IMPORTANT MEDICINE SAFETY INFORMATION

Transcription

1 07 January 2018 IMPORTANT MEDICINE SAFETY INFORMATION Dear Healthcare Professional RE: SYSTEMIC AND INHALED QUINOLONE AND FLUOROQUINOLONE ANTIBIOTICS - RISK OF DISABLING AND POTENTIALLY LONG-LASTING SIDE EFFECTS AND THE INCREASED RISK OF AORTIC ANEURYSM AND DISSECTION In collaboration with the South African Health Products Regulatory Authority (SAHPRA), the companies listed below would like to inform you that the prescribing information of oral, parenteral and inhaled quinolones/fluoroquinolones are to be amended in view of new safety information that has become available. Patients may experience adverse reactions that may be disabling, long-lasting and potentially irreversible. The majority of these adverse reactions relate to the muscles, tendons, joints and nervous system including psychiatry disorders. As a consequence, the benefits and risks of all oral, parenteral and inhaled quinolone and fluoroquinolone antibiotics and their indications are being reviewed. Healthcare professionals are therefore advised that for the indications listed below, only to prescribe quinolone/fluoroquinolone antibiotics where other antimicrobials are considered not to be an appropriate treatment option, have failed, are contraindicated or not tolerated: for treating non-severe or self-limiting infections (such as pharyngitis, tonsillitis and acute bronchitis) for preventing travellers' diarrhoea or recurrent lower urinary tract infections for non-bacterial infections, e.g. non-bacterial (chronic) prostatitis and for mild to moderate infections (including uncomplicated cystitis, acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease (COPD), acute bacterial rhinosinusitis and acute otitis media). Caution is advised when prescribing for the elderly, patients with renal impairment, patients with solid organ transplants, and those concurrently treated with corticosteroids, as the risk of fluoroquinolone-induced tendinitis and tendon rupture may be exacerbated in these patients. Healthcare professionals should advise patients to stop treatment immediately at the first signs of a serious adverse reaction, such as tendinitis and tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects and to contact their doctor for further advice. There is some evidence of an association of quinolone/fluoroquinolone use and the risk of aortic aneurysm and dissection particularly in the elderly population. Therefore, in patients at risk for aortic DHCPL draft 3 to SAHPRA Quinolones/fluoroquinolones Group 2 Page 1

2 aneurysm and dissection, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic option. The conditions predisposing to aortic aneurysm and dissection include a family history of aneurysm disease, pre-existing aortic aneurysm or aortic dissection, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, and atherosclerosis. Patients should be advised about risk of aortic aneurysm and dissection and told to seek immediate medical attention in the emergency department in case of sudden severe abdominal, chest or back pain. Therefore, quinolones/ fluoroquinolones should only be prescribed to patients with a preexisting dilated aorta, aortic aneurysm or dissection, or the presence of other risk factors predisposing to aortic aneurysm/dissection, where other antimicrobials have been considered not to be an appropriate treatment option, have failed, are contraindicated or cannot be tolerated. Background to safety concern The European Medicines Agency (EMA) have reviewed systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the risk of serious and persistent (lasting months or years), disabling and potentially irreversible adverse reactions mainly affecting the musculoskeletal and nervous systems. Serious adverse reactions of the musculoskeletal system include tendinitis, tendon rupture, myalgia, muscle weakness, arthralgia and joint swelling. Serious peripheral and central nervous system effects include peripheral neuropathy, psychosis, anxiety, insomnia, depression, hallucinations, suicidal thoughts, confusion, as well as impairment of vision, hearing, smell and taste. Due to the seriousness of these reactions in previously healthy persons, any decision to prescribe quinolones and fluoroquinolones should be taken after a careful assessment of the benefits and risk and other appropriate treatment options that are available. The epidemiological studies [1-3] report an increase in risk of aortic aneurysm and dissection in patients taking systemic fluoroquinolones compared with patients taking no antibiotics or other antibiotics (amoxicillin); with older people being at higher risk. A non-clinical study [4] reported that ciprofloxacin increases the susceptibility to aortic dissection and rupture in a mouse model. This finding is likely to be a class effect similar to that of fluoroquinolones being harmful to tendon tissue. The product information for fluoroquinolones-containing medicines will be updated accordingly. For further information, please contact the respective companies indicated in the table below: Company Product Active ingredient Adcock Ingram Limited Adco 2 mg/ml Adco Winlomylon Suspension Registration Contact details Number A39/20.1.1/0646 Tel: Fax: adcock.aereports@adcock.com Nalidixic Acid A/18.5/26 Cipla Life Sciences (Pty) Ltd Ciploxx /20.1.1/0376 Tel: Fax: drugsafetysa@cipla.com Ciploxx /20.1.1/0377 Tel: Fax: DHCPL draft 3 to SAHPRA Quinolones/fluoroquinolones Group 2 Page 2

