Yesterday we talked about Advair's potential generic adversaries. Now, the GlaxoSmithKline asthma drug--and its sister meds--have a new problem. The FDA is adding new warnings to their product labels intended to sharply limit their use.
The FDA's worry stems from analyses of clinical trials that showed an increased risk of hospitalization--and even death from worsening asthma symptoms--in patients using long-acting beta agonists. The class includes Novartis' Foradil and Glaxo's Serevent--which are single-agent LABAs--and Advair and AstraZeneca's Symbicort, which are combo meds that also contain inhaled steroid medication. The combo meds aren't as problematic as the single-agent drugs, FDA says; in fact, the agency is recommending against use of the single-agent LABAs at all unless they're combined with an inhaled steroid drug.
Safety concerns about LABAs have arisen a few times over the years, but this is the first time FDA has stood up to say "their use should be limited, whenever possible, due to an increased risk of asthma exacerbations, hospitalizations and death," as CDER pulmonary and allergy director Dr. Badrul Chowdhury says in a statement.
The FDA has several specific recommendations about LABA use, which you can check out at the agency's website (link below). Suffice it to say that the FDA's intervention here has investors and analysts worried, particularly on Glaxo's behalf, because the drugmaker takes in more than $7 billion annually from the asthma remedy.
GSK stock dropped on the news as analysts scratched their heads over the agency's move. The company itself says that there's no evidence from clinical trials or long-term patient use that Advair is linked with increased death or hospitalization, and that it will work with the FDA on wording for the product label. Meanwhile, the agency says the combo agents should be studied specifically to determine their safety risks. So stay tuned.