Dapagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor which decreases glucose level by reducing glucose reabsorption and by increasing urinary glucose excretion.

Since 2012, this medicine has been indicated for the treatment of type 2 diabetes and also indicated for the treatment of below conditions in adults

  • Symptomatic chronic heart failure with reduced ejection fraction
  • Chronic kidney disease. 

AstraZeneca, the marketing authorization holder (MAH) of this medicine has withdrawn the indication for type 2 diabetes for commercial considerations due to a specific european-wide regulatory requirement for this authorization. [Not due to any safety concern].

Health care professionals and patients involved in the type 2 diabetes treatment with this Dapagliflozin are advised to be aware of this important information and consider alternative treatments by replacing this medication.

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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