Strong mother-baby bond: Health Canada endorses important safety information regarding Domperidone
Health Canada disapprove the use of Domperidone for mothers. Health Canada states changes to QT interval can lead to serious abnormal heart rhythms which can be harmful to lactation.
(PRWEB) June 22, 2012
Generic drug Domperidone makers and users find themselves in yet another controversy. This time Health Canada and Domperidone makers have issued a warning against the drug. They believe that the drug Domperidone has been associated with heart related problems that could cause death.
Domperidone is manufactured by many pharmaceutical companies in Canada. The drug is an approved medication to treat vomiting, nausea and other symptoms of stomach glitches such as Gastro paresis or gastritis in many countries. ℠Off label´ the drug is also prescribed to stimulate lactation or milk production.
Health Canada notification comes after almost a year after the FDA turned down the manufacturer Janssen pharmaceutical´s application for the approval. FDA expressed the concerns with the reports of cardiac problems and cases of death associated with the intravenous use of the drug Domperidone. FDA warning can be followed on FDA site which was published on June 7 2004. FDA on it site states that the drug can cause risks to infants and mothers as Domperidone gets excreted to the breast milk. The FDA stand was critically censured by many doctors in America and many termed it as a “political statement”. Dr Jack Newman in an open letter which can be found here said that, “It´s a shame for women in US to be deprived of this drug”. Dr Newman´s view was advocated by many doctors in America and endorsed the use of the drug to promote milk production in breastfeeding mothers.
Health Canada has yet again ignited the controversy. Health Canada has urged the users to seek medical guidance. The safety alert advises the user taking Domperidone not to stop taking the medicine or change the dose before consulting the doctors. Motilium is the brand for this medicine.
The safety alert doesn´t find enough support from the doctors and researchers in Canada. The team of doctors and researchers has issued a joint consensus statement to use Domperidone as a drug to support lactation. The statement does not endorse the Health Canada stand on the drug Domperidone and has raised severe questions on the basis of the Health Canada study on which the alert is based.
The team of doctors has questioned the basis of Health Canada advocated warning. According to the statement the safety notification was based on data derived from public health databases: one in Saskatchewan and other in Netherland. The experts believed that the information was gathered from entirely different population than those which would be using the drug. They also questioned the average age of the patients involved in the study. The studies were carried on septuagenarians. Many of these people were already suffering from diseases like congestive heart failures, high blood pressure and coronary artery disease. This is entirely different from the population which is advised to take Domperidone and believed that the trends are extrapolated to the population largely comprised of healthier women definitely not in their 70´s. The statement has slammed the Health Canada report by questioning the basis of the report. Domperidone is recommended to mitigate the symptoms of gastrointestinal disease. According to the team of experts the symptoms of heart disease can sometimes mimic the symptoms of gastritis, for relief from immediate gastric problems nexium or prevacid are a good solution after consulting with your doctor. The symptoms of gastritis may have also created doubts in the minds of surveyed individuals. The experts also believed that there is limitation to the study as key information is missing from the report. They believed that key information pieces are unavailable including,”smoking status and use of non-prescription drugs” both of which can be important factors in determining the trends and results of the study. The statement endorses the viewpoint that,´´ breastfeeding mothers using the drug Domperidone do not come under the same demographics as the individuals involved in the Health Canada study. ℠´ The statement slammed the Health Canada warning and termed it as ℠over reaction´ and believe that caution is required while using the drug but complete abandon is not at all required on the basis of this security alert based on handful of patients.
The Canadian experts expressed their faith in three decade long track record of Domperidone to support breastfeeding. There was strong consensus among the group that medical literature is full of health risks associated with mothers and babies deprived of breastfeeding. They believed that these health risks outweigh and outnumber the unlikely risks of Domperidone drugs.
The Health Canada notification has once again bewildered the mothers in Canada but these experts term this notification as a classic case of overreaction and have recommended the use of Domperidone to promote lactation. Domperidone is available at Canadian online pharmacy with a valid prescription only.
For the original version on PRWeb visit: http://www.prweb.com/releases/prwebdomperidone/motilium/prweb9626272.htm