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US-Europe pioglitazone labelling differences clarified


Following recent reports that there is to be an additional boxed warning to the US label of Actos™ (pioglitazone) to increase awareness of risk of congestive heart failure, Takeda has clarified the difference in labelling between Europe and the USA.

In the USA, pioglitazone has only ever been contraindicated for heart failure – NYHA Class III–IV. This differs from the more stringent recommendations in Europe, where pioglitazone has been contraindicated for use in patients with heart failure, NYHA Class I–IV, since its launch in 2000. This is due to the fact that the pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.

When treating patients who have at least one risk factor for development of congestive heart failure (eg prior myocardial infarction or symptomatic coronary artery disease), physicians should start with the lowest available dose and increase the dose gradually. Patients should be observed for signs and symptoms of heart failure, weight gain or oedema, particularly those with reduced cardiac reserve.

National Electronic Library for Medicines 12/6/2007


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