ADR that result in revision of patient information
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| Singapore: Sertraline and microscopic colitis |
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Health Sciences Authority (HSA) is advising healthcare professionals on the potential risk of microscopic colitis associated with the use of sertraline.
Microscopic colitis is a rare inflammatory disorder of the colon. It presents with chronic, non-bloody diarrhoea, abdominal pain, weight loss and fatigue. It can be divided into two subtypes, namely lymphocytic colitis or collagenous colitis, which are clinically indistinguishable but have different histopathologic features. Both subtypes are typically characterised by a marked and diffuse excess of lymphocytes interspersed among the surface colonocytes and within the lamina propria. In collagenous colitis, a subepithelial collagen band can be seen in the colon on biopsy in addition to increased intraepithelial lymphocytes. The exact mechanism of microscopic colitis is poorly understood; an inflammatory mechanism triggered by environmental factors such as an infection, toxin or drugs has been suggested.
In 2013, a Spanish prospective case-control study which investigated the epidemiological risks factors in microscopic colitis found sertraline to be associated with an increased risk for lymphocytic colitis. The study included 120 patients with collagenous colitis, 70 with lymphocytic colitis and 128 controls from teaching and community hospitals across Spain from Mar 2007 to May 2010. Drug exposure before the onset of diarrhoea (for cases) or at study recruitment (for controls) was recorded for medicines taken ≥ 3 days per week for ≥ 2 weeks. Of the patients recruited, seven lymphocytic colitis cases and none of the controls took sertraline, contributing to a statistically significant association between sertraline intake and lymphocytic colitis [odds ratio 17.5 (2.0-149.2)]. These findings were similar to those from an earlier case-control study and were in line with the documented association of sertraline with high likelihood of triggering microscopic colitis.
Three case reports of microscopic colitis related to the use of sertraline described patients who presented with prolonged non-bloody diarrhoea lasting from over 20 days to three months, resulting in substantial weight loss of up to 20 kg in one report from the literature. In all three cases, microscopic colitis associated with sertraline was diagnosed based on temporal association with sertraline initiation and biopsies from the colon and/or rectum that revealed an increase in intraepithelial lymphocytes, which is characteristic of the condition. All the patients recovered upon discontinuation of sertraline.
To date, HSA has received five ADR reports of diarrhoea associated with the use of sertraline, none of which involved microscopic colitis.
Based on post-marketing experience, the association of microscopic colitis with sertraline use has been reported overseas and in published literature. HSA is working with the product registrants of sertraline-containing products to update the local package insert to include microscopic colitis as an adverse event that has been observed in the post-market setting.
While microscopic colitis related to the use of sertraline can result in severe prolonged diarrhoea and substantial weight loss, published case reports revealed that the condition resolved progressively following swift cessation of sertraline . Healthcare professionals are advised to consider the possibility of this adverse event in patients on sertraline who present with prolonged or severe diarrhoea.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/sertraline-and-microscopic-colitis
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 3 cases of adverse drug reaction related to sertraline, but these cases are not related to microscopic colitis. Related news was previously issued by Australia Therapeutic Goods Administration, and was posted on the Drug Office website on 23 Jun 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/Tuesday, Oct 19, 2021
Issued at HKT 15:00
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