Health Canada be summoned to intervene urgently

News 1 October, 2017
  • Valerie Bidégaré

    Sunday, 1 October 2017 00:00

    Sunday, 1 October 2017 00:00

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    The sale of two generic drugs for the treatment of nausea and vomiting during pregnancy concerned about the Association of obstetricians and gynecologists of Quebec (AOGQ) that calls for an “urgent intervention” on the part of Health Canada.

    The two products are generic versions of the original drug Diclectin, one of the remedies most frequently prescribed for the treatment of nausea and vomiting of 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 the pregnant woman and her unborn baby.

    “Mannitol is considered to be a diuretic,” says Dr. Simard. “Here we have patients who have nausea and vomiting of pregnancy. They have had enough of throwing up and having trouble staying hydrated, they should not be losing water by the kidneys more “, adds the professional who deplores the lack of analysis carried out with pregnant women and women in general.

    Tested it on men

    “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,” says Dr. Simard. “We do not know what is the amount 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 “, raises it.

    To this effect, the AOGQ has sent a letter to Health Canada on September 19, to call for ” urgent intervention “, but also a moratorium on the two generic drugs until they are ” submitted to an examination of comprehensive security by canadian experts in maternal-fetal medicine “.

    “We would like that the two companies are producing, with their medications, studies to tell us that it is safe for the pregnant woman “, argues the president of the AOGQ. “Here, I am not able to tell you, because this is not established in the literature. “