Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI) are antidepressant class of medications used in the treatment of depression. They act by increasing the levels of serotonin and norepinephrine in the brain for therapeutic effect.

United Kingdom health authority – Medicines and Healthcare products Regulatory Agency (MHRA) released a drug safety update for SSRI and SNRI class of medicines for a small increased risk of postpartum haemorrhage.

Below list of drugs are affected with this new safety update

SSRIs: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline

SNRIs: desvenlafaxine, milnacipran, venlafaxine

Vortioxetine

Performing Individual Benefit-Risk (BR) Analysis: Physicians who are prescribing these class of medicines should consider this risk in the context of an individual patient’s RISKS (bleeding and thrombotic risk assessment during the peripartum period) and the BENEFITS of antidepressants for the patient’s mental health during the period of treatment.

Underlying mechanism:

Serotonergic effect of SSRIs and SNRIs leads to impairment in platelet aggregation which causes bleeding abnormalities. Review of spontaneous data in the context of a wider literature review for SSRI and SNRI medicines identified observational studies reporting an increased risk of postpartum haemorrhage in association with antidepressant use in late pregnancy, particularly for SSRIs and SNRIs. This review concluded a slightly increased risk of postpartum bleeding with use of these class of medicines during the month before delivery.

The product information labels and patient leaflets for these medicines would be updated to reflect this new safety information of warning for the increased risk of postpartum haemorrhage.

Important information for healthcare professionals:

MHRA advised healthcare professionals with the below information for safe and effective use of SSRI and SNRI class of medicines in pregnant women.

  • Risk of postpartum haemorrhage: To be aware of this new safety update of increase in the bleeding risk with SSRIs and SNRIs use in pregnant women in the last month before delivery.
  • Consistent & Specific BR analysis: Continuous evaluation of benefits and risks for use of antidepressants during pregnancy in terms of individual pregnant women physical and mental health condition and the risks of untreated depression in pregnancy. Consider the individual patient risk factors for bleeding thrombotic adverse events.
  • Gathering more information on medical history and underlying medical conditions: Should enquire about the use of antidepressant medicines, particularly in women in the later stages of pregnancy.
  • Be aware of this risk and do not stop anticoagulant medication in women at high risk of thrombotic events in reaction to these data.
  • To be cautious, conscious, and accountable on monitoring the safety experience of medicines and report any suspected adverse drug reactions associated with medicines taken during pregnancy to the respective health authority.

Voluntary ADR reporting

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favourable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing safety data from the postmarketing 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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