Review patients taking simvastatin 80 mg daily

NPS is encouraging prescribers to review patients currently taking simvastatin 80 mg daily, following changes to the prescribing information for the medicine issued by the TGA.  

The TGA recommendations were made in response to a US Food and Drug Administration (FDA) review of safety data, which found that people taking high dose simvastatin — 80 mg daily — had a greater risk of myopathy and rhabdomyolysis than people taking lower doses of the medicine.  

To reduce these risks, the TGA has recommended limiting use of simvastatin 80 mg daily and has issued new recommendations, contraindications and precautions for simvastatin.  

NPS has prepared information for prescribers to help them weigh up the risks and benefits for patients currently taking simvastatin 80 mg daily. The NPS web information also includes advice to give patients and a summary of the evidence behind the new safety information.  

NPS CEO Dr Lynn Weekes says that for patients currently taking simvastatin 80 mg daily, health professionals should weigh up the need for intensive cholesterol lowering against the risk of muscle injury, taking into account the individual’s circumstances.  

“Prescribers need to consider absolute cardiovascular risk as well as the LDL-cholesterol level when assessing a patient’s need for intensive cholesterol lowering,” says Dr Weekes.  

“Prescribers should also assess the individual’s risk of myopathy. It’s especially important to check for any interacting drugs. A number of drugs are now contraindicated with simvastatin because they increase the risk of muscle injury.”  

“If the risk of myopathy outweighs the benefit of taking simvastatin 80mg daily, prescribers should reduce their patient’s dose or switch them to a statin with a similar effect on LDL cholesterol.”  

NPS information for health professionals on simvastatin is available at  

Health professionals can advise patients that an updated consumer medicine information (CMI) leaflet for simvastatin (Zocor) is available on the TGA website. Patients with questions about simvastatin or any other medicines can also call the Medicines Line (1300 MEDICINE or 1300 633 424), Monday to Friday 9am to 5pm EST.


Independent, evidence-based and not-for-profit, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing.