Legal News

Over-the-counter (OTC) drug domperidone – used to treat vomiting and heartburn – is facing restrictions after an EU investigation focused on the deaths of nearly 60 patients who suffered cardiac events while taking the medication.

Around two million people in Britain regularly take domperidone for heartburn – and thousands of holidaymakers rely on the drug to treat holiday food poisoning or sickness with associated diarrhoea on holidays abroad.

In America, the US Food and Drug Administration (FDA) warned in 2004 that domperidone should not be used by women to boost milk supply when breast-feeding because of reported heart conditions such as arrythmias and heart attacks.

Breast-feeding mothers in the US had been buying domperidone from Internet pharmacies.

The FDA also received reports of cardiac events linked to intravenous use of domeperidone.

The EU began an investigation into domperidone in March 2013 because of reports of cardiac events associated with use, both intravenously and in tablet form.

Drug regulators in Belgium first alerted the European Medicines Agency (EMA) about the heart risks associated with domperidone. The EMA is the EU’s equivalent of the FDA in America.

The EMA’s investigation revealed 57 people have died from cardiac events while taking the drug – and 342 patients have reported serious side effects.

Domperidone can cause sleep problems and anxiety and it is now thought it exerts some influence on the electrical activity and rhythm of the heart.

In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) will now review its guidelines on prescribing drugs like Motilium, which contain domperidone.

Babies can be prescribed the drug for severe cases of reflux – domperidone is also used to help ease food along the digestive tract.

Dr Sarah Branch of the MHRA told The Daily Mail:

“There is no need to stop taking your medicine. However, if you have an underlying heart condition or have any other questions, please speak to your doctor or pharmacist at your next routine visit.

“The review concluded that the benefits outweigh the risks of using domperidone when used to treat nausea and vomiting – but that there should be restrictions on its use.

“It should no longer be used for symptoms of abdominal discomfort such as heartburn and feelings of fullness.”

Anyone with a heart condition or a family history of heart disease should consult their GP before taking medications containing domperidone or giving it to relatives to treat holiday food poisoning or travel sickness.

Duncan Lewis Personal Injury Solicitors for Holiday Accidents & Illness

Duncan Lewis personal injury solicitors can advise on making no win no fee claims for Holiday Accidents & Illness, including holiday food poisoning infections such as:

• Campylobacter
• Cryptosporidium
• Dysentery
• E.coli
• Listeria
• Norovirus
• Salmonella
• Shigella.

Under the Package Travel Regulations 1992, holidaymakers have three years from the date of the illness or injury to make a compensation claim.

For expert legal advice on Holiday Accidents & Illness Claims, contact Duncan Lewis Personal Injury Solicitors on 020 7923 4020.