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Sertraline and microscopic colitis

Medicines Safety Update

23 June 2021

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)
  • adults
    • 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.

See the latest PI documents for sertraline products for further information.


Reference


What to report? You don't need to be certain, just suspicious!

The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.

We particularly request reports of:

  • all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
  • all suspected medicines interactions
  • suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

Reports may be submitted:

For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.

Acting Editor: Dr Catherine Brogan

Deputy Editor: Mr Michael Pittman

Contributor: Ms Renae Mura and Dr Fiona Mackinnon