Safety update:

Risk of venous thromboembolism with Dienogest: Product label update

Dienogest is an oral a progestogen used for contraception in the two below combinations-

  • Valette (dienogest/ethinylestradiol) is indicated for oral contraception and treatment of mild-moderate acne in women wanting contraception
  • Qlaira (dienogest/estradiol valerate) is indicated for oral contraception and treatment of heavy or prolonged menstrual bleeding in women wanting contraception (with no organic pathology).

Health Authority:

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

Important note for Healthcare professionals:

Awareness: To decipher this important safety information (risk of venous thromboembolism with Dienogest) to women and suggest for being cautious of its signs and symptoms which included the following-

  • Pain or swelling in the legs
  • Sudden unexplained breathlessness
  • Rapid breathing/cough
  • Chest pain.

Individual Benefit-risk ratio: The risk factor of venous thromboembolism with the use of Dienogest is 8 to 11 in 10,000 women for 1 year, which was identified by drug sponsor based on the results of meta-analysis conducted using four prospective cohort studies.

Though the overall benefit-risk profile for Dienogest remains favorable, prescribers are advised to be assess benefit-risk ratio based on individual patient, considering the following woman’s individual risk factors/contraindications:

  • Smoking
  • Obesity
  • Increasing age
  • Migraines
  • A family history of venous thromboembolism.

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

Before using Dienogest:

Be aware of this potential risk for Dienogest, and consider the above risk factors for venous thromboembolism before drug administration.

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.

After using Dienogest:

Be conscious of below signs and symptoms of venous thromboembolism and inform your respective healthcare professional or report to your national ADR reporting system.

  • Pain or swelling in the legs
  • Sudden unexplained breathlessness
  • Rapid breathing/cough
  • Chest pain.

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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