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Translation of a-t 2021; 52: 15
 

SIDE EFFECTS

GYRASE INHIBITORS: RISK OF ANEURYSM NOT JUST FOR RISK GROUPS

According to several observational studies, gyrase inhibitors such as ciprofloxacin (CIPROBAY, generics) increase the risk of aortic aneurysms and dissections. As a result, broad restrictions on use were passed in late 2018. Since then, patients in Germany with risk factors such as hypertension, arteriosclerosis or a positive family history should only be treated with gyrase inhibitors following a careful assessment of the risks and benefits and a consideration of other treatment options (a-t 2019; 50: 16).

A retrospective observational study (1) published in early 2021, however, indicates that there is an increased risk for those without risk factors too. A large American database was used to include around 28 million patients aged between 18 and 64 who were prescribed gyrase inhibitors or other antibiotics generally used for similar indications between January 2005 and September 2017. Aneurysms or aortic dissections newly diagnosed within 90 days of prescription of gyrase inhibitors were more common than in the comparison group (7.5 vs. 4.6 per 10,000 prescriptions, adjusted Hazard Ratio [HR] 1.20; 95% confidence interval 1.17-1.24). The risk increased in particular for abdominal aortic aneurysms (HR 1.31) and for iliac (HR 1.60) and other abdominal aneurysms (HR 1.58), but did not increase for aortic dissections (HR 1.09) or thoracic or thoracoabdominal aneurysms of the aorta (HR 1.05 and 0.90). According to predefined subgroup analyses, 18 to 34-year-olds are not affected (HR 0.99), but both 35 to 49-year-olds and 50 to 64-year-olds are affected (HR 1.18 and 1.24) (1). There were no differences in other subgroups, among other things of gender and hypertension (1).

The new data are broadly in line with the relatively consistent previous observational studies (e.g. 2-4). As far as we can see, only two retrospective investigations (5, 6) published at the end of 2020 come to different conclusions. In September 2020, the Pharmacovigilance Committee of the European Medicines Agency (EMA) deemed the data sufficient to prove a causal link between gyrase inhibitors and aortic aneurysms and dissections (7).

Overall, the new data confirm the known risk signs. The risk of aneurysms could also be increased in all patients from the age of 35. We have been advising that gyrase inhibitors only be prescribed cautiously and that patients be informed of possible serious harmful effects, including cardiotoxicity, liver and tendon damage, for many years (e.g. a-t 1999; No. 11: 120; 2002; 33: 15; e a-t 12/2015), -Ed.

1NEWTON, E.R. et al.: JAMA Surg., publ. online on 6 Jan 2021; doi:10.1001/jamasurg.2020.6165 (10 pages)
2PASTERNAK, B. et al.: BMJ 2018; 360: k678 (8 pages)
3LEE, C.C. et al.: JAMA Intern. Med. 2015; 175: 1839-47
4DANEMAN, N. et al.: BMJ Open 2015; 5: e010077 (9 pages)
5DONG, Y.H. et al.: JAMA Intern. Med. 2020; 180: 1587-95
6GOPALAKRISHNAN, C. et al.: JAMA Intern. Med. 2020; 180: 1596-605
7EMA: PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC meeting; http://www.a-turl.de/?k=unsi

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