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Asthma Drug Linked to Serious Adverse Events

Oct 17, 2008 | Parker Waichman Alonso LLP

The asthma drug formoterol, sold under the brand names Foradil (Novartis), Oxis (AstraZeneca), Atock (Astellas) and Perforomist, has been linked to an increased risk of non-fatal, serious adverse events, according to a new study.  The study,  conducted by  Cochrane Researchers, found that people who took the drug daily for at least 12 weeks showed a significantly increased risk than those who took a placebo.

Formoterol is a long-acting beta2-agonist which is inhaled to help open the airways and last for 12 hours or more.  Drugs like formoterol are used as "symptom controllers" to supplement preventive  corticosteroid asthma therapy.

For their formoterol study, the Cochrane Researchers reviewed 22 studies involving 8,032 people diagnosed with asthma.  In those studies that compared formoterol to a placebo, 16 patients per thousand taking formoterol suffered serious adverse effects, compared with only 10 per thousand  in the group taking placebos.  That translates to a 57 percent  increase in non-fatal serious adverse events compared with placebo, the researchers said.  

 Serious adverse effects were most commonly asthma–related. The increase in adverse events was more marked in younger patients.  

'It is possible that children are at a higher risk of suffering serious effects due to this drug, but we can't say for sure," Christopher Cates, B.M.B.Ch., of St. George's University of London, one of the authors of the study, said.  "We would urge that all serious adverse events are more fully reported in medical journals so that we can make a better assessment of drug safety."

Three deaths occurred in patients taking formoterol compared with none in placebo patients, although the difference did not reach statistical significance.

"It was not possible to assess disease-specific mortality in view of the small number of deaths," the researchers said.

The same researchers released another study  this past summer which found that the long-acting beta2-agonist, Serevent, also increased the likelihood of serious adverse events, including death.  In a review of 26 double-blind randomized controlled trials, 45 of every 1,000 patients treated with Serevent had a serious adverse event, compared with 40 taking placebo.

Using data from two large surveillance studies, the researchers also found that regular Serevent use increased the risk of asthma-related mortality in patients who did not also use inhaled steroids.  Also, the mortality from any cause was higher with Serevent than with placebo.