Br J Clin Pharmacol. 2016 Apr 13. doi: 10.1111/bcp.12973. [Epub ahead of print]
Ekhart C1, de Jong LA1, Gross-Martirosyan LD2, van Hunsel FP1.
Author information
- 1Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, The Netherlands.
- 2Dutch Medicines Evaluation Board Agency, Utrecht, The Netherlands.
Abstract
AIM:
Statins are used in the treatment of hyperlipidaemia. They are among the most commonly prescribed drugs worldwide. Statins have been linked to musculoskeletal adverse drug reactions, however muscle rupture has not been discussed as an adverse drug reaction to statins so far. The aim of this article is to give an overview of cases of muscle rupture associated with the use of statins.
METHOD:
We analysed the cases of muscle rupture associated with the use of statins that were collected by the Netherlands pharmacovigilance centre Lareb complemented with the review of cases from the EudraVigilance database.
RESULTS:
Fifteen cases of muscle rupture associated with statin use have been identified in the database of the Netherlands pharmacovigilance centre; overall, there was a plausible temporal association of events in most cases. In addition, the EudraVigilance database contained 165 reports of muscle rupture reported in patients using statins. Muscle rupture was disproportionally associated with statin use in both databases. The reporting odds ratio was 23.4 (95% CI 11.9-46.0) and 14.6 (95% CI 12.3-17.2) respectively.
CONCLUSION:
Data from spontaneous reporting systems suggest that use of statins is associated with muscle rupture. Physicians and patients should be aware that this can occur. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.