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Heart failure warning with dronedarone

By News team

Dronedarone (Multaq; Sanofi-aventis) is associated with an increased risk of heart failure, according to the Medicines and Healthcare products Regulatory Agency’s latest Drug Safety Update.

February’s DSU reports on a placebo-controlled trial of 627 heart failure patients, which found a higher risk of mortality among patients treated with the drug, which was launched last April for the treatment of atrial fibrillation. It has also been associated with an increased risk of new-onset or worsening heart failure, with 257 serious cases reported worldwide by 26 January 2011.

Because of these findings dronedarone is now contraindicated in haemodynamically unstable patients, including those who experience heart failure symptoms when at rest or with minimal exertion.

Patients should be advised to contact their doctor if they develop or experience worsening symptoms of heart failure, such as weight gain, dependent oedema or increased dyspnoea. Consideration should be given to suspending or discontinuing dronedarone therapy in such cases, the DSU advises.

It also highlights the drug’s association with liver injury, and reminds healthcare professionals of the need for measures such as regular liver function tests and to advise patients to contact a doctor if they develop symptoms of liver damage.

The latest DSU also advises on reports of rare but potentially serious cases of eosinophilic pneumonia with the use of daptomycin (Cubicin; Novartis). Common symptoms include cough, fever and dyspnoea, often occurring after two weeks of treatment. Treatment should be discontinued immediately if the condition is suspected, and the patient treated with corticosteroids if appropriate.

Healthcare professionals should also watch for signs of arterial and venous thromboembolic events in patients treated with lenalidomide (Revlimid; Celgene), and for thrombotic adverse reactions in patients treated with omalizumab (Xolair; Novartis).

Citation: The Pharmaceutical Journal URI: 11068593

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