Safety update:

Potential Risk of leaking heart valves (heart valve regurgitation) associated with the use of antibiotics belonging to the Fluoroquinolone class which included ciprofloxacin-, levofloxacin-, moxifloxacin- and norfloxacin-containing medicinal products which are administered by injection or by mouth (systemic) and by breathing in (inhaled).

Fluoroquinolones broader spectrum antibiotics which are used in the treatment of wide range of bacterial infections, including urinary and respiratory tract infections.

Health Authority:

Health Canada – Health authority of Canada.

Important note for Healthcare professionals:

To be cautious of the potential risk of heart valve regurgitation with fluoroquinolone antibiotics and assess the suitability/requirement of use of these class of antibiotics based on benefit-risk analysis considering individual patient’s medical conditions, concurrent medical conditions and below risk factors-

Risk factors for increased risk of heart valve regurgitation/incompetence with the use of fluoroquinolone antibiotics:

• Congenital or pre-existing heart valve disease
• Connective tissue disorders – Marfan syndrome or Ehlers-Danlos syndrome,
• Turner syndrome
• Bechet’s disease
• Hypertension
• Rheumatoid arthritis
• Infective endocarditis.

A Direct Health Care Professional Letter (DHCP) was issued in November 2020 pertaining to this safety information communication.

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

Be aware of this potential risk for fluoroquinolone antibiotics and consider informing your respective doctor or healthcare professional about your underlying medical conditions and concurrent use of other medications, even if they haven’t asked about the same.

Consider the above risk factors before starting treatment with fluoroquinolone antibiotics and discuss with your health care professional for better alternative treatment.

This facilitates the individual 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, thereby contributing to safe & effective usage of medicines.

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.