Letter to Health Canada regarding the recent approval of a generic "Diclectin" (doxylamine - pyridoxine) containing mannitol
The SOGC has written to Health Canada voicing our concern about the recent approval of a generic "Diclectin" (doxylamine-pyridoxine), which contains the artificial sweetener mannitol, for the treatment of nausea in pregnancy.
We will also be writing to the provincial and territorial governments across Canada to raise awareness about this potential risk and will keep members informed of any updates on this issue.
From the letter:
"While doxylamine and pyridoxine are currently referenced as pregnancy-safe drugs, following extensive testing in pregnant women, and with many years in the Canadian market, mannitol is contra-indicated for pregnancy by the FDA. In addition, because there is no controlled data on the use of mannitol in human pregnancy, we believe the decision to allow these generics as a safe Class A prescription product for Canadian women in pregnancy sets a regrettable and worrisome precedent. This action will, no doubt, undermine the confidence of women and physicians in the decisions of those in a position to protect them with safe medications for use in pregnancy."