FDA investigating asthma medications

December 17, 2008
Alaina Scott, Senior Editor

The U.S Food and Drug Administration is investigating whether some asthma medications, in rare cases, can increase the risk of serious asthma complications.

The U.S Food and Drug Administration is investigating whether some asthma medications, in rare cases, can increase the risk of serious asthma complications. Independent medical advisers recently heard three days of scientific evidence and recommendations on whether the drugs should continue to be used to treat asthma.

The testimony led to the decision that Advair and AstraZeneca Plc’s Symbicort were safe enough for treating asthma, but two less frequently used medicines are too risky. Evidence of asthma-related deaths and serious complications led the panel of experts to warn against continued use of Glaxo’s Serevent and Novartis AG’s Foradil for adults, adolescents, and children with asthma.

All of the inhaled drugs contain long-acting beta agonists, but Advair and Symbicort add a steroid, which the panel said made the medicines less risky. “It looks like use of LABAs alone is more dangerous,” said consumer advocate Sidney Wolfe, director of Public Citizen’s Health Research Group. The FDA is now considering the recommendations as officials decide whether the drugs should continue to be approved for treating asthma. Advair is currently indicated for the treatment of asthma and COPD and is available in three formulations - 100/50, 250/50, and 500/50. Each strength contains 50 mcg of salmeterol, a bronchodilator of the beta-2 agonist type, but differing amounts of fluticasone propionate, an anti-inflammatory corticosteroid.

Patients should not stop taking any of their asthma medications without consulting a doctor, John Jenkins, head of the FDA’s Office of New Drugs, advised after the meeting. Advair is Glaxo’s best-selling drug, with $5.6 billion in worldwide sales through the first nine months of the year. Symbicort’s sales for the same period were $1.5 billion, according to the company. Serevent sales were at $376 million.

Schering-Plough Corp, which markets Foradil in the United States, reported sales of $76 million for that drug. Drug-safety reviewers urged limits, including withdrawing the asthma approval for all of the medicines in children. Experts in another FDA division that reviews asthma drugs said the numbers of deaths and serious complications were small and risks were manageable with appropriate warnings.

Doctors on the FDA panel said the drugs offered important benefits for their patients. An FDA analysis found 2.8 more serious asthma-related complications, including deaths and hospitalizations, for every 1,000 patients treated with a LABA.

The panel unanimously backed the use of Advair by adults and voted 23 to 3, with one abstention, for its use by adolescents. More concern surrounded use by children, with panelists complaining there was little data to guide them. They voted 13 to 11 with three abstentions that Advair was safe enough for children age 4 to 11.

The FDA could decide to revoke the approval of Serevent and Foradil for asthma, although the drugs would continue to be sold for treating another lung disease, chronic obstructive pulmonary disease.