The Pharmaceutical Journal Vol 267 No 7174 p701-706
17 November 2001

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Heart failure patients should not receive infliximab

Patients with rheumatoid arthritis or Crohn's disease should not start therapy with infliximab (Remicade) if they have congestive heart failure (CHF). In addition, patients with worsening CHF who are currently receiving infliximab should discontinue treatment. Discontinuation of infliximab should also be considered in patients with stable concomitant CHF, and such patients who continue therapy should have their cardiac status closely monitored.

This advice has been issued by the European Agency for the Evaluation of Medicinal Products, along with Centocor, the product licence holder for Remicade, and Schering Plough, the company marketing the drug in the United Kingdom.

The advice follows preliminary findings from a Phase II trial investigating the use of infliximab in patients with CHF. Higher rates of admission to hospital for worsening heart failure and deaths were seen in patients treated with infliximab. The companies report that at present, seven of the 101 patients treated with infliximab have died compared with none among the 49 patients given placebo.

A letter has been sent to doctors and pharmacists informing them of the new safety information for infliximab. Pharmacists should advise patients who are being treated with infliximab for Crohn's disease or active rheumatoid arthritis and who suffer from CHF that they should contact their doctor for advice.

Infliximab is a tumour necrosis factor inhibitor. It is licensed for use in patients with rheumatoid arthritis and Crohn's disease. It is not indicated for the treatment of congestive heart failure.

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