Re: Adverse effects of statins
Following your recent editorial about adverse effects of statins (1), we analysed the official information available in France for healthcare professionals and patients, about a relatively new adverse effect of this class: the diabetogenic effect.
The European Medicines Agency (EMA) acknowledged the diabetogenic effect of statins in March 2012. That date, the EMA demanded that summaries of product characteristics (SmPC) and package leaflets (PL) for all statins should be modified (2). A common text was written for the pharmaceutical firms and statins as a whole (3). The American Food and Drug Administration came to the same conclusions in February 2012 and transmitted the same request to US firms (4).
We therefore analysed the French SmPCs and PLs, all of them being on the website of the national medical products agency (Agence Nationale du Médicament et des produits de Santé, ANSM) (5).
During the 3 days following the ANSM database update on the 25th april 2014, we found 227 generic proprietary drugs and 34 brand name drugs containing a statin (6). SmPCs and PLs were not available online for 5 generic proprietary drugs and 1 brand name drug.
Of the 255 available SmPC, only 133 (52%) mentioned the diabetogenic effect of statins. With no exception, PLs were updated when and only when SmPCs were. Table 1 below show detailed results per statin.
More than 2 years after the EMA demand, nearly one SmPC/PL out of two had not been updated. The oldest molecules’data (pravastatin, simvastatin and fluvastatin) were the least updated.
SmPCs are crucial to healthcare professionals, as they form the basis of every other available information on drugs. PLs are also very important to patients’ information. However, despite the French law modifications following the benfluorex affair, official information on adverse effects of drugs is still unreliable (7).
In this context, we may find unsurprising that since 2012, no information at all has been sent from the ANSM to French healthcare professionals about the diabetogenic effect of statins, despite the fact that these drugs are prescribed to more than 6.4 million patients (8).
We feel that the French drug regulatory agency should take an urgent step to enforce its own decisions about health care professionals’ and patients’ information.
Dr Stambach Frédérick, GP at Haute-Vienne in France, firstname.lastname@example.org; competing interests: None
Dr Nicot Philippe, GP, expert for the Haute autorité de santé, and vice-president of the FORMINDEP association; competing interests: None
Dr Doubovetzky Jean, GP and senior writer for Prescrire journal, competing interests: None
1.Godlee F. Adverse effects of statins. BMJ 2014;348:g3306. Available at: http://www.bmj.com/content/348/bmj.g3306
2.EMA alert March 2012 - Pharmacovigilance Working Party (PhVWP) Monthly report December 2011 plenary meeting - WC500120115.pdf [Internet]. [quoted 9th Apr 2014]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/01/WC50...
3.Transparency Commission. HAS – Recommendations of the Transparency commission about the Crestor – put online on 15th April 2014 [Internet]. 2014. Available at: http://www.has-sante.fr/portail/upload/docs/evamed/CT-13465_CRESTOR_PIS_...
4.FDA. Drug Safety and Availability > FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs [Internet]. [quoted 20th March 2014]. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
5.ANSM. Index of proprietary pharmaceutical drugs [Internet]. [quoted 15th May 2014]. Available at: http://agence-prd.ansm.sante.fr/php/ecodex/index.php#result
6.Stambach F. The diabetogenic effect of statins, first reports and literature review [Internet] [Thèse d’exercice]. [France]: Faculté de médecine de Limoges; 2014. Available at: http://www.voixmedicales.fr/wp-content/uploads/2014/05/Th%C3%A8se-v5_5_1....
7.Law n° 2011-2012 of 29th December 2011 relating to the reinforcement of sanitary security of medicines and health products | Legifrance [Internet]. [quoted 26th Apr 2014]. Available at: http://www.legifrance.gouv.fr/affichTexte.do;jsessionid=?cidTexte=JORFTE...
8.Assurance Maladie. Usages des statines [Internet]. Point d’information; 2013. Available at: http://www.urml-oi.net/infos_temps_2013/Usage_statines_mai_2013.pdf
Competing interests: No competing interests