The review of 22 studies involving 8,032 patients looked at the risk of fatal and non-fatal serious adverse events for patients taking formoterol, compared with those given placebo or the short-acting beta-2 agonist salbutamol.

Formoterol is a long-acting beta-2 agonist, a class of medicines whose safety has been called into question previously.

Too few deaths occurred in the studies to assess any differences in the risk of fatal serious adverse events.

Non-fatal serious adverse events, however, were increased by 57 per cent in patients given formoterol compared with those on placebo. No significant increase in either fatal or non-fatal events was seen with salbutamol.

AstraZeneca, which manufactures Oxis and the combination product Symbicort, which contain formoterol, told GP that a recent review of 80,000 patients showed that formoterol-containing products reduced risk of serious adverse events.

The company believes this reflects real-life practice more accurately than the clinical trial data used in the Cochrane review.

It said it has sent the data to the Cochrane Collaboration.

Novartis, manufacturer of Foradil, which also contains formoterol, said that data from 10 million patient-years of exposure showed a positive benefit/risk ratio for formoterol. A spokesman said people should not stop taking medications unless advised to by a doctor.

tom.moberly@haymarket.com

Cochrane Library

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