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arznei-telegramm 2009; 40: 30

 


Nightmares on CSE inhibitors: A 61-year-old woman began to experience nightmares after several days' ingestion of pravastatin (PRAVASIN PROTECT, generics). Ten days after discontinuation of the hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor, she was asymptomatic again (NETZWERK report 12.240). The literature contains reports about nightmares on atorvastatin (SORTIS, generics) and on simvastatin (ZOCOR, generics; GREGOOR, P.J.H.S.: BMJ 2006; 332: 950; BORIANI, G. et al.: Ann. Pharmacother. 2001; 35: 1292). The German Federal Institute for Drugs and Medical Devices (BfArM) has documented ten reports of nightmares, one of abnormal dreams and 127 of sleep disorders not defined in more detail on statins (BfArM: letter of 27 Feb. 2009). Following 18 reports of nightmares on CSE inhibitors (and a further 9 reports of abnormal dreams), the Netherlands Pharmacovigilance Centre, Lareb, raised the possibility of a connection. In 11 patients (abnormal dreams: 5), an improvement was documented after discontinuation and in 5 (and 2 patients respectively) positive re-exposure. In patients on co-medication with beta-blockers, which can also be responsible for sleep disorders and nightmares, the beta-blockers were maintained long-term. Data from the WHO database (184 reports of nightmares and 134 reports of abnormal dreams on CSE inhibitors)* support the suspicion of a connection with statins. The authors recommend to add nightmares as an adverse reaction to the product information on all statins (Lareb: "HMG-CoA reductase inhibitors and nightmares or abnormal dreaming"; http://www.lareb.nl/documents/kwb_2008_3_statins.pdf).


 

*

These data do not include reports on lovastatin (MEVINACOR, generics), which is not marketed in the Netherlands.



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