Other safety alerts
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| Canada: Summary Safety Review: Propyl-Thyracil (propylthiouracil): Assessing the potential risk of birth defects |
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Health Canada announces that it reviewed the potential risk of birth defects in babies whose mothers used propylthiouracil (PTU) during pregnancy after becoming aware of international reports that suggested that such a link existed.
At the time of the review, Health Canada had received 12 reports (4 Canadiana and 8 international) of birth defects in babies whose mothers were treated with PTU during pregnancy. Of these 12 reports, 7 were found to be possibly linked to PTU use; 4 were not likely to be linked; and one report did not have enough information to be assessed. No definitive link was found between the birth defects in these cases and use of PTU in pregnant women.
Health Canada also looked at the published literature and found a total of 22 relevant studies where PTU was used during pregnancy. Eighteen studies were in people and 4 were in animals. These studies had opposing results as to whether PTU was linked with birth defects. The review of these studies did not find sufficient evidence that there is a risk of birth defects with the use of PTU during pregnancy.
Health Canada's review of the available information could not confirm or exclude a link between the risk of birth defects in babies and use of PTU in women during pregnancy. However, health care professionals and patients should know of this potential risk. Health Canada is working with the manufacturers to update the Canadian product safety information for PTU products to inform health care professionals and patients about this potential risk.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00235
In Hong Kong, there are 5 registered pharmaceutical products containing propylthiouracil. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to propylthiouracil. The risk of birth defects following maternal use of propylthiouracil is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Monday, Apr 6, 2020
Issued at HKT 15:00
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