A popular group of drugs used to lower cholesterol has been linked to sleep disturbances, memory loss, sexual dysfunction, depression and interstitial lung disease.
In its monthly report released yesterday, the European Medicines Agency's Pharmacovigilance Working Party (PhVWP) linked the statin group of drugs to the side effects after analysing data from spontaneous reporting, clinical trials and medical literature.
"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," the report said.
"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 agency warned that statins should be stopped if a patient developed interstitial lung disease.