Diclectin Drama (Brand vs Generic)

This started back in September 2017, with the most recent (and final) discussion in December 2017.

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Kenny

For now let's put aside the conversation of the efficacy of Diclectin (doxylamine – pyridoxine). For more information on its efficacy, you can read a SOGC article here: sogc.org/news-items/index.html?id=157

It all started with a letter from the Society of Obstetricians and Gynaecologists of Canada (SOGC) on September 7 2017. Here are some excerpts:

​"[The SOGC] is very concerned about Health Canada’s recent approval of a generic “Diclectin” (doxylamine – pyridoxine) which contains the artificial sweetener mannitol for the treatment of nausea in pregnancy. "

"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."

"We are aware that the amount of mannitol is likely small, but we have searched the literature and find absolutely no evidence of safety, where we do find evidence that mannitol accumulates in the fetus. "

The full SOGC letter is attached below. 

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Health Canada replied on October 13 2017, and here are a few excerpts:

"Health Canada would like to reassure Canadians that, based on its evaluation of the evidence available to date, consumption of small quantities of sugar substitutes, including mannitol, during pregnancy does not pose a health risk."

"Mannitol has a long history of safe consumption in many products commonly used and consumed by pregnant women, including folic acid supplements, vitamins, candy and baked goods. Mannitol also occurs naturally in many foods, including cauliflower, mushrooms, snow peas, and peaches.The amount of mannitol used as a non-medicinal ingredient in medications is extremely small—usually less than 0.25 grams. The amounts of mannitol found naturally in foods are much higher."

​The full Health Canada response is attached below.

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Ultimately, it seems that SOGC was re-assured by the statement. Here was their response on December 7 2017:

"The SOGC recently wrote to Health Canada to voice our concern about the recent approval of a generic “Diclectin” (doxylamine-pyridoxine). In response to our letter, Health Canada has reassured us that they stand by the safety of the generic product. Health Canada also reassured us that they will continue to monitor the safety of mannitol and the safety of all health products, including those indicated for use by pregnant women. As an organization that advocates for patient safety and evidence-based research, we believe pregnancy-specific test is best practice. However, we have accepted the reassurance of Health Canada."

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