Asthma drug concerns prompt new safety restrictions

Consumer Reports News: February 18, 2010 07:07 PM

If you or your child uses a certain type of asthma medication that contains a drug known as a long-acting beta agonist, or LABA for short, (such as Foradil or Serevent) be aware: it should only be used with other medication, never alone. And for all LABAs, including Advair and Symbicort (two products which combine an LABA with an inhaled steroid) should be used for the shortest time possible to reduce the chance that they could severely worsen asthma symptoms. If any of these drugs is not used appropriately, it could lead to serious medical problems, hospitalization and even death in children and adults, according to new safety restrictions the Food and Drug Administration issued Thursday.

The FDA also underscored that LABAs do not relieve sudden-onset asthma symptoms, and recommends instead using a rescue inhaler, such as albuterol inhaler, instead.

The new FDA restrictions apply to four drugs: salmeterol (Serevent) and formoterol (Foradil), which contain only an LABA, and the combination medications, salmeterol/fluticasone (Advair) and formoterol/budesonide (Symbicort), which contain both a LABA and an inhaled corticosteroid. The labeling of these drugs will now carry a warning that single-agent LABAs should not be used alone and should instead be used in combination with an asthma controller medication, such as an inhaled corticosteroid.

The warning will also note that LABAs should only be used long-term in people who have been unable to control their asthma symptoms with an asthma controller medication, such as an inhaled corticosteroid. And if an LABA is necessary, they should only be used for the shortest time possible. After which, the person should switch to an asthma controller medication.

In addition, the FDA warning will recommend that children and teens who need a LABA should use one of the combination drugs (Advair or Symbicort) to make sure they’re taking both drugs to reduce their risk of problems.

About 22 million people have asthma in this country and that includes roughly 6.5 million children. This chronic disease continues to be a huge, growing problem in the U.S. and there are many medications available to treat this condition.

"The risks of hospitalization and poor outcomes are of particular concern for children; parents need to know that their child with asthma should not be on a LABA alone," said Dianne Murphy, director of the FDA’s Office of Pediatric Therapeutics.

The FDA said it is also requiring manufacturers of LABAs to conduct additional studies to determine their safety when they are used in combination with inhaled corticosteroids. The agency also plans to monitor prescribing practices to make sure doctors are abiding by these new safety recommendations.

Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs 

To learn more about inhaled corticosteroids for treating asthma, check out our free Best Buy Drugs report.

Photo: GlaxoSmithKline

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