Fluoroquínolones for Systemic and Inhalation Formulations - Heart Valve Regurgitation, Cervical Artery Dissection, and Aortic Aneurysm and Dissection

To: All Health Facilities/All Health Care Practitioners in Dubai's Private Health Sector

Subject: Fluoroquínolones for Systemic and Inhalation Formulations - Heart Valve Regurgitation, Cervical Artery Dissection, and Aortic Aneurysm and Dissection

Dear colleagues,

Referring to the above subject, DHA notes all health facilities regarding the Circular issued by the MOHAP regarding the above subject manufactured by EMA

Reason for warning:

Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones) and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones.

Noted that the product is registered in the drug control of MOHAP​.

Therefore to:

Special warnings and precautions for use to be added in package leaflet in Fluoroquinclones for systemic & inhalation:

  • New data suggests that systemic and inhaled fiuoroquinaolones ma increase the risk of heart valve regurgitation/incompetence​.

  • In patients at risk for heart valve regurgitation/incompetence, systemic and inhaled fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options.