azithromycin & statins combo = muscle damage risk

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warning: azithromycin & statins combo = muscle damage risk

Azithromycin is an antibiotic used to treat Mycoplasma pneumoniae and other mycoplasmal infections. Often both azithromycin and statins are given as long term treatment. New research shows that azithromycin in combination with statins can cause a 64% higher rate than expected of rhabdomyolysis, which is the rapid destruction of skeletal muscle detrimentally affecting movement of the skeleton at the joints. * * * * * * * * * * * * * * * * * * * * * * * * * * *Risks revealed of statins and azithromycin combinationBy Nigel Praities Pulse - London,UK - June 25, 2009<http://www.pulsetoday.co.uk/story.asp?sectioncode=23 & storycode=4123104 & c=2>Patients who take macrolide antibiotics alongside statins may be at risk of serious muscle damage, new research suggests.A large international study has found patients taking azithromycin and statins have a 64% higher rate of rhabdomyolysis than expected.The researchers – from the World Health Organization Centre for Drug Monitoring in Sweden – combed through 4 million case records from 86 countries and found 9,000 reports of rhabdomyolysis.They found 58 reports of rhabdomyolysis in those taking azithromycin and statins from 2000 to 2008, but calculated they would only have expected 35.This pattern continued for all commonly-used statins analysed, with 24 reports for atorvastatin compared with seven expected. Simvastatin had 20 reports, as opposed to the 8.7 expected.Macrolides have been cited as potential interacting agents with statins as they are cleared through the same metabolic pathway, CYP3A4, but this is the first significant evidence of a link with azithromycin.Study leader Dr Johanna Strandell, drug safety analyst at the Upsala Monitoring Centre in Sweden, said: `This is particularly important given the seriousness of rhabdomyolysis as an adverse reaction.'Dr John Pittard, a GP in Staines, Middlesex, and hospital practitioner in cardiology, said the `monstrous half-life' of azithromycin probably played a role in the interaction and GPs should be cautious about prescribing the drugs together.`This is something GPs won't know about at the moment – it is certainly not coming up on my system. It should be looked at. It is not the most inconvenient interaction and should be easy to get around.'A spokesperson from the MHRA said: `We are closely monitoring reports of this possible interaction, so any action can be taken as appropriate.'The study was published online by the British Journal of Clinical Pharmacology.2009 copyright Pulse, CMP Medica. All rights reserved. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * THE STUDYRhabdomyolysis a result of Azithromycin and statins: an unrecognized interactionhttp://www3.interscience.wiley.com/journal/122462710/abstractJohanna Strandell, MSc Pharm 1,2 Andrew Bate, PhD 1,3 Staffan Hägg, PhD 2 I Ralph Edwards, FRCP 1 1 The Uppsala Monitoring Centre, Uppsala, Sweden 2 Division of Clinical Pharmacology, Sahlgrenska University Hospital, Göteborg, Sweden 3 School of Information Systems, Brunel University Correspondence to Johanna StrandellThe Uppsala Monitoring CentreWHO Collaborating Centre for International Drug MonitoringBox 1051SE-751 40 Uppsala SwedenTel: +46 18 65 60 82Fax: +66 18 65 80 88E-mail: Johanna.Strandell (AT) who-umc (DOT) org

This is an Accepted Article that has been peer-reviewed and approved for publication in the British Journal of Clinical Pharmacology, but has yet to undergo copy-editing and proof correction. Please cite this article as an "Accepted Article"; doi: 10.1111/1365-2125.2009.03473.x Accepted for publication 11 May 2009DIGITAL OBJECT IDENTIFIER (DOI)10.1111/j.1365-2125.2009.03473.x About DOICopyright Journal compilation © 2009 Blackwell Publishing LtdWHAT IS ALREADY KNOWN ABOUT THIS SUBJECT. • Rhabdomyolysis is a serious but rare adverse effect of statins.• The mechanism of rhabdomyolysis with statins is poorly defined, but the occurrence is known to increase with dose/concentration.• Some macrolides are known to interact with statins; however azithromycin has not been described to interact with statins with the exception of two literature case reports.WHAT THIS STUDY ADDS: • A case series in WHO-ADR database were suggestive of a possible drug interaction between statins and azithromycin with rhabdomyolysis.• A disproportionality measure, Omega, was shown to identify previously not recognized suspected drug interactions within the WHO-ADR dataset.ABSTRACTIntroduction: In a systematic screening of the WHO-ADR database, VigiBase, in July 2008, a measure of association used to detect interactions (Omega), highlighted azithromycin with the individual statins: atorvastatin, lovastatin and simvastatin and rhabdomyolysis.AIM: To examine all reports including rhabdomyolysis-azithromycin and statins in VigiBase to assess if the data was suggestive of an interaction.METHODS: The individual case reports in VigiBase and the original files were reviewed. In order to investigate the reporting over time for rhabdomyolysis with azithromycin and statins to VigiBase, Omega values were generated retrospectively.RESULTS: The reporting over time showed that rhabdomyolysis under concomitant use of azithromycin and statins was reported more often than expected from 2000 and onwards in Vigibase. After exclusion of possible duplicates and follow-up reports, 53 cases from five countries remained. Rhabdomyolysis occurred shortly after initiation of azithromycin in 23% of the cases. In eleven patients an interaction had been suggested by the reporter. With the exception of one patient, the statin doses reported were within the recommended daily doses.CONCLUSIONS: Case reports in VigiBase are suggestive that interactions between azithromycin and statins resulting in rhabdomyolysis may occur. This analysis showed the potential of the newly developed disproportionality measure, Omega, which can help us to identify drug interactions in VigiBase in the future. The results also showed that reviewing spontaneous reports can add information to previously not established drug interactions.* * * * * * * * * * * * * * * * * * * * * * * * * *