其 他 安 全 警 示
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| Singapore: Update of package insert: New safety information on use of Zoloft (sertraline) in pregnancy (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Pfizer PFE Pte Ltd to inform healthcare professionals that the package inserts of Zoloft (sertraline) have been updated to include new safety information pertaining to its use in pregnancy. The new safety information includes a statement that observational studies have provided evidence of an increased risk (< 2-fold) of post-partum haemorrhage following exposure to selective serotonin reuptake inhibitors (SSRIs), including sertraline, especially within the month prior to birth.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/update-of-package-insert-new-safety-information-on-use-of-zoloft-(sertraline)-in-pregnancy
In Hong Kong, there are 20 registered pharmaceutical products containing sertraline, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to sertraline, but these cases are not related to postpartum haemorrhage. Related news on the risk of postpartum haemorrhage associated with the use of selective serotonin reuptake inhibitors (SSRIs), including sertraline, was previously issued by the Medicines and Healthcare products Regulatory Agency of United Kingdom, and was posted on the Drug Office website on 8 Jan 2021. Letters to inform local healthcare professionals were issued by the DH on the same day. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Jul 9, 2021
Issued at HKT 14:00
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