Novartis, However, Continues To Disagree With FDA About The Need To Change Label On Foradil
GlaxoSmithKline has finally agreed with the FDA to revise a "black-box" warning on its asthma medications Advair and Serevent to further heighten awareness of an increased risk of death associated with salmeterol -- one of the active ingredients in Advair, and the active ingredient in Serevent
The revised versions of the "black-box" warnings on Advair and Serevent caution doctors and patients that salmeterol may increase the risk of asthma-related death. Black-box warnings are the most severe warnings that can be put on the label, or package insert, for prescription drugs.
Essentially, the revised black-box warnings provide this guidance for doctors as regards the prescribing of Advair and Serevent:
- Advair should be used only when other asthma drugs, such as low-dose to medium-dose inhaled corticosteroids, do not work or if a patient's asthma is severe enough to merit use of two medications.
- Serevent should only be used as an additional medication when the low-dose to medium-dose inhaled corticosteroids are not sufficient or, again, if the patient's asthma is serious enough to merit use of two drugs.
According to a statement issued by GlaxoSmithKline, the drug company "is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients." As pointed out in a March 3, 2006 article by Forbes magazine reporter Robert Langreth:
The agreement, however, appears to represent a partial victory for the FDA, which issued a public healthy advisory last November warning that use of the drug should be limited. At the time, GlaxoSmithKline said that it disagreed with the proposed label change.
As one may recall, in November 2005 the FDA had asked that the labels, or package inserts, be updated for Advair and Serevent, along with a third asthma drug, Foradil.
Meanwhile, Novartis, Foradil's manufacturer, reportedly remains in talks with the FDA about the need for revising the black-box warning on its asthma drug.
The revisions to the black-box warnings for Advair and Serevent were prompted by a 26,000 patient study that was completed several years ago which found a higher death rate in patients treated with salmeterol. The previous black-box warnings on these asthma medications made mention of this large-scale study and its death rate data. The new label that will be used by GlaxoSmithKline adds the guidance set forth above, namely to restrict use of Advair and Serevent to patients who really need it.
Advair, Serevent, and Foradil are categorized as "long acting beta agonists" (LABA) drugs. These asthma medications are intended to provide long-term control and prevention of asthma symptoms, such as wheezing and shortness of breath, by helping muscles around the airways in the lungs stay relaxed.
(Posted by: Tom Lamb)