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this pageFDA Advisory Panel Votes to Continue Serevent® and Advair® Sales, Despite Safety Concerns
WASHINGTON, DC — August 12, 2005 — Despite safety concerns, a Food and Drug Administration Advisory Panel has voted to continue sales of the asthma drugs Advair® and Serevent®. These medicines contain salmeterol, an ingredient linked to increased deaths and life–threatening episodes among asthma patients.
Thirteen asthma patients out of 13,179 who took salmeterol died, according to statistics from one study (Salmeterol Multi–center Asthma Research Trial or SMART). By comparison, there were only three deaths among 13,176 asthma patients who took placebos. The deaths were due to severe asthma episodes and asthma–related problems. An analysis of subgroups suggests that the danger was most significant among Afro–American patients.
Information about SMART has been included in a “black box warning” on Serevent® and Advair® prescribing instructions since 2003. A black box warning is the highest alert that may be put on a label short of recalling the medication.
Dr. David Graham, a Food and Drug Administration [FDA] safety officer, testified before a Senate Committee about Serevent® and other drugs in November, 2004. He identified Serevent® as a dangerous drug that should be recalled because it may be aggravating the very condition that it was intended to help. “The scientific standards [the FDA] applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market,” he commented at that time (Washington Post, November 19, 2004; also see FDA Official Says Five Popular Drugs Are UnSafe),
How Serevent® and Advair® Are Used
Serevent® (salmeterol xinafoate) is a bronchodilator, a type of medicine used to help breathing in the bronchial airways and improve the passage of air into the lungs. The drug is approved for patients with asthma or chronic obstructive pulmonary disease (COPD). Inhaled twice a day, Serevent® is a powder that is intended for long–term maintenance, and not for sudden asthma episodes.
Advair® is also a bronchodilator that is inhaled twice a day. It is used by both asthma patients and those with COPD. Advair® contains salmeterol xinafoate, the medication in Serevent®, plus fluticasone proprionate, a steroid drug that may reduce inflammation. Again, the medication is meant for everyday use, not for sudden asthma attacks (Advair® Questions and Answers, GlaxoSmithKline).
Foradil® May Get a Black Box Warning
Foradil® (formoterol) is another asthma drug and bronchodilator. It also is used to ease the symptoms of COPD. Although Foradil® does not contain salmeterol, it is in the class of drugs called beta2–agonists, the same group that contains Advair® and Serevent®. Because of the close relationship between the three drugs, the FDA Advisory Panel recommended adding a black box warning to Foradil® prescribing instructions. The alert would explain that beta2–agonists have been linked to increased deaths among asthma patients.
Medical Drug Injuries
Brayton Purcell is concerned about the harm done by unsafe or ineffective prescription drugs. If you or a loved one has been injured by a defective medical drug, please feel free to contact us to learn about your legal options. We have been handling medical/legal cases for over 20 years, and work tirelessly to uphold the legal rights of our clients.