The CHMP Pharmacovigilance Working Party (PhVWP) has concluded that statins may cause sleep disturbances, memory loss, sexual dysfunction, depression and interstitial lung disease. Statins should be stopped if a patient develops interstitial lung disease.

The PhVWP conducted a review of statins (spontaneous reporting, clinical trials and the medical literature), triggered by spontaneously reported cases and information in the medical literature suggesting potential associations of statins with sleep disturbances, memory loss, sexual dysfunction, depression, interstitial lung disease and micturition disorders. 

The clinical trials provided evidence that for some statins the rates of sleep disturbances and memory loss were higher in the active than in the placebo group.  Spontaneous case reports included cases with a temporal relationship, positive dechallenge and positive rechallenge, providing further supportive evidence of a possible causal relationship of sleep disturbances (e.g. sleeplessness, nightmares) and memory loss with statins. The spontaneous case reports also showed that statins may be associated with sexual dysfunction, depression and interstitial lung disease.  The available evidence did not suggest that micturition disorders were associated with statins.

The PhVWP concluded its review with the recommendation to update and harmonise the product information for statins across the EU to include sleep disturbances, memory loss, sexual dysfunction, depression and interstitial lung disease as possible adverse reactions and to advise to stop treatment with statins, should a patient develop interstitial lung disease. The PhVWP recognised that the amount of evidence for the different adverse reactions varied among the statins but considered that there was no robust evidence to discriminate between the individual statins in terms of their risks.