7 November 2018 - Deborah Wilkes
The Dutch Medicines Evaluation Board (MEB) has banned OTC sales of Mylan's Inhibin (hydroquinine hydrobromide) following concerns about cardiovascular safety.
The regulatory agency is changing the status of Inhibin from a non-prescription medicine with pharmacy-only status to a prescription-only medicine.
Inhibin was first authorised as a medicine in the Netherlands in 1990. Tablets containing 100mg of the active ingredient are marketed as a treatment for nocturnal leg cramps.
The MEB said new scientific studies suggested use of hydroquinine was associated with an "increased risk of serious cardiac arrhythmias".
Two published studies
The regulatory agency said two published scientific studies indicated that quinine was associated with "increased mortality". The risk of side-effects to the heart – including death – appeared to be greater with long-term use and with patients who had certain cardiac arrhythmias, it added.
Quinine and hydroquinine had similar effects in the body, said the MEB, so it was likely that hydroquinine was also associated with a risk of cardiac arrhythmias.
The MEB added that one study indicated that for every 100 patients using quinine for one year at least one person extra died.
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