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2 March 2012

Statins are a class of prescription medicines used together with diet and exercise to reduce cholesterol levels (and to prevent cardiovascular events such as heart attacks and strokes). Statins are available as single medicines and combination products and include:

  • Atorvastatin (e.g. Lipitor)
  • Fluvastatin (e.g. Lescol)
  • Pravastatin (e.g. Pravachol)
  • Rosuvastatin (e.g. Crestor)
  • Simvastatin (e.g. Zocor)

On 28 February and 1 March 2012 the US Food and Drug Administration (US FDA) announced changes to the safety label information that will be published for statins.

In Australia, this type of information about a medicine is normally placed in the Product Information (PI) document. The TGA is currently reviewing the evidence for these safety-related changes to label information made by the FDA and will update the Product Information for these medicines where necessary.

Patients taking statins should not stop taking their medication without expert advice from their treating clinician, and if they have questions or concerns they should speak to their doctor or other appropriate health professional.

Information about the US safety-related information

Memory loss

The FDA is including information about some patients experiencing memory loss and cognitive impairment that is reversed when the patients stop taking the statin.

Increased blood sugar levels

The FDA is warning of a potential risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus.

Liver monitoring

The FDA is removing the recommendation for routine periodic monitoring of liver enzymes in patients taking statins.

Lovastatin interactions

Changes have been made to the lovastatin label regarding interactions with other drugs.

Muscle injury associated with interactions with HIV and Hepatitis C drugs

The FDA has made changes to statin labels regarding interactions with protease inhibitors (medicines used to treat HIV or hepatitis C virus infection). These interactions may lead to an increased risk of muscle injury.

In Australia

  • Memory loss and related terms are already included in the Product Information for some statins, but cognitive impairment and confusion are not generally mentioned. The TGA will assess whether the Product Information for any or all of these medicines requires updating to reflect current understanding of these issues.
  • The TGA has commenced a review of the association between diabetes, increased blood sugar levels and statin use (some of the causes of high cholesterol levels can also result in type 2 diabetes).
  • Currently, recommendations regarding testing of liver function vary across different statin products. Periodic monitoring is recommended for most but not all statins. The TGA will assess whether recommendations for periodic monitoring should change.
  • Lovastatin is not available in Australia.
  • The TGA will review the evidence associated with the use of statins and protease inhibitors. Muscle injury has a well-recognised potential to occur with statin use.

Reporting adverse events

Consumers and healthcare professionals are encouraged to report adverse events suspected of being associated with statins to the TGA. Your report will contribute to the TGA's monitoring of the safety of these medicines.

However, the TGA cannot give personal advice about an individual's medical condition, as any such advice needs to take into account an individual's particular circumstances. Consumers are strongly encouraged to talk with a health professional if they are concerned about a possible adverse reaction to any medicine.