LONDON, MAY 16:  The US Food and Drug Administration strengthened the warning labels for three asthma treatments, including GlaxoSmithKline Plc’s Advair and Serevent, six months after the tougher wording was proposed.
Novartis AG’s Foradil is also affected by the changes, which limit the drugs to people not helped by other medicines. The updated labels say the products “may increase the chance of severe asthma episodes, and death when these episodes occur,” the Washington, D.C.-based agency said on its web site.
Health regulators are getting stricter after health scares from products such as Merck & Co.’s Vioxx painkiller, which was pulled in 2004 because of links to heart attacks. Advair was Glaxo’s best-selling product last year, bringing in $5.6 billion, with Serevent adding another 300 million pounds. Foradil brought in $332 million last year, although only $14 million came from US sales.
The FDA first proposed the label change in November and London-based Glaxo said it would work with the regulator to “address the difference of opinion.”
A US advisory panel in July said that the medicines are safe and sales should be allowed to continue. The committee had been considering the safety of the medicines because of links to rare cases of worsened asthma.
The FDA restricted the drug’s use to patients who didn’t respond to other medicines. Long-acting bronchodilator medicines such as Advair and Foradil should only be used to treat asthma if other medicines, including corticosteroids, don’t work, the FDA said.
—Bloomberg