Other safety alerts
|
| |
| Canada: Summary Safety Review: Methimazole: Assessing the potential risk of inflammation of the blood vessels (vasculitis) |
| |
Health Canada announces that it reviewed the potential risk of vasculitis with the use of methimazole. Vasculitis is an inflammation of blood vessels that may prevent blood from reaching organs in the body. The safety review was initiated when Health Canada became aware that the United States Food and Drug Administration updated the product safety information for methimazole with new information on the risk of vasculitis.
Health Canada reviewed 13 international case reports of vasculitis in patients receiving methimazole. Of the 13 case reports, 11 reports showed a possible link to methimazole use, one report showed a slightly stronger link and one report was unlikely linked to methimazole use. Health Canada also assessed 22 articles from the published scientific literature. Many of them suggested that there was a potential risk of vasculitis with methimazole use but the frequency of the risk was considered very rare (less than one person suffered from vasculitis out of 10,000 taking methimazole).
Health Canada's review concluded that there is a link between the risk of vasculitis and use of methimazole. Health Canada is working with the manufacturers to update the Canadian safety information on methimazole products to inform about this 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=SSR00237
In Hong Kong, there are 2 registered pharmaceutical products containing methimazole (also known as thiamazole). Both products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to methimazole. The risk of vasculitis associated with the use of methimazole 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.
Ends/Wednesday, Apr 22, 2020
Issued at HKT 15:00
|
| |
