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MW 30 April 2014

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maltatoday, WEDNESDAY, 30 APRIL 2014 News 4 No heart deaths caused by anti-nausea drug reported, says medicines regulator MIRIAM DALLI NO deaths were reported in Malta as a result of domperidone use, the medicines regulator told MaltaTo- day. Domperidone – more commonly known by the brand name Motil- ium – is a prescription drug used for the treatment of nausea and vomiting and also for the manage- ment of symptoms such as bloat- ing, discomfort and heartburn. However, the European Medi- cines Agency has now called for a restricted use of domperidon- containing medicine, after a care- ful evaluation of the available evi- dence on the benefits and risks of such medicines. Prescribed for two million peo- ple in the United Kingdom alone, the UK's Medicines and Health- care 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 dom- peridone. 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 participat- ing 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 Decen- tralised Procedures (CMDh) – a medicines regulatory body repre- senting the EU Member States – agreed to restrict the use of dom- peridone-containing medicines. "These medicines should only be used to relieve symptoms of nau- sea and vomiting; doses and length of treatment should be restricted and they should be adjusted care- fully 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 profession- als 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 recom- mendations agreed at European level, that all the products can con- tinue to be prescribed and used in line with the published advice. "Also, in line with these recom- mendations, the Medicines Au- thority has issued updated safety information for health care pro- fessionals and patients," the medi- cines regulator said. Product information, including the package leaf let of the medi- cines, will also be updated by the companies responsible for all prod- ucts containing domperidone. Patients taking these medicines, which are prescription-only medi- cines, 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 ref lux. Consultant paediatrician Victor Grech advised patients to always seek medical advice before taking medication. "Most importantly, do not sug- gest 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 medi- cines authority had issued guide- lines to the healthcare profes- sionals on the administration of domperidone: "We know we have to be cautious when administer- ing medicine. I would only rec- ommend Motilium in cases of persistent vomiting, and never for prolonged usage." Information on 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 body- weight 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 tak- ing 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 3.8% 'record increase' in female labour participation MIRIAM DALLI FEMALE participation in the work- force has increased by a record 3.8% during the third quarter of last year, reaching 47.8%, the finance minis- ter said yesterday. But compared to the female par- ticipation in the European Union, Malta lags severely behind. Finance Minister Edward Sciclu- na however said that the NSO data was "encouraging": "The increase is very encouraging and it shows that we are catching up fast. We hope that with the social measures being enacted, this will accelerate in the years to come," Scicluna told a meeting of the In- ternational Council of Women. Scicluna said the Maltese female workforce represented a resource that has not been fully tapped: "As a long-term University faculty mem- ber, it pains me to see more women than men following our university degree programmes, only to find later that more men than women remain in the workforce. So much talent and training being under- utilised." But while the majority of students graduating from the University are female, yet decision-making posi- tions and top posts are male-dom- inated. The finance minister reiterated the government's free childcare service initiative was crucial to address this situation, facilitating women's access to work by provid- ing quality and affordable childcare that will alleviate family burdens. "It allows women to reach their potential while knowing their chil- dren are in safe hands. Of course, childcare centres shouldn't simply be places to park children. I know my colleague, the Education Minis- ter, has been working hard to intro- duce an element to stimulate chil- dren so that they gain a worthwhile experience, learning and interact- ing with other children," he said. The Labour administration has taken steps to provide free child- care in a bid to encourage more mothers to join the workforce, while a directory of Maltese female professionals is in the process of be- ing updated. However, only one in four govern- ment board members are women, EU statistics show. Prime Minister Joseph Muscat claims that the ap- pointment of a female president and the increased number of fe- male members of the judiciary will serve as role models for upcoming generations.

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