The Pharmaceutical Journal
Vol 280 No 7488 p144
9 February 2008

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News summary

New statin side effects warning

Additional side effects have been identified for statins as a class, the Medicines and Healthcare products Regulatory Agency announced this week in the February 2008 issue of Drug Safety Update. The agency says that patients should be made aware that depression, sleep disturbances, memory loss and sexual dysfunction could occur.

However, the MHRA maintains that the benefits of statins are well established and outweigh the risk of side effects in most patients.

Statins may very rarely be associated with interstitial lung disease, the MHRA adds. Patients should see their doctor if they develop symptoms that could suggest this condition, such as dyspnoea, non-productive cough and general deterioration in health.

The bulletin also flags up a phased withdrawal of carisoprodol (Carisoma) from the UK market, following suspension of the product’s EU licences by the European Medicines Agency last year (PJ, 24 November 2007, p579).

Carisoprodol, the bulletin says, is associated with increased risk of abuse, addiction, intoxication and psychomotor impairment, and safer alternatives for the management of acute musculoskeletal disorders are available.

The agency is also considering a phased withdrawal of products containing meprobamate — which is the main active metabolite of carisoprodol — because “the conclusions of the recent European review of carisoprodol are pertinent to meprobamate”.