Information Update - Mannitol as a non-medicinal ingredient in medications for pregnant women
- Starting date:
- October 13, 2017
- Posting date:
- October 13, 2017
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Product Safety
- General Public
- Identification number:
October 13, 2017
For immediate release
OTTAWA – Health Canada is aware of recent concerns around the use of mannitol as a non-medicinal ingredient in medications for use by pregnant women. 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 is a type of sugar commonly used as a non-medicinal ingredient in medications, such as tablets or capsules, to help in the manufacture of the product. Non-medicinal ingredients are evaluated for safety. They are used, for example, to help hold a tablet together or give it colour.
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. For example:
- cauliflower has about 2.6 grams of mannitol per 100 grams
- mushrooms have about 2.6 grams of mannitol per 100 grams
- snow peas have about 1.2 grams of mannitol per 100 grams
- peaches have about 0.5 grams of mannitol per 100 grams
Health Canada assesses all medications, including generic medications, for safety, quality and effectiveness before authorizing them for sale in Canada. This includes assessing scientific evidence for the safety of non-medicinal ingredients, as well as carefully considering whether clinical trial data appropriately supports authorization of the medication for specific populations, such as pregnant women.
Pregnant women should speak to their health professional if they have questions about medications they are taking. Health Canada continues to monitor the safety of authorized medications once they are on the market in Canada. Should any new safety concerns arise, the Department will take prompt action and inform Canadians as appropriate.
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