warning: azithromycin & statins combo = muscle damage risk

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_warning: azithromycin & statins combo = muscle damage risk _

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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.

 

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Risks revealed of statins and azithromycin combination

By Nigel Praities

Pulse - London,UK - June 25, 2009

<_http://www.pulsetodhttp://wwhttp://wwwhttp://www.pht & storycode=storyco & c=c

_

(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.A

 

The study was published online by the British Journal of Clinical

Pharmacology.

 

2009 copyright Pulse, CMP Medica. All rights reserved.

 

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THE STUDY

 

Rhabdomyolysis a result of Azithromycin and statins: an unrecognized

interaction

_http://www3.http://www3.http://wwwhttp://www3.<WBRhttp://www_

(http://www3.interscience.wiley.com/journal/122462710/abstract)

Johanna 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 Strandell

The Uppsala Monitoring Centre

WHO Collaborating Centre for International Drug Monitoring

Box 1051

SE-751 40 Uppsala Sweden

Tel: +46 18 65 60 82

Fax: +66 18 65 80 88

E-mail: _Johanna.Strandell_

(Johanna.Strandell)

 

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-This is anThis is a

Accepted for publication 11 May 2009

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1365-10.1111/j.10.1111/j.1365-<W

Copyright Journal compilation © 2009 Blackwell Publishing Ltd

 

WHAT 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.

 

ABSTRACT

Introduction: 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-AIM: To examine all

reports including rhabdomyolysis-<WBR>azithromycin and statins in VigiBa

 

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.

 

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