The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.
The review is at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database and the published literature. There has been no previous European Union (EU) wide review specifically focusing on the persistence of the side effects, but the side effects themselves are known and covered in the EU prescribing information for these medicines.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used.
Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information
Please refer to the following websites in EMA for details:
http://www.ema.europa.eu/../human_referral_prac_000065.jsp&mid=WC0b01ac05805c516f
In Hong Kong, there are 199 registered pharmaceutical products for systemic administration containing quinolones and fluoroquinolones, including 84 ciprofloxacin, 60 levofloxacin, 37 ofloxacin, 5 moxifloxacin, 8 norfloxacin, 1 lomefloxacin, 1 prulifloxacin, 1 sparfloxacin, 1 nalidixic acid and 1 pipemidic acid products. All these products are prescription only medicines. There is no registered pharmaceutical product in Hong Kong for inhaled quinolone and fluoroquinolone.
Related news was previously issued by the US FDA and Health Canada, and the news associated with peripheral neuropathy was posted on the Drug Office website on 16 August 2013, the news associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system was posted on 13 May 2016, 27 July 2016 and 24 January 2017. Letters to inform local healthcare professionals were issued on 16 August 2013 and 13 May 2016. In December 2013, the Registration Committee of the Pharmacy and Poisons Board (the Registration Committee) discussed the matters on peripheral neuropathy with fluoroquinolones, and decided that the relevant warnings should be included in the sales packs and/or package inserts of the products. In September 2016, the Registration Committee further discussed the matters on disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system with fluoroquinolones, and decided to remain vigilant on any updates by other overseas drug regulatory authorities.
So far, the Department of Health (DH) has received two cases of adverse drug reaction (ADR) with levofloxacin, which were not related to the adverse effects mentioned in the above EMA’s announcement, and no ADR report has been received for the remaining fluoroquinolones. In view of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used, the DH will keep vigilant on the result and recommendation from EMA after review, and consider any action deemed necessary.
Ends/ Saturday, February 11, 2017
Issued at HKT 12:00
|
