FDA calls for new warnings on asthma drugs
The warnings would apply to GlaxoSmithKline's Serevent and Advair and Novartis' Foradil, which is marketed in the U.S. by Schering-Plough.
An FDA spokeswoman said in a Wall Street Journal report that the agency wants to issue a black-box warning to Foradil since it is in the same class as Serevent and Advair, which already carry the warning.
The FDA said other drugs should be used first to control asthma and that Serevent, Advair or Foradil should only be used if other therapies fail.
In a statement, GlaxoSmithKline said it disagreed with the FDA's decision stating that treatment guidelines call for patients with moderate to severe asthma to be treated both with short-and long-acting asthma drugs.
"GSK believes sufficient safety information about these medicines is already in the labels to help guide physicians about their appropriate use," the company said.
Novartis did not comment on labeling changes over Foradil. Schering-Plough told The Journal through a spokeswoman that the company would send out a letter to healthcare professionals describing any changes once the new label is finalized.