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Foradil: Drugs
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Although Advair®, Foradil®, and Serevent® decrease the frequency of asthma attacks, these medicines may make asthma episodes much more severe when they do occur, the FDA warns. In one study, patients took salmeterol, an active ingredient in both Advair® and Serevent®. Salmeterol users were more likely to need respirators or ventilators due to severe asthma attacks than did asthma patients who took fake pills or placebos. Four times as many salmeterol users died compared to those who did not take the drug.
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In a post-marketing study of Serevent and the final phase of Foradil's pre-approval studies, a small number of patients experienced severe exacerbations of their asthma. The much larger Serevent study suggested that African-Americans were particularly at risk. As a result of the post-marketing study's findings, a black-box warning — the strongest type of drug warning — was added to Serevent's and Advair's labels in 2003.
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If Foradil is taken with certain other drugs, the effect of either may be increased, decreased, or altered. It is especially important to check with your doctor before combining Foradil with the following:
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Foradil received FDA approval on February 16, 2001 to treat asthma. The FDA’s Pulmonary-Allergy Drugs Advisory Committee said on July 13, 2005 that Foradil, manufactured by Novartis; (Generic: Formoterol), should add a “black box” warning stating safety issues associated with GlaxoSmithKline’s Serevent, a similar drug in the class.
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In July of this year, an FDA advisory panel met to discuss health problems caused by Advair®, Foradil®, and Serevent®. It recommended a “black box” warning on the prescribing instructions for Foradil®. That is the most urgent alert short of withdrawing a drug from the market. Black box warnings about asthma–related deaths are already included in the Advair® and Serevent® prescribing instructions. The panel ... noted that all three drugs increased the risk of severe asthma episodes. Nevertheless, the panel voted to keep the asthma drugs on the market.
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As a followup to last Wednesday’s post the panel assembled to ascertain whether or not Serevent, Advair, and Foradil should remain on the market voted unanimously to keep the three drugs available, citing an acceptable risk/benefit ratio. The panel ... did not recommend any changes to the products or their packaging. This is good news for the estimated 20 million asthma sufferers in the United States.
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