Glaxo and Novartis inhaler drugs labels updated to reflect risks

The FDA has announced that it has updated the labels for two GlaxoSmithKline asthma medicines and one Novartis product. The US governmental body said the changes were required to reflect the risk that Glaxo’s Advair and Seretide, as well as Novartis’ Foradil, could increase the chance of severe asthma attacks and possibly death.

All three products are long-acting beta 2-adrenergic antagonists (LABAs), which help to relax the muscles surrounding the lung’s airways.

The FDA statement said: “Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur.”

“In one asthma medicine study, an increased number of people taking a LABA in addition to their usual asthma care died from their asthma compared to people taking a placebo in addition to their usual asthma care, although the number of asthma deaths in the study was small.”

LABAs are normally used to prevent the incidence of asthma attacks, rather than in response to them, as is the case short-acting bronchodilatory drugs. The FDA says that LABAs should not be used if wheezing in patients is getting worse. It adds that LABAs should only be used if low or medium doses of corticosteroids fail to work.

LABAs are known as preventers as they reduce long-term inflammation in the lungs and they are often prescribed if patients need to use their reliever inhalers three times a week or more, according to the charity Asthma UK.

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