Mannitol: Health Canada maintains that there is “no risk” for pregnant women

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QMI agency

Sunday, 15 October, 2017 06:35

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Sunday, 15 October, 2017 06:35

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Last September, the Association of obstetricians and gynecologists of Quebec (AOGQ) shared her concern regarding the sale of two generic drugs for the treatment of nausea and vomiting during the pregnancy and demanded an “urgent intervention” on the part of Health Canada as well as a moratorium on these medications.

The two products concerned are the generic versions of the original drug Diclectin, one of the remedies most frequently prescribed for the treatment of nausea and vomiting during pregnancy, and have been concocted by the pharmaceutical companies (Apotex and Pharmascience.

According to the president of the AOGQ, Fabien Simard, both of these derivatives contain mannitol, a substance in which the absence of danger has not been demonstrated in pregnant women.

“Normally, when we give drugs to pregnant women, it is necessary that the product has been tested on women and pregnant women while it has been tested on men. It is not known what is the quantity of mannitol present […] May be this is too much, maybe it is a little dust, and this is correct, but it is taken during the entire pregnancy, due to sometimes five or six tablets per day”, had indicated to Dr. Simard, the “Newspaper of Montreal”.

The AOGQ had sent a letter to Health Canada, on 19 September, calling for “urgent intervention” and a moratorium until these drugs are “subject to a review of comprehensive security by canadian experts in maternal-fetal medicine”.

In a press release, Health Canada has recently held that “according to his evaluation of the data, the consumption of small quantities of sugar substitutes, including mannitol, during pregnancy presents no risk to health.”

“Mannitol is consumed for a long time without risk and can be found in many products often used and consumed by pregnant women, as folic acid supplements, vitamins, candy, and pastries. Mannitol is also found naturally in many foods, including cauliflower, mushrooms, peas and peaches.”

According to Health Canada, the amount of mannitol used as a non-medicinal ingredient in drugs would be small, “usually less than 0,25 gram”.

Health Canada is responsible for conducting an evaluation of all the medicines, “to ensure their safety, their amount and their effectiveness” before they are authorized for sale in Canada, but also once they are on the market.