Healthy Skepticism Library item: 3864

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Langreth R.
Asthma Drug Warning Strengthened
Forbes.com 2006 Mar 3
http://www.forbes.com/technology/sciences/2006/03/03/glaxosmithkline-advair-0303markets16.html

Keywords:
ADVAIR DISKUS Serevent salmeterol Seretide

Notes:

Ralph Faggotter’s Comments:

“ The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, that found a higher death rate in patients treated with salmeterol, one of the ingredients in Advair. “

If the study was done ‘several years ago’, it makes you wonder why it took so long to agree to the current restrictive warning label.

Full text:

Market Scan
Asthma Drug Warning Strengthened

A strict new warning may impact sales of one of the world’s top-selling asthma drugs.

GlaxoSmithKline (nyse: GSK – news – people ) said today it had reached an agreement to update its product label for its popular drug Advair with a strict new warning that advises doctors to limit the use of the drug only to patients who are not controlled on other asthma drugs, or have such severe cases.

The agreement comes in the wake of a giant 26,000 patient study, completed several years ago, 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 specific admonishments to 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,” the new label says. Advair contains two medicines, an inhaled steroid to control inflammation, and salmeterol, which improves symptoms by expanding the airways. There also is a new label for Glaxo’s Serevent, which just contains salmeterol.

GlaxoSmithKline “is pleased to have reached an agreement with [the] Food and Drug Administration on product labeling that is in the best interest of patients,” the company said in a statement.

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.

Exactly how the new label will impact sales of Advair is not clear. Since the FDA’s advisory last fall, Advair sales have continued to grow strongly. However, the new warning makes it official: doctors who use Advair as initial therapy in relatively mild cases would be using the drug off-label. Earlier this year, a GlaxoSmithKline executive insisted to analysts that any downside to a new label was limited since only 6% of Advair use is among patients not previously on asthma medication.