MHRA and FDA warnings against quinine for leg cramps

15th July 2010

The June issue of the MHRA drug safety update reminds health professionals about the risks of serious undesirable effects with the use of quinine. It states that quinine should not be a routine treatment for nocturnal leg cramps. It should only be considered when cramps cause regular disruption of sleep, when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out and when non-pharmacological measures have not worked (e.g. passive stretching exercises). After an initial trial of 4 weeks, treatment should be stopped if there is no benefit.
In the US, the FDA has approved a risk management plan (REMS) to warn against the off-label use of quinine sulphate (Qualaquin) for night time leg cramps following continued reports of serious side effects. The FDA states that quinine should not be used for night time leg cramps and requires that patients be given a medication guide explaining what the drug is and is not approved for, as well as the potential side effects. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider letter warning of the risk of serious and life-threatening haematological reactions.
Further advice and information can be obtained from the links below.

MHRA Drug Safety update June
FDA alert for quinine