observed: arrhythmia, haemorrhages due to a decrease in the number of some blood cells.
The tablets are packaged loose in a bottle with no safety lid, which can easily be opened by children. The bottle’s apple-green colour is likely to appeal to children. The small, convex, round brown tablets resemble chocolate-coated sweets.
There are 40 tablets in a bottle, containing a total of 3.2 g of quinine, whereas deaths have been reported in children having swallowed just 1 g of quinine.
In approving such a "public danger", the French Health Products Safety Agency, (Afssaps) has failed to do its job. Prescrire urges doctors not to prescribe this drug, and calls on pharmacists to alert patients to the danger it represents for children.
©Prescrire July 2008
Source: "Okimus° : tout faux !" Rev Prescrire 2008 ; 28 (297) : 501.
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