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FDA Issues Warning on Advair, Foradil, Serevent and Symbicort

These four popular asthma drugs Advair, Foradil, Serevent, and Symbicort received new warning labels from the U.S. Food and Drug Administration in February 2010. The FDA warns asthma suffers to avoid using these medicines as a sole or long-term means of symptom control. These asthma medicines are in the long-acting beta agonists (LABAs) class of drugs. If you, or your child, is using one of these drugs as a sole means of controlling asthma symptoms you should contact the prescribing physician immediately. The FDA warns that regular use of any of these four asthma medications can increase the severity of asthma. Ultimately, the long-term sole use of LABAs to control asthma symptoms can lead to hospitalizations and even the death of some asthma sufferers.
The FDA strongly suggest that any of these drugs be used for the shortest time possible to control asthma. Once asthma symptoms are under control LABAs should be discontinued and other asthma medications should be used to control symptoms. The FDA wants to maintain the availability of LABAs for asthma suffers whose symptoms are not adequately controlled by other medications and encourage safe use of these products. This warning does not apply to those using these drugs for chronic obstructive pulmonary disease (COPD).
According to the FDA most people only require an inhaled corticosteroid to control asthma symptoms. LABAs improve breathing and reduce asthma symptoms by relaxing the lung's airway muscles.
The makers of the four drugs will have to add this 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 people whose asthma is not controlled by other drugs.
- They should be used for the shortest time possible to bring asthma under control, and then other asthma drugs should replace them.
- Children and adolescents who need these drugs should use only combination drugs that contain both a LABA and a corticosteroid.
“Thursday's announcement follows an FDA advisory panel decision in December 2008. The panel found that the risks linked to single-agent Serevent and Foradil outweighed their benefits for children and adults. At the time, Advair and Symbicort were excluded from that decision.”
Photo Credit: Julia Fuller
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