Intended for healthcare professionals

Letters Adverse effects of statins

Information about diabetogenic effect of statins is inadequate in France

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4385 (Published 15 July 2014) Cite this as: BMJ 2014;349:g4385
  1. Frédérick Stambach, general practitioner1,
  2. Philippe Nicot, general practitioner, expert for the Haute Autorité de Santé, and vice president of the FORMINDEP Association2,
  3. Jean Doubovetzky, general practitioner and senior writer for Prescrire journal3
  1. 1Lieudit La Mareille, 87400 Moissannes, France
  2. 275 Avenue Léon Blum, 87350 Panazol, France
  3. 330 Rue Jules Amilhau, Résidence Chantilly, bâtiment B, appartement 65, 31100 Toulouse, France
  1. stambach.fred{at}orange.fr

We analysed the official information available in France for healthcare professionals and patients about the diabetogenic effect of statins after reading the editorial by Godlee.1

In March 2012, the European Medicines Agency (EMA) acknowledged the diabetogenic effect of statins and demanded that summaries of product characteristics and package leaflets for all statins be modified.2

We analysed French product summaries and package leaflets, which are all on the website of the national medical products agency (ANSM).

On 25 April 2014, we found 261 generic proprietary drugs or brand name drugs containing a statin.3 Product summaries and package leaflets were not available online for six of them.

Of the 255 available product summaries, only 133 (52%) mentioned the diabetogenic effect of statins. Without exception, package leaflets were updated only when product summaries were.

More than two years after the EMA’s demand, nearly half of French product summaries and package leaflets had not been updated. Data on the oldest drugs (pravastatin, simvastatin, and fluvastatin) were the least updated.

Product summaries are crucial to healthcare professionals because they form the basis of all other available information on drugs. Package leaflets are important for informing patients. However, despite modifications to French law after the benfluorex affair, official information on adverse effects of drugs is still unreliable.4

It is therefore not surprising that since 2012, the ANSM has sent no information to French healthcare professionals about the diabetogenic effect of statins, which are prescribed to more than 6.4 million patients in France.5

We think that the ANSM should take urgent steps to enforce decisions about information for healthcare professionals and patients.

Notes

Cite this as: BMJ 2014;348:g4385

Footnotes

References

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