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Statins: Updates to product safety information

3 November 2009

Statins are medicines widely used to treat people with high levels of cholesterol and triglycerides (fats) in their blood. Lowering the body's cholesterol levels reduces the risk of major cardiovascular events, such as heart attacks or strokes.

A Europe-wide review of clinical trial data, adverse drug reaction reports and published literature on statins has concluded that any of the following adverse reactions may be associated with statin use: sleep disturbances, memory loss, sexual dysfunction, depression and interstitial lung disease (leading to breathing problems). Product information for all statins will be updated with warnings on all of these side effects.

The following Public Assessment Report (published November 2009) presents a summary of the data and conclusions from the review.

Download the public assessment reportPDF file (opens in new window) (334Kb).

Read the November Drug Safety Update for further information.

Page last modified: 04 November 2009