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Safety Information

Revised: 1 August 2014

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo 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 (M² logo) 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 M² logo 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 (M² logo) 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.

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