3 Company Product Active Registration Contact details ingredient Number Cipla Medpro Actor /20.1.1/0079 Actor /20.1.1/0080 Mofloxx 400 Moxifloxacin 44/20.1.1/1063 Norfloxacin Actor 400 Norfloxacin 34/20.1.1/0059 Octin Ofloxacin 36/15.1/0002 Tavaloxx /20.1.1/0007 Tavaloxx /20.1.1/0008 Tavaloxx /20.1.1/0009 Utin-400 Norfloxacin 31/20.1.1/0517 Dr. Reddy s Laboratories Cifloc /20.1.1/0308 Tel: Cifloc /20.1.1/0309 AdverseEvents.SA@drreddys.co m DRL Moxifloxacin 400 Moxifloxacin 42/20.1.1/0442 Mylan Ciprogen IV 200 mg/100 ml (Solution) Ciprogen 250 mg (Film-coated Xixia Pharmaceuticals [Marketed by Mylan ] Ciprogen 500 mg (Film-coated Mylan 250 mg (Film-coated Mylan 500 mg (Film-coated 2 mg/ml hydrochloride monohydrate 250 mg ciprofloxacin hydrochloride monohydrate 500 mg ciprofloxacin hemihydrate 256,23 mg 250 mg levofloxacin hemihydrate 512, mg levofloxacin A40/20.1.1/0618 Tel: / medinfosa@mylan.com 36/20.1.1/ /20.1.1/ /20.1.1/0841 Tel: / medinfosa@mylan.com 43/20.1.1/0842 DHCPL draft 3 to SAHPRA Quinolones/fluoroquinolones Group 2 Page 3

4 Company Product Active ingredient Actavis Pharma Artav 250 (film, a coated tablet) 250mg subsidiary of Teva 5 tablets Pharmaceuticals Artav 500 (film Industries coated tablet) 500mg [Marketed by Astral Health 5 tablets Care )] Artav 500 (film coated tablet) 10 tablets Artav 750 (film coated tablet) 500mg 750mg Registration Contact details Number 43/20.1.1/0370. Tel: Fax: Safety.South-Africa@teva.co.il 43/20.1.1/ /20.1.1/ /20.1.1/ tablets Ciprol 500, 10 tablets Ciprol 250, 10 tablets 500mg 250mg 37/20.1.1/ /20.1.1/0573 Healthcare professionals should report all suspected adverse effects associated with the use of all quinolones and fluoroquinolones containing medicines to the applicable company indicated above or to the NADEMC (National Drug Event Monitoring Centre) - Tel: or Fax: or SAHPRA Pharmacovigilance Office adr@health.gov.za Tel: /8197/8811/9696. Yours faithfully Thavendree Chetty Head: Compliance & Adcock Ingram Limited Dr Nic de Jongh Vice President - Chief Scientific Officer Cipla Medpro Erin Jenneker Cipla Life Sciences Herman Beyers Dr Reddy s Laboratories DHCPL draft 3 to SAHPRA Quinolones/fluoroquinolones Group 2 Page 4

5 Leanne Wentworth Mylan Mogini Nadasan Xixia Pharmaceuticals Laura Bartie Snr Manager Portfolio, BD & Regulatory Affairs/ Local Safety Officer Teva Pharmaceuticals Emily Ramalingham Actavis Pharma References [1] Daneman N, Lu H, Redelmeier DA. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ Open Nov 18; 5(11):e [2] Lee CC, Lee MT, Chen YS, Lee SH, Chen YS, Chen SC, Chang SC. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med Nov;175(11): [3] Pasternak B, lnghammar M and Svanstrom H. Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study. BMJ 2018; 360: k678. [4] LeMaire SA, Zhang L, Luo W, Ren P, Azares AR, Wang Y, Zhang C, Caselli JS, Shen YH. Effect of on Susceptibility to Aortic Dissection and Rupture in Mice. JAMA Surg Jul 25:e [Epub ahead of print] DHCPL draft 3 to SAHPRA Quinolones/fluoroquinolones Group 2 Page 5