BMJ 2014;348:g1722 doi: 10.1136/bmj.g1722 (Published 24 February 2014)
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NEWS French journal calls for domperidone to be withdrawn Paul Benkimoun Paris
The independent French medical journal Prescrire has called for the drug domperidone to be withdrawn after a study it conducted estimated that the drug caused about 25 to 120 premature deaths in 2012 in France alone.
The European Medicines Agency (EMA) is due to issue an opinion on domperidone in March, but the journal believes the agency will recommend lower dosages and shorter treatment. This is not enough, believes Prescrire. “It is high time the European health authorities withdrew this drug from the market,” it said in a statement.
It added: “These measures [proposed by the EMA] are insufficient to fully protect patients and would just shift the responsibility from drug regulatory agencies onto healthcare professionals, who have enough to do without having to explain to patients that a particular drug is authorised but should not be used.” Domperidone is commonly used to treat nausea, vomiting, and reflux. But it is of modest efficacy and, because of its action on potassium channels, domperidone and neuroleptics like it increase the risk of heart rhythm disorders.
In 2005 domperidone was found to prolong the QT interval and Dutch and Canadian case control studies demonstrated an increased incidence (1.6-fold to 3.7-fold higher) of sudden death in adults exposed to this drug.
In 2011 the EMA’s pharmacovigilance working party recommended that the product information for medicines containing domperidone be updated to reflect the risk of these adverse effects. Last March the EMA, triggered by a report from the Belgian medicines agency, started a review of medicines containing domperidone. The study conducted by Prescrire was based on anonymised data from the French health insurance system.1 It found that
For personal use only: See rights and reprints http://www.bmj.com/permissions
domperidone was dispensed at least once to about three million adults in France in 2012. Using the two incidence figures from the Canadian and Dutch studies the analysis estimated that between 25 and 120 sudden deaths were attributable to domperidone in 2012. Commenting on the study, Jean-Louis Montastruc, head of pharmacology at Toulouse University Hospital, said that while domperidone may indeed have caused some sudden deaths in France it is less certain whether the data from Canadian and Dutch studies can be transposed to French patients.
Bruno Toussaint, the editor of Prescrire, acknowledged that there were a lot of limitations to the study because data on age, prescribed dosage, and associated pathologies were not available. But he believes the figures have not been overestimated.
Prescrire said that in practice the disorders for which domperidone is prescribed are often self-limiting or resolve with dietary measures. For patients who want drug therapy there are other options, such as a proton pump inhibitor for gastro-oesophageal reflux. Prescrire added: “In the rare situations in which a gastric ‘motility modifier’ appears justified, metoclopramide can be discussed, but used with great caution: at the lowest effective dose, monitoring very closely for its adverse effects, given that this drug is also a neuroleptic.” 1
Domperidone: an indication of how many sudden deaths in France could be prevented by avoiding this low-efficacy drug. Prescrire Analysis , 19 Feb 2014. http://english.prescrire. org/Docu/DownloadDocu/PDFs/domperidone_an_indication_of_how_many_sudden_ deaths.pdf.
Cite this as: BMJ 2014;348:g1722 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
News
NEWS French journal calls for domperidone to be withdrawn Paul Benkimoun Paris
The independent French medical journal Prescrire has called for the drug domperidone to be withdrawn after a study it conducted estimated that the drug caused about 25 to 120 premature deaths in 2012 in France alone.
The European Medicines Agency (EMA) is due to issue an opinion on domperidone in March, but the journal believes the agency will recommend lower dosages and shorter treatment. This is not enough, believes Prescrire. “It is high time the European health authorities withdrew this drug from the market,” it said in a statement.
It added: “These measures [proposed by the EMA] are insufficient to fully protect patients and would just shift the responsibility from drug regulatory agencies onto healthcare professionals, who have enough to do without having to explain to patients that a particular drug is authorised but should not be used.” Domperidone is commonly used to treat nausea, vomiting, and reflux. But it is of modest efficacy and, because of its action on potassium channels, domperidone and neuroleptics like it increase the risk of heart rhythm disorders.
In 2005 domperidone was found to prolong the QT interval and Dutch and Canadian case control studies demonstrated an increased incidence (1.6-fold to 3.7-fold higher) of sudden death in adults exposed to this drug.
In 2011 the EMA’s pharmacovigilance working party recommended that the product information for medicines containing domperidone be updated to reflect the risk of these adverse effects. Last March the EMA, triggered by a report from the Belgian medicines agency, started a review of medicines containing domperidone. The study conducted by Prescrire was based on anonymised data from the French health insurance system.1 It found that
For personal use only: See rights and reprints http://www.bmj.com/permissions
domperidone was dispensed at least once to about three million adults in France in 2012. Using the two incidence figures from the Canadian and Dutch studies the analysis estimated that between 25 and 120 sudden deaths were attributable to domperidone in 2012. Commenting on the study, Jean-Louis Montastruc, head of pharmacology at Toulouse University Hospital, said that while domperidone may indeed have caused some sudden deaths in France it is less certain whether the data from Canadian and Dutch studies can be transposed to French patients.
Bruno Toussaint, the editor of Prescrire, acknowledged that there were a lot of limitations to the study because data on age, prescribed dosage, and associated pathologies were not available. But he believes the figures have not been overestimated.
Prescrire said that in practice the disorders for which domperidone is prescribed are often self-limiting or resolve with dietary measures. For patients who want drug therapy there are other options, such as a proton pump inhibitor for gastro-oesophageal reflux. Prescrire added: “In the rare situations in which a gastric ‘motility modifier’ appears justified, metoclopramide can be discussed, but used with great caution: at the lowest effective dose, monitoring very closely for its adverse effects, given that this drug is also a neuroleptic.” 1
Domperidone: an indication of how many sudden deaths in France could be prevented by avoiding this low-efficacy drug. Prescrire Analysis , 19 Feb 2014. http://english.prescrire. org/Docu/DownloadDocu/PDFs/domperidone_an_indication_of_how_many_sudden_ deaths.pdf.
Cite this as: BMJ 2014;348:g1722 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
