Skip to content

Asthma Health Center

FDA Panel Asks: Are Asthma Drugs Safe?

Serevent, Symbicort, Foradil Safety Focus of Triple FDA Panel Meeting
Font Size
A
A
A
By
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 9, 2008 - Are the commonly prescribed asthma drugs Serevent, Symbicort, and Foradil safe?

That's the question facing a three-way meeting of the FDA's advisory panels on asthma, drug safety, and pediatrics.

Analysis of data pulled from clinical trials shows that patients taking Serevent, Symbicort, or Foradil have a small increased risk of asthma-related hospitalization. This is especially true for kids 4 to 11.

The same analysis shows that patients taking Serevent have a small but significantly increased risk of asthma-related death.

A fourth related drug, Advair, was not linked to these risks in the FDA analysis. Advair is a combination of an inhaled corticosteroid and the long-acting beta-agonist (LABA) Serevent. Symbicort is a combination of a different inhaled corticosteroid and a different LABA, Foradil.

Nobody is suggesting the drugs don't help a lot of children and adults with asthma. But do the drugs benefits outweigh their risks? The drugs already carry the FDA's top-level "black box" warning -- but are more warnings or restrictions needed? That's what the panel must decide in their two-day joint meeting, scheduled for Dec. 10-11.

Inhaled asthma drugs include:

  • Inhaled short-acting beta-agonists, often called rescue inhalers, which open the airways to fight the bronchial spasms that make it hard to breathe. These drugs are taken only as needed.
  • Inhaled corticosteroids, which fight lung inflammation. These drugs are taken every day for long-term asthma control.
  • Inhaled long-acting beta-agonists, LABAs, which open the airways to prevent bronchial spasms for long-term asthma control. These drugs are taken every day to prevent asthma attacks.
  • Intal and Tilade, which are another class of inhaled anti-inflammatory drugs. They are not steroids. Intal and Tilade are not under safety review.

When Serevent was first introduced, doctors didn't fully appreciate how important it was to fight inflammation as well as bronchial spasms. In early trials of the drug, fewer than half of patients took a corticosteroid along with Serevent.

In the early 1990s, a U.K. trial suggested there might be too many deaths among patients taking Serevent. This didn't stop the FDA from approving the drug -- but after a series of nagging adverse-event reports, Serevent maker GSK agreed to conduct a large safety study.

When Is Your Asthma Worse?

When Is Your Asthma Worse?

Take the WebMD Asthma assessment to get Personalized Action Plan

Start Now

Today on WebMD

Lung and bronchial tube graphic
5 common triggers.
group jogging in park
Should you avoid fitness activities?
 
asthma inhaler
Learn about your options.
man feeling faint
What’s the difference?
 
Madison Wisconsin Capitol
Slideshow
woman wearing cpap mask
Article
 
red wine pouring into glass
Slideshow
Woman holding inhaler
Quiz
 

Pollen counts, treatment tips, and more.

It's nothing to sneeze at.

Loading ...

Sending your email...

This feature is temporarily unavailable. Please try again later.

Thanks!

Now check your email account on your mobile phone to download your new app.

Man outdoors coughing
Article
Lung and bronchial tube graphic
Article
 
10 Worst Asthma Cities
Slideshow
runner
Article
 

WebMD Special Sections