Safety update:

Potential risk of microscopic colitis associated with the use of sertraline.

Sertraline is antidepressant medication marketed under the brand name Zoloft and multiple generic brands. It acts as a selective serotonin re-uptake inhibitor (SSRI) with the below therapeutic indications:

  • Treatment of obsessive compulsive disorder (OCD) in children and adolescents (aged 6 years and over).
  • Treatment of major depression, OCD and panic disorder, social anxiety disorder, premenstrual dysphoric disorder (PMDD) in adults.

Health Authority

Therapeutic Goods & Administration (TGA) – Health authority of Australia.

Important note for Healthcare professionals:

The product labels of sertraline is being updated with the new adverse reaction microscopic colitis.

  • This reaction is a type of inflammatory bowel disease with major manifestation of diarrhea.
  • Though diarrhea is listed as a very common adverse reaction for sertraline product which occurs in at least 10% of people using this medicine, inform your patients and their respective care providers to monitor for any symptoms of diarrhea which is severe or prolonged. Then microscopic colitis should be taken into consideration.

Important note for Public (Patients/patient care providers):

Be aware of this new adverse reaction – microscopic colitis for sertraline, and be cautious about the following symptoms of side effect:

  • Non-bloody, watery diarrhea
  • Fecal urgency
  • Lack of voluntary control over urination or defecation & nocturnal episodes.

Inform your respective doctor or healthcare professional about your underlying medical conditions and concurrent use of other medications, also if any risk factors (described above), even if they haven’t asked about the same. This facilitates the effective assessment of benefit-risk ratio and identification of suitability of the medicine for use/or looking for alternative medicine with the favorable benefit risk ratio.

Voluntary ADR reporting:

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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