The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety update for anti-emetic medicine domperidone after receiving a “small number of reports” about ”severe episodes of hypertension in patients with phaeochromocytoma”.
The regulator said on July 21 that domperidone is “now contraindicated in patients with confirmed or suspected phaeochromocytoma”, a rare tumour of the adrenal gland, and that these patients should stop taking the drug “immediately and be switched to an alternative treatment”.
It also advised healthcare professionals to “be aware that administration of domperidone can unmask phaeochromocytomas”.
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“If a patient taking domperidone has an episode of severe hypertension, consider further investigations for phaeochromocytoma,” it said.
The regulator added that domperidone “should be used at the lowest effective dose for the shortest possible duration”, while “maximum treatment duration should not usually exceed one week”.
And it said patients should “seek medical attention immediately” if they experience symptoms of hypertension, including but not limited to “persistent headache, blurred vision, shortness of breath and chest pain”.
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The safety update follows a recent European review of safety data for domperidone, which “identified an association between domperidone and episodes of severe hypertension in patients with phaeochromocytoma following a small number of reports of this event”.
The MHRA said the findings of the review “were considered by the UK’s Pharmacovigilance Expert Advisory Committee of the Commission on Human Medicines, who agreed with the recommendations and advised that the MHRA inform healthcare professionals and patients of this new contraindication”.
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While the MHRA has not received any UK Yellow Card reports relating to the issue, it said four reports were considered in the European review.
It noted that phaeochromocytomas are “rare, with a global prevalence of 19.8 per 1,000,000 people”, and that total prescribing of domperidone “averages 222,000 items per year across NHS England”.
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It comes after the MHRA updated safety advice for hair loss drug finasteride and prostate drug dutasteride in May after reviewing evidence on the risks of “sexual dysfunction, depression and suicidal thoughts”.
And it follows the medicines regulator limiting the use of some nasal decongestant sprays to a maximum of five days “due to adverse effects following prolonged use”.
