GlaxoSmithKline will update the product label for Advair with a new warning that tells doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.
This follows a 26,000 patient study that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. The death data were already in the label in a black-box warning, but now the label also includes tells doctors to restrict use of the powerful combination asthma drug to patients who really need it.
"[S]almeterol] one of the active ingredients in ADVAIR DISKUS may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma controller medications…or whose disease severity clearly warrants initiation of treatments with two maintenance therapies," is on the label now.
There is also a new label for Serevent.
You can go to the FDA site or to the GSK site for more information, and you can read more on the web, including at Yahoo and Forbes.