Advair® Warning
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An Advair® warning was initially made after studies suggested that a medication with the same active ingredient increased a patient's risk of suffering a serious asthma or respiratory related episode or death. In 1996, a study comparing Serevent and a placebo found a small but significant increase in serious life threatening side effects for those taking Serevent. Because this side effect was considered a class effect, an Advair® warning was also issued.
Advair® and Serevent are both long acting bronchodilators produced by pharmaceutical giant GlaxoSmithKline. The active ingredient shared by both is salmeterol, a beta-2 agonist, which is supposed to relax and open the airways. Both of these drugs were approved by the FDA to provide maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). According to GlaxoSmithKline, over 27 million prescriptions of Advair® were sold in 2004 alone.
The official Advair® warning came in August 2003 when the FDA ordered the addition of a box warning to all product information. The black box Advair® warning is the strongest warning the FDA can order short of a drug recall. This Advair® warning informed consumers about clinical trial evidence of a rare increase in life threatening side effects associated with this medication.
The Advair® warning also informs consumers about the proper use of long acting bronchodilators. Advair® is not designed to treat acute symptoms or deteriorating asthma. Inhaled corticosteroids and short-acting bronchodilators should be used in conjunction with Advair® as directed by a medical professional. Patients in a higher risk group, such as African American patients, should speak to their physician about the Advair® risk and whether use of this medication should be continued.
After the black box Advair® warning was added to all patient information, the FDA convened an advisory panel to consider whether or not Advair®, Serevent, and Foradil should remain on the market. The panel of fourteen respiratory experts evaluated all current available information about the safety and efficacy of these medications. After reviewing this information, the panel voted unanimously to allow these drugs to remain on the market. The group recommended that further research be carried out to learn more about the respiratory effects of these drugs.
The current Advair® warning informs patients of the aforementioned serious risks and other, more common, side effects associate with this medication. Common side effects that can be experienced by patients using Advair® include: irritation and infection of the eyes, nose, and throat, headaches, dizziness, stomach upset, nervousness, increased heart rate, shakiness, and respiratory infections and irritation.
If you or a loved one is taking Advair® and you are concerned about the Advair® warning, you may wish to speak with your physician in greater detail. If you have been injured by Advair®, please contact us to speak with a qualified and experienced attorney near you.
