Health professionals are advised that the Product Information (PI) documents for sertraline have been updated to include microscopic colitis as a potential adverse effect of unknown frequency based on post-marketing experience.
Sertraline is a selective serotonin reuptake inhibitor (SSRI) marketed in Australia under the brand name Zoloft and multiple generic brands. It is indicated for:
children and adolescents (aged 6 years and over)
treatment of obsessive compulsive disorder (OCD)
treatment of major depression, OCD and panic disorder
treatment of social phobia (also called social anxiety disorder) and prevention of its relapse
treatment of premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria.
Microscopic colitis is now included in the list of 'Gastrointestinal disorders' in the 'Adverse effects (Post-marketing experience)' section in Australian sertraline PI documents.
Microscopic colitis is a type of inflammatory bowel disease. It is characterised by non-bloody, watery diarrhoea. Other symptoms may include faecal urgency, incontinence and nocturnal episodes.
There are two different types of microscopic colitis - lymphocytic colitis and collagenous colitis. They present with the same symptoms but differences are found on histological examination. Diagnosis requires a biopsy.
Similar information about microscopic colitis has been added to product information in Europe based on a recommendation from the European Medicines Agency after reviewing pharmacovigilance data and the medical literature.
Cases in Australia
To 20 May 2021, there are six cases of microscopic colitis suspected to be related sertraline reported to the TGA and included in our Database of Adverse Event Notifications (DAEN). Of these, five were described as lymphocytic colitis1 and one as collagenous colitis.
When to be concerned?
Diarrhoea is listed as a very common adverse reaction associated with sertraline and occurs in at least 10% of people who start taking the medicine. If diarrhoea is severe or prolonged, microscopic colitis should be taken into consideration.
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