"http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON062553
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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 The review also considered published and unpublished data and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.