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Foradil: Warnings
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"I have concerns that, until proven otherwise, we have to make ourselves believe that Foradil may act the same way" as Serevent, said panel member Steven Gay, a lung specialist with the University of Michigan Health System. The FDA usually follows its advisory panels' recommendations.
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The safety of Foradil during pregnancy and lactation has not yet been established. Its use during pregnancy should be avoided unless there is no safer alternative. Like other beta2-adrenergic stimulants, eformoterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
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Formoterol is available with a prescription under the brand name Foradil. Other brand or generic formulations may ... be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
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Eformoterol, the active ingredient of Foradil, belongs to the class of long-acting beta2-adrenergic agonists. In a study with salmeterol, a different long-acting beta2-agonist, a higher rate of death due to asthma was observed in the patients treated with salmeterol (13/13176) than in the placebo group (3/13179). No study adequate to determine whether the rate of asthma-related death is increased with Foradil has been conducted.
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The committee members felt that adding a warning to Foradil would alert physicians and patients that the drug might be no safer than Salmeterol products. The burden should be on Novartis to show that Formoterol has a different mechanistic or safety profile from Salmeterol, committee members said. The committee members ... recommended the dissemination of more physician and patient information on the risks of Salmeterol products, including a patient medication guide.
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