Dear healthcare professionals,

Sanofi informs you about the new risk of developing regurgitation / heart valve failure associated with the use of fluoroquinolones for systemic and inhalation use.

Summary

• New evidence suggests that systemic and inhaled fluoroquinolones may increase the risk of regurgitation / heart valve failure.
• In patients at risk of developing regurgitation / heart valve insufficiency, fluoroquinolones for systemic and inhalation use should be used only after a careful assessment of the benefit / risk ratio and consideration of other possible therapy options.
• Conditions that predispose to the development of regurgitation / insufficiency of the heart valves include congenital or existing heart valve disease, connective tissue abnormalities (for example, Marfan syndrome or Ehlers-Danlos syndrome), Turner syndrome, Behcet's disease, hypertension, rheumatoid arthritis, and infective endocarditis.
• Patients should be informed about the risk of regurgitation / heart valve failure associated with the use of fluoroquinolones. Patients should be advised to seek immediate medical attention if shortness of breath or rapid heartbeat occurs, or swelling of the abdomen or lower extremities develops.

General safety information

Fluoroquinolones are antibiotics approved for the treatment of certain bacterial infections, including life-threatening ones. In the Direct Appeal to Healthcare Professionals dated 02/11/2019. reported the risk of disabling and potentially irreversible serious adverse reactions and the risk of developing aortic aneurysm and dissection of the aortic wall. The use of fluoroquinolones is limited to severe infections or infections where it has been decided that it is inappropriate to use other antibiotics that are usually recommended for these infections. Fluoroquinolones should be prescribed only after careful assessment of the benefit-risk ratio.

A recent epidemiological study [1] indicates an approximately 2-fold increase in the risk of developing mitral and aortic regurgitation in patients taking systemic fluoroquinolones compared with patients taking other antibiotics (amoxicillin or azithromycin).

There have been reports of several medically confirmed cases of regurgitation / insufficiency of any of the heart valves with at least a possible causal relationship in patients taking fluoroquinolones.
In addition, according to a laboratory study [2], exposure to ciprofloxacin led to the degradation of collagen in aortic myofibrolast cells transplanted from patients with aortopathy, including aortic regurgitation. These data provide insight into how the degradation of connective tissue associated with the use of fluoroquinolones may be associated with the development of regurgitation / heart valve insufficiency. Collagen degradation has also been identified as a cause of tendon and aortic abnormalities associated with fluoroquinolones.

Health care professionals have been advised to carefully assess the benefit / risk ratio of fluoroquinolones and consider other therapeutic options in patients with risk factors or conditions predisposing to the development of regurgitation / valvular insufficiency (such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Behcet's disease, hypertension, rheumatoid arthritis and infective endocarditis). In addition, we remind you of the recommendation to carefully evaluate the need for the use of fluoroquinolones in patients with risk factors or conditions predisposing to the development of an aneurysm or dissection of the aortic wall.

Patients should be advised to seek immediate medical attention if they experience acute shortness of breath or heart palpitations, or swelling of the abdomen or lower extremities.
The PID for fluoroquinolone-containing medicinal products will be updated accordingly.

Reporting adverse reactions

Health care professionals should report suspected adverse reactions in patients to the Pharmacological Committee at farmkomitet@minzdrav.uz or at: 100002, Tashkent, st. Ozod, K. Umarov's passage, 16.

Or to Sanofi at Uzbekistan.Pharmacovigilance@sanofi.com.

If you have any additional questions on the medical use of Plaquenil, you can contact Sanofi's medical information service at +998 90-990-87-48, or leave a message by filling out the feedback form on our website https://www.sanofi.uz/ru/contact

Sincerely,

Sanofi-Aventis Group JSC, French Republic, in the Republic of Uzbekistan
Address: st. Oybeka, 24, office block 3D, 100015 Tashkent
Tel .: + 998 (78) 147.03.44 / 45 - Fax: + 998 (78) 147.03.47
www.sanofi.uz

Ссылки

[1]    Etminan M, Sodhi M, Ganjizadeh-Zavareh S, Carleton B, Kezouh A, Brophy JM. Oral Fluoroquinolones and Risk of Mitral and Aortic Regurgitation. J Am Coll Cardial. 2019 Sep 17;74(11):1444-1450.
[2]    Guzzardi DG, Teng G, Kang S, Geeraert PJ, Pattar SS, Svystonyuk DA, Belke DO, Fedak PWM. Induction of human aortic myofibroblast-mediated extracellular matrix dysregulation: A potential mechanism of fluoroquinolone-associated aortopathy. J Thorac Cardiovasc Surg. 2019 Jan;157(1):109-119.