Revised: 1 August 2014
Safety Information
Early Warning System - Monitoring Communication
Statins and a possible risk of acute kidney injury (without rhabdomyolysis)
1 November 2013
Medsafe has identified a possible signal of acute kidney injury (without rhabdomyolysis) with the use of high-dose statins following a review of published literature. Myopathy (manifesting as muscle pain, tenderness or weakness) or rhabdomyolysis is a well-known adverse effect of statin therapy, with acute kidney injury occurring secondary to these symptoms. Recent studies however have suggested that there is a risk of acute kidney injury occurring without prior or concurrent onset of myopathy or rhabdomyolysis.
The Centre for Adverse Reactions Monitoring (CARM) has received a total
of 38 reports which fulfil the criteria for acute kidney injury with statins.
Of these, 24 also report rhabdomyolysis or creatine kinase elevations, which
are suggestive of muscle problems. Statins have been placed on Medsafe's
medicines monitoring scheme ()
because we are seeking additional information on whether or not acute kidney
injury occurs in the absence of muscle injury.
Acute kidney injury is defined in different ways, from acute renal failure with tubular necrosis or unspecified, through to need for renal replacement therapy such as haemodialysis, peritoneal dialysis or kidney transplantation.
Products Affected
Statins are indicated for patients at high risk of coronary heart disease or with exising coronary heart disease and patients with hyperlipidaemia.
| Product name | Sponsor |
|---|---|
| Atorvastatin | |
| Lipitor | Pfizer |
| Zarator | Pfizer |
| Simvastatin | |
| Arrow-Simva | Actavis |
| Lipex | Merck, Sharp & Dohme |
| SimStatin | AFT Pharmaceuticals |
| Vytorin (with ezetimide) | Merck, Sharp & Dohme |
| Pravastatin | |
| Cholvastin | Douglas |
| Pravachol | Pharmacy Retailing |
| Rosuvastatin | |
| Crestor | AstraZeneca |
Additional Information
The overall benefit-risk balance of statins remains positive.
Advice on how to take this medicine and possible side effects can be found in the consumer medicine information (CMI) and data sheets for individual statins.
Regulator Actions
Medsafe is placing this safety concern on
to obtain further information. Please report any adverse events, in particular
suspected acute kidney injury with the use of statins.
Reporting
Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).
Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.
How to report an adverse reaction
Update to Original Communication
1 August 2014
The published studies that prompted the initial Medsafe review of statins
causing acute kidney injury through a direct effect rather than secondary
to rhabdomyolysis had limitations as well as innate confounding factors
that could not be adjusted for. Therefore, further information was sought
and this possible association was placed on the medicines monitoring ()
scheme.
During the monitoring period (1 November 2013 to 30 June 2014), a total of 48 adverse reaction reports for statins were received by the Centre for Adverse Reactions Monitoring (CARM). Of these reports, there was one report of acute renal failure and one report of renal failure aggravated; however both cases were secondary to rhabdomyolysis experienced by the patient.
Overall, data suggesting that statins cause acute kidney injury in the absence of myopathy or rhabdomyolysis is weak. The increased risk of acute kidney injury may be associated with the use of high-potency statins (measured by dose or LDL-lowering ability). It cannot be excluded that the patients receiving higher-potency statins were not already at risk for renal adverse events because of pre-existing risk factors (co-morbidities, concomitant medicines) that led to the prescribing choice.
The balance of benefits and risks of harm for statins remains positive and no further action is required at this time.
