FDA Panel to Scrutinize Safety of Some Asthma Treatments

December 08, 2008 03:59 PM
by Emily Coakley
The nation’s drug regulator is asking its advisers to consider the safety of some drugs used to treat asthma in children and adults.

Drugs Linked to Asthma-Related Death

A Food and Drug Administration panel is going to hold hearings this week to review the safety of a particular group of asthma medications after the agency’s staff recommended the drugs be prohibited for kids 18 and younger, Reuters reported.

The drugs in question are known as long-acting beta agonists (LABAs), and there are concerns that they are linked to “asthma-related deaths and asthma attacks,” the news service said.

The medications that could be affected are Foradil, which is made by Novartis AG and marketed in the United States by Schering-Plough Corp.; Advair and Serevent, which are both made by GlaxoSmithKline; and Symbicort, which is made by AstraZeneca.

Serevent and Foradil shouldn’t be used by people of any age with asthma, FDA staff has said.

According to the Philadelphia Inquirer, who cited FDA documents, kids ages four to 11 taking LABAs “appeared to be at greatest risk for complications than those taking older treatments.”

Long-acting beta agonists are inhaled along with steroids. LABAs keep constricted airways open for at least 12 hours, according to the Mayo Clinic, and reduce the use of what are known as “rescue medications” that quickly open up airways. LABAs are useful at night, and people who took them reported waking up less, and having a better quality of life than those who only took steroids for asthma, the clinic said.

Opinion & Analysis: Prohibition predictions; what to do if you’re taking a LABA

On Shearlings Got Plowed, a blog about Schering-Plough, the site’s author, Condor, weighed in: “Apparently the already-existing ‘black box’ warnings on the products may not be enough. Nor, it seems, should they be. My bet is that these will no longer be approved for use in children under the age of 12.”

Mayo Clinic addressed safety concerns last year when LABAs were in the news. The clinic said these types of drugs have been scrutinized since the 1970s, and the benefits can outweigh the risks for some people if the medicines are used properly.

“These are useful medications when they're used properly. LABAs should not be the only asthma controller medication you use — and they should only be used along with inhaled corticosteroids,” said Dr. James Li, an asthma specialist at Mayo Clinic.

The clinic’s bottom line: if you’re concerned about the safety of LABAs, talk to your doctor, and don’t stop taking the medications without consulting him or her first. For people with asthma, regular communication is also important, no matter what medicine you’re taking.

“If you have asthma, check in with your doctor at least once a year—especially if you are taking medications to control your symptoms,” Li said.

Related Topic: Singulair and suicide link

Earlier this year, the FDA opened an investigation into whether another asthma drug, Singulair, causes some users to have suicidal thoughts. In 2007, Merck changed the drug’s labeling to include suicidal thinking among the potential side effects.

Reference: Asthma information on the Web


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