Less than a year after the FDA issued a warning about the long-term use of long-acting beta agonists, Saudi Arabian regulatory authorities have revoked marketing authorization for four such products - including GlaxoSmithKline's Serevent and Foradil, which is sold by Novartis - over increased risks of worsening asthma symptoms, hospitalizations of children and adults, and deaths.
In a statement, the SFDA says recent evidence found that LABAs were associated with increased risk of asthma-related deaths, intubation (the placement of a tube into the windpipe) and hospitalization of 2.8 percent for every 1,000 patients using a long-acting beta agonist compared to those who did not use such a medication. In analyzing data, the agency noted there were 16 deaths among LABA patients versus four among people were treated without the meds.
The move follows a health advisory issued last February by the US FDA, which determined the meds should never be used alone to treat asthma in children or adults, and also cited the increased likelihood of worsening asthma symptoms, hospitalizations and deaths. LABAs, by the way, are used to treat both asthma and chronic obstructive pulmonary disease (COPD) (see the this and this).
The Saudi restrictions do not apply to two other widely used LABAs - AstraZeneca's Symbicort and Glaxo's Advair - because these are combination meds that include inhaled corticosteroids. The Saudi agency banned Serevent and Foradil over concerns that there may be inappropriate use. Whether the US FDA sees fit to take similar steps remains to be seen.