As proposed by the US Food and Drug Administration (FDA), the UK-based pharmaceutical giant GlaxoSmithKline (GSK) is contemplating label changes for its asthma medications, like Advair, which contain LABAs, or long-acting beta-agonists.

GSK has stated that three FDA advisory committees that reviewed the available statistics pertaining to the asthma medications had “voted unanimously” that the “positive benefit-risk profile” of Advair has currently been labelled for adult patients.

According to the FDA’s Thursday proposal, the new wording on the asthma drug labels should necessarily state that the use of single-agent LABAs should be combined with an asthma controller medication; thereby indicating that LABAs should not be used alone.

Along with GSK’s Advair, the changes proposed by FDA will also affect GSK’s Serevent; Symbicort from AstraZeneca PLC; and Foradil manufactured by Novartis AG and marketed in the US by Merck & Co.

The FDA has given GSK, and the other affected manufacturers of LABAs-containing medicines, a one-month time period to comply with the proposed changes or else state a reason why the changes are unwarranted.