Tags

Type your tag names separated by a space and hit enter

Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction.
Br J Clin Pharmacol. 2009 Sep; 68(3):427-34.BJ

Abstract

AIMS

In a systematic screening of the World Health Organization Adverse Drug Reaction 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. The aim was to examine all reports including rhabdomyolysis-azithromycin and statins in VigiBase to assess if the data were 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 cases. In 11 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 to identify drug interactions in VigiBase in the future. The results also showed that reviewing spontaneous reports can add information to drug interactions not established previously.

Authors+Show Affiliations

The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. johanna.strandell@who-umc.orgNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19740401

Citation

Strandell, Johanna, et al. "Rhabdomyolysis a Result of Azithromycin and Statins: an Unrecognized Interaction." British Journal of Clinical Pharmacology, vol. 68, no. 3, 2009, pp. 427-34.
Strandell J, Bate A, Hägg S, et al. Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction. Br J Clin Pharmacol. 2009;68(3):427-34.
Strandell, J., Bate, A., Hägg, S., & Edwards, I. R. (2009). Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction. British Journal of Clinical Pharmacology, 68(3), 427-34. https://doi.org/10.1111/j.1365-2125.2009.03473.x
Strandell J, et al. Rhabdomyolysis a Result of Azithromycin and Statins: an Unrecognized Interaction. Br J Clin Pharmacol. 2009;68(3):427-34. PubMed PMID: 19740401.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction. AU - Strandell,Johanna, AU - Bate,Andrew, AU - Hägg,Staffan, AU - Edwards,I Ralph, PY - 2009/9/11/entrez PY - 2009/9/11/pubmed PY - 2010/4/17/medline SP - 427 EP - 34 JF - British journal of clinical pharmacology JO - Br J Clin Pharmacol VL - 68 IS - 3 N2 - AIMS: In a systematic screening of the World Health Organization Adverse Drug Reaction 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. The aim was to examine all reports including rhabdomyolysis-azithromycin and statins in VigiBase to assess if the data were 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 cases. In 11 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 to identify drug interactions in VigiBase in the future. The results also showed that reviewing spontaneous reports can add information to drug interactions not established previously. SN - 1365-2125 UR - https://www.unboundmedicine.com/medline/citation/19740401/full_citation L2 - https://doi.org/10.1111/j.1365-2125.2009.03473.x DB - PRIME DP - Unbound Medicine ER -