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We would like to bring to your attention some significant regulatory updates in the pharmaceutical industry that have emerged during the first quarter of 2024, sourced from the WHO Pharmaceuticals Newsletter No. 1, 2024. These updates highlight crucial information regarding potential risks associated with certain medications, as well as important safety measures recommended by regulatory authorities worldwide. Please review the following list of medicines along with the corresponding risk assessments and regulatory actions taken:

  1. Bupropion (South Africa): Updated to include the risk of Brugada syndrome.
  2. Cefazolin sodium hydrate and cefazolin sodium (Japan): Updated to include the risk of acute coronary syndrome accompanying allergic reaction.
  3. Dabigatran etexilate methanesulfonate (Japan): Updated to include the risk of oesophageal ulcer and oesophagitis.
  4. Dexibuprofen (oral) (Republic of Korea): Updated to include the risk of DRESS syndrome.
  5. Domperidone (Canada): Updated to include the potential risk of psychiatric withdrawal events when used for lactation stimulation.
  6. Finasteride (Japan): Updated to include the risk of suicide-related events.
  7. Nivolumab (Europe): Product information updated to include the risk of cytokine release syndrome.
  8. Olaparib (Europe): Product information updated to include the risk of hepatotoxicity.
  9. Peficitinib hydrobromide (Japan): Updated to include the risk of venous thromboembolism.
  10. Pembrolizumab and atezolizumab (Canada): Updated to include the potential risk of aplastic anaemia.
  11. Rivastigmine (Japan): Updated to include the risk of prolonged QT interval.
  12. Tofacitinib (Europe): Updated to include acne as an undesirable effect.
  13. Atorvastatin (Saudi Arabia): Safety signal issued regarding the risk of erectile dysfunction.
  14. Clomiphene citrate (France): DHPC issued for the risk of serious visual disturbance.
  15. Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Japan): Alerted for the risk of pemphigoid.
  16. Etoposide (Saudi Arabia): Safety signal issued for the risk of electrolyte imbalance.
  17. Hyoscine hydrobromide patches (United Kingdom): Anticholinergic side effects including hyperthermia highlighted.
  18. Ketamine (France): DHPC issued for the risk of severe liver and uro-nephrological damage.
  19. Levothyroxine (Saudi Arabia): Safety signal issued for the risk of vertigo.
  20. Medicines containing turmeric or curcumin (Australia): Risk of liver injury highlighted.
  21. Methotrexate (United Kingdom): Patients advised to take precautions against photosensitivity reactions.
  22. Pralsetinib (Europe): DHPC issued for the increased risk of tuberculosis.
  23. Progesterone (Saudi Arabia): Safety signal issued for the risk of meningioma.
  24. Sulphadoxine and pyrimethamine (Zimbabwe): Risk of toxic epidermal necrosis highlighted.
These regulatory updates underscore our commitment to ensuring the safety and well-being of our patients and healthcare professionals. It's crucial to stay informed about such developments to uphold the highest standards of patient care.