No heart deaths caused by anti-nausea drug reported - medicines regulator

No deaths were reported in Malta as a result of domperidone use, the medicines regulator told MaltaToday.

Domperidone – more commonly known by the brand name Motilium – is a prescription drug used for the treatment of nausea and vomiting and also for the management of symptoms such as bloating, discomfort and heartburn.

However, the European Medicines Agency has now called for a restricted use of domperidon-containing medicine, after a careful evaluation of the available evidence on the benefits and risks of such medicines.

Prescribed for two million people in the United Kingdom alone, the UK’s Medicines and Healthcare Products Regulatory Agency has now ordered for the drug to be restricted for those with sickness and nausea only.

It was found that 57 people in the UK are known to have died from heart problems while taking domperidone.

The advice was originally issued by the European Medicine Agency and has been taken on board by the Malta Medicines Authority (MMA) as well.

The MMA has been participating actively in the discussions at European level on the safety of domperidone over the past few months. 

The Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) – a medicines regulatory body representing the EU Member States – agreed to restrict the use of domperidone-containing medicines.

“These medicines should only be used to relieve symptoms of nausea and vomiting; doses and length of treatment should be restricted and they should be adjusted carefully by the patient’s weight where available for use in children,” the CMDh said.

In comments to MaltaToday, a spokesperson for the medicines regulator confirmed that advice for local health care professionals was issued in March this year, giving information on the ongoing discussions and recommendations to prescribers on the safe use of the product.

“This included a restriction on some of its uses, length of use and doses to be prescribed,” the spokesperson said.

The MMA has carried out an evaluation of the current products on the market in Malta and it was concluded, in line with the recommendations agreed at European level, that all the products can continue to be prescribed and used in line with the published advice. 

“Also, in line with these recommendations, the Medicines Authority has issued updated safety information for health care professionals and patients,” the medicines regulator said.

Product information, including the package leaflet of the medicines, will also be updated by the companies responsible for all products containing domperidone. 

Patients taking these medicines, which are prescription-only medicines, are encouraged to discuss their treatment with their doctor or pharmacist.

Motilium has been used to treat nausea and vomiting since the 1980s and is widely prescribed by GPs for babies with severe reflux.

Consultant paediatrician Victor Grech advised patients to always seek medical advice before taking medication.

“Most importantly, do not suggest any medicines to neighbours. Whether it’s for yourself, for an adult or for a child, always seek professional advice,” he said.

Grech confirmed that the medicines authority had issued guidelines to the healthcare professionals on the administration of domperidone: “We know we have to be cautious when administering medicine. I would only recommend Motilium in persisting vomiting and never for prolonged usage.”

Domperidone

• Domperidone is a medicine that has been used for various stomach and digestive problems. There have been concerns that it might increase the risk of side effects on the heart, including dangerously irregular heartbeats in some patients
• Because a review has shown that the risks of domperidone are greatest at high doses or when it is used for a longer period, the medicine should only be approved for use in low doses to treat symptoms of nausea and vomiting (feeling or being sick). Treatment should generally only be given for up to one week.
• The recommended dose in adults is 10 mg by mouth up to three times a day, or 30 mg as a suppository twice a day. Where suitable products are available for children, doses should be calculated depending on bodyweight and given with a device that allows accurate measuring. Some products will be withdrawn from the market because their strength does not match the new doses.
• There is no good evidence to support the use of domperidone for other conditions such as bloating and heartburn, and so it will no longer be authorised to treat these conditions.
• Patients with certain existing heart problems, or who are taking certain other medicines that enhance the effects of domperidone or reduce its breakdown in the body, should not take domperidone.
• Patients or carers who have any concerns should speak to a healthcare professional. Those who are taking domperidone long-term or in higher doses, or for conditions other than nausea and vomiting, should consult their doctor at their next scheduled appointment or speak to their pharmacist to discuss their treatment.

Source: European Medicines Agency