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There is a new warning-label requirement for makers of certain asthma drugs. The U.S. Food and Drug Administration announced last Thursday that it will be requiring manufacturers of long-acting beta antagonists (LABAs) to include a warning in the product labels that these drugs should never be used alone in the treatment of asthma in children or adults.
This new warning requirement comes in the wake of FDA clinical trials that showed an increased risk of severe worsening of asthma symptoms, which could potentially lead to hospitalization in children as well as in adults. In the worst case scenario, the use of the drug could result in death.
The FDA calls for the limitation in use of these drugs, and calls for the use of other drugs in combination with these drugs to treat asthma. As the warning label must reflect, the LABA drugs should only be used for the most minimal period necessary.
According to the FDA website, the following warnings must be made by the drug-makers:
Drugs affected by this warning requirement include Foradil, Serevent, Advair and Symbicort.
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