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30 November 2009
The MHRA has published a public assessment report which discusses a review of some of the adverse effects of statins. The review concluded that 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.
Action
The balance of risks and benefits of statins as a class remains positive. However, healthcare professionals should be aware of the updated safety information so they can discuss it with new and existing patients in conjunction with a discussion around likely benefits. The NPC patient decision aid on statins may help in these discussions.
What is the background to this?
A Europe-wide review of clinical trial data, adverse drug reaction reports and published literature on statins was conducted by the MHRA. It assessed the evidence available on sleep disturbances, memory loss, micturation disorders, sexual disturbances, depression and interstitial pneumopathy with atorvastatin, fluvastatin, lovastatin (not available in the UK), pravastatin, rosuvastatin and simvastatin. The review concluded that, apart from micturation disorders, there was sufficient evidence that these adverse effects were a class effect of statins. It recommended that the safety wording in Summaries of Product Characteristics and patient information leaflets should be updated accordingly.
The public assessment report presents a summary of the data and conclusions from the review. The November issue of Drug Safety Update highlights the key points for prescribers and advises that:
- 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 (e.g. fatigue, weight loss, and fever)
More information on statins can be found on the cardiovascular disease – lipids floor of NPC
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