ADR that result in revision of patient information
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| Australia: Sertraline and microscopic colitis |
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Therapeutic Goods Administration (TGA) announces 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.
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.
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 the Database of Adverse Event Notifications (DAEN). Of these, five were described as lymphocytic colitis and one as collagenous colitis.
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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/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 2 cases of adverse drug reaction related to sertraline, but these cases are not related to microscopic colitis. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Jun 23, 2021
Issued at HKT 16:00
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