Statins: updated adverse reaction information in patient leaflets
- Medicines and Healthcare products Regulatory Agency
- 1 November 2009
- Therapeutic area:
- Cardiovascular disease and lipidology
Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
Article date: November 2009
New product information will shortly be coming into the packs of all statins (HMG-CoA reductase inhibitors: simvastatin, atorvastatin, pravastatin, fluvastatin, and rosuvastatin).
In February 2008, we reported a European-wide review on statins. New advice and information on side effects have been agreed, and healthcare professionals should be aware of the updated information so they can discuss it appropriately with new and existing patients.
The headline message from the review was that the balance of risks and benefits of statins as a class remains positive. Statins are one of the most important and widely used medicines in patients with lipid disorders and in the prevention of cardiovascular events. The efficacy and safety of statins have been studied in a number of large trials for both primary and secondary prevention of cardiovascular disease showing that overall, statins can reduce heart attacks and the need for bypass surgery and similar types of operation, and even save lives for certain patient groups. Trials have also shown that statins are generally well tolerated by most people who use them.
However, the review also identified the need for the product information for all statins to reflect the issues identified from analyses of clinical trial and postmarketing data from case reports of adverse drug reactions. These included sleep disturbance, memory loss, sexual disturbances, depression, and interstitial pneumopathy. The review also considered published and unpublished data and relevant clinical guidelines, and concluded that it was important that prescribers and patients alike are aware of the potential for these adverse reactions.
- Patients should be made aware that treatment with any statin may be associated with depression, sleep disturbances, memory loss and sexual dysfunction
- Statins may very rarely be associated with interstitial lung disease. Patients should seek help from their doctor if they develop presenting features of interstitial lung disease such as dyspnoea, non-productive cough, and deterioration in general health (eg, fatigue, weight loss, and fever)
On the basis of the data examined for individual statins and the class as a whole, the review concluded that there is sufficient evidence to support a possible causal relationship between statin use and the above adverse reactions. Summaries of Product Characteristics and Patient Information Leaflets are being amended to include the potential for these reactions.
Prescribers will wish to be aware of these changes coming through so that they can discuss them with patients.
Article citation: Drug Safety Update Nov 2009, vol 3 issue 4: 11.
Published: 1 November 2009
Therapeutic area: Cardiovascular disease and lipidology