FDA Issues New Label Warnings for Popular Asthma Drugs

< Feb. 24, 2010 > -- The U.S. Food and Drug Administration (FDA) is cautioning patients concerning the use of four widely prescribed asthma medications.

The FDA is requiring a new warning label on Advair, Serevent, Foradil, and Symbicort. All of these drugs are known as long-acting beta agonists (LABAs). Advair and Symbicort also contain an inhaled corticosteroid.

LABAs Appropriate for Combined and Short-Term Use Only

According to the agency, LABAs should not be used alone to treat asthma in adults or children. The FDA cited studies that reveal using the drugs by themselves can actually increase the severity of asthma symptoms, leading to hospital visits or even death.

LABAs should also be used for the shortest time possible to get asthma symptoms controlled, according to the FDA. They should then be discontinued, if possible, once asthma control is achieved.

"We think the overall public health benefit is to reduce the use of LABAs," explains John Jenkins, M.D., director of the FDA's Office of New Drugs in the Center for Drug Evaluation and Research.

"As we weighed the risks against the benefit of the drug, we recognized that there is still benefit for these products in patients who aren't adequately controlled on asthma controller medications," Dr. Jenkins says. "We wanted to maintain availability of these products, while also encouraging the safe use of the product."

What the New Warning Labels Say

Drug makers are required to add the following information to their product labels:

• These drugs must be used along with other asthma medications such as an inhaled corticosteroid.
• The drugs should only be used in patients whose asthma is not controlled by other drugs.
• They should be used for the shortest time possible to bring asthma under control, then replaced with other asthma drugs.
• Children and adolescents who need the drugs should use only combination drugs that contain both a LABA and an inhaled corticosteroid.
  

Although the drugs are also approved for use in chronic obstructive pulmonary disease (COPD), this warning only applies to their use for asthma. 

Asthma Medications: What Experts Recommend

Most people with asthma need daily long-term control medication to prevent symptoms. Drugs that reduce inflammation in the airways, such as inhaled steroids, generally offer the most benefit. While they don't offer quick symptom relief, these medicines can prevent symptoms from starting when taken over a long period of time. They help prevent the chain reaction that causes asthma symptoms.

Inhaled steroids -- also known as corticosteroids -- are usually preferred by doctors to control asthma. They are considered safe when taken as prescribed. Examples of corticosteroids include Asmanex, Azmacort, Flovent, and Pulmicort. 

For fast-acting symptom relief, inhaled beta2-agonists, or bronchodilators, are usually the first choice. These drugs relax tight muscles around the airway, so air can flow through. Examples of these are Albuterol, Maxair, and Xopenex HFA.

People with asthma should carry a quick-relief inhaler at all times and use it when at the first sign of asthma symptoms.

Talk with your doctor for more information about how to stay in control of your asthma.