Renewed warnings to heart patients on anti-diabetes drug rosiglitazone

[25 January 2008 - 18h41]
[mis à jour le 28 January 2008 à 09h41]

The European Medicines Agency (EMEA) and the French Health Products Safety Agency (the AFSSaPS) are introducing new recommendations on the use of rosiglitazone, an anti-diabetes drug marketed in France under the names Avandia® and Avandamet®.

Today, the AFSSaPS “is recommending that patients being treated with rosiglitazone and who are suffering from a cardiovascular condition should contact their doctor in due course with a view to the possible modification of their anti-diabetes treatment”. This decision comes as no surprise. It is the result of a re-evaluation of the glitazone class undertaken over a year ago by the two health agencies.

This process was continued in January 2008. It is now recommended that this drug should not be prescribed to patients suffering from “ischaemic heart disease (ie caused by reduction or interruption of blood flow, as in myocardial infarction – editor’s note) or from peripheral arterial disease (reduced circulation in the legs or neck, as in arteritis – editor’s note)”. Another contra-indication has also been added in the case of “acute coronary syndrome (myocardial infarction or worsening angina attack)”. As this usually refers to patients who are already hospitalised, this recommendation can be seen more as a matter of form.

These decisions complement the statements issued by the AFSSaPS last October regarding two glitazones available in France: rosiglitazone but also pioglitazone (Actos® and Competact®). They in fact embody rules of use that have already been recognised. It should also be remembered that the AFSSaPS recommends that patients with cardiovascular disease should contact their doctor “in due course”.

Source : EMEA, 24 January 2008 ; AFSSaPS, 25 January 2008

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