Several FDA officials have warned that because side effects of Advair, Serevent, Foradil and Symbicort may increase the risk of death, an FDA advisory panel should recommend that approval to use the drugs for treatment of asthma should be withdrawn or severely limited.
These medications are known as long-acting beta agonists (LABAs), and they are commonly prescribed to help avoid the inflammation of airways in the lungs and prevent asthma attacks. While they have been found to keep airways open, use of the medications could potentially increase the severity of future attacks, especially among children.
A panel of independent advisors to the FDA is scheduled to meet this week to review safety data on the four asthma inhalers.
In advance of these meetings, two FDA officials have concluded that asthma patients of all ages should no longer use Advair, Symbicort, Serevent or Foradil due to the increased risk of death. A third FDA official has indicated that Advair and Symbicort could still be used by adults, but that none of the inhalers should be used by children 17-years-old or younger.
Asthma is a chronic disease which affects 20 million Americans, including 6.5 million children, causing symptoms like difficulty breathing, spasms and wheezing.
Unlike rescue inhalers, which contain the beta-agonist albuterol and have a limited duration, these long-acting beta agonists are designed to be taken daily to prevent asthma attacks.
Advair, which is the biggest seller out of the four asthma drugs, is manufactured by GlaxoSmithKline PLC and generates sales of nearly $7 billion annually. The inhaler combines a steroid with Serevent, which is also made by Glaxo and contains salmeterol as its active ingredient. Sales of Serevent alone were $538 million last year.
Foradil, which contains formoterol as its active ingredient, is manufactured by Novartis AG and marketed in the U.S. by Schering-Plough Corp. It is used in combination with an inhaled steroid is Symbicort, which was introduced by AstraZeneca last year. In the first 9 months of 2008, Symbicort generated sales of just over $200 million.
The drugs already contain “black box” warnings about an increased risk of hospitalizations and death from asthma attacks while on the drugs, which is the strongest warning that can be placed on a prescription medication.
The FDA advisory panel is scheduled to meet on December 10 and 11 to consider whether additional regulatory actions involving use of these inhaled drugs to treat asthma should be recommended.
Even if approval for treatment of asthma is withdrawn, a recall of Advair, Serevent, Fordail or Symbicort will not occur, as the drugs are also approved for use in treating individuals suffering from chronic obstructive pulmonary disease, who are usually elderly.