FDA MedWatch Alert About LABA Asthma Drugs Follows Health Canada Warning In October 2005
On November 18, 2005 the FDA issued a MedWatch alert regarding Serevent, Advair, and Foradil to inform doctors and patients that the use of use of inhalation powders containing long-acting beta 2-adrenergic agonists ("LABA") may increase one's risk of severe asthma episodes and death.
The asthma inhalation powders addressed in the November FDA warning are:
- Serevent Diskus (salmeterol), made by GlaxoSmithKline;
- Advair Diskus (salmeterol combined with fluticasone propionate), made by GlaxoSmithKline; and,
- Foradil Aerolizer (formoterol), made by Novartis Pharmaceuticals Corp.
The FDA MedWatch alert advised patients receiving these asthma medications to seek medical attention immediately if their asthma worsens.
In early October 2004, Health Canada issued a similar safety alert regarding these three asthma medications, and a couple more. On October 4 Health Canada informed doctors and patients about the possible increased risks of asthma-related deaths associated with the use of asthma drugs known as long-acting beta-2 antagonists. In addition to Serevent, Advair, and Foradil, the Health Canada alert covered two additional asthma brand-name drugs:
- Oxeze (formoterol), made by AstraZeneca Pharmaceuticals LP; and,
- Symbicort (formoterol in addition to an inhaled corticosteroid), made by AstraZeneca, also.
The Health Canada alert included a reminder to doctors and patients about the recommended uses of long-acting beta-2 antagonists.
An article by Yael Waknine about the FDA MedWatch alert was published November 18, 2005 on the Medscape web site. In relevant part, this Medscape article provides information about the proper prescribing and use of the several medications in this LABA class of asthma drugs:
Healthcare professionals with asthma patients receiving these medications should be aware that LABAs are not intended as first-line therapy and should be reserved for use in those who have demonstrated an inadequate response to other asthma-controller medications such as inhaled corticosteroids.
Current guidelines from the National Heart, Lung, and Blood Institute and World Health Organization recommend inhaled corticosteroids as the first step in controller therapy, with LABAs as optional add-on therapy if low- to medium-dose inhaled corticosteroids provide inadequate relief.
A spokesman for GlaxoSmithKline ("Glaxo") told Reuters that the drug company disagreed with the FDA's proposed revised labeling for Serevent and Advair. According to a November 19, 2005 Reuters article, Glaxo maintains that "the revisions would be inconsistent with the standard of care for asthma treatment and could put many patients at risk of uncontrolled asthma."
In the same article, Reuters reported that a spokesman for Schering-Plough Corp., which markets Foradil in the U.S., said the drug company "is still discussing the proposed label changes with the FDA."
In July 2005 an FDA advisory panel convened to investigate the safety of Serevent, Advair, and Foradil concluded that these three asthma drugs were safe enough to stay on the U.S. market. This FDA advisory panel observed that Glaxo's Serevent and Advair already had a "black-box" warning on its package insert, or label, related to one study showing that Serevent patients had a higher, but relatively small, risk of life-threatening asthma attacks and deaths. This advisory panel recommended to the FDA that Novartis's asthma medicine Foradil -- given that it was part of the same LABA class of drugs -- should also carry a similar black-box warning.
Asthma is a chronic lung disease that afflicts about 15 million Americans, nearly 5 million of them children. Severe asthma attacks can be fatal.
(Posted by: Tom Lamb)