Statins are used to treat high cholesterol.
As part of its regular monitoring of adverse reactions, the EU agencies are presently investigating the following types of adverse reactions:
- sleep disturbances
- memory loss
- sexual disturbances
- depression
- rare lung disease.
These adverse reactions have been reported by doctors and patients.
The Pharmacovigilance Working Party of the European Medicines Agency (EMEA) is in dialogue with the companies that market the medicine about adding the risk of the above-mentioned adverse reactions to the package leaflet and summary of product characteristics.
Recommendations by the Danish Medicines Agency
The Danish Medicines Agency advises doctors to be alert to the suspected risk of sleep disturbances, memory loss, sexual disturbances, depression and rare lung disease.
The Danish Medicines Agency advises patients not to stop treatment with statins and to contact their doctor if they are unsure about the treatment.
Furthermore, the Danish Medicines Agency urges doctors and patients to report any observed adverse reactions.
You can download the summaries of product characteristics in the factbox to the right (in Danish only).
For further information, please contact Chief Medical Officer Doris I. Stenver, tel. +45 4488 9247 or our Consumer Safety Division, tel. +45 4488 9757.
Danish Medicines Agency, 22 July 2008 (updated 24 July 2008).
