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Serevent Lawsuit and Side Effect Information
Serevent side effects include the unexpected worsening of an asthma attack. In one case this caused a Serevent lawsuit to be filed on behalf of a patient...
Serevent Overview
Serevent (salmeterol xinafoate) is usually prescribed for the treatment of asthma and chronic obstructive pulmonary disease, it has relatively few off label uses other than this.
Salmeterol has been on the market since the 1980s and was formulated into Serevent in 1990 by GlaxoSmithKline. GlaxoSmithKline launched the drug in 1994, then started a safety study on it in 1996. It abruptly stopped the study due to life threatening adverse reactions including death.
The safety study was stopped because of the higher incidents of adverse reactions in African-Americans and because it was hard to enroll patients. There were 13 deaths and 37 instances of life threatening asthma in the Serevent treated group. These figures translated into 5 times as many deaths and near deaths from asthma in the African America participants.
The FDA told GlaxoSmithKline to update their labels to a black box warning which initially wasn't done until 2003. The FDA position was that while Serevent decreases how often asthma attacks happen, the inhaler may make them more severe. Study participants were considering filing a Serevent lawsuit.
In 2004 the FDA ranked Serevent as being among the top five most dangerous prescription drugs on the market, with FDA physician Dr. Graham commenting that the warnings needed to be more stringent.
In November of 2005, the FDA issued a health advisory to the public telling them that Serevent could lead to a worsening of asthma symptoms, and in some cases death. A health advisory is a warning of sorts, but not a black box warning where the drug manufacturer is required to put the warning on the patient information leaflet with the drug.
It still remained on the market with more black box warnings being added in March 2006 indicating Serevent may increase the risk of asthma related death. By this time many patients were asking their lawyers about filing a Serevent lawsuit.
In June 2006, Cornell University and Stanford University researchers reported Fluticasone/salmeterol (Advair / Serevent) increased the risk of respiratory death more than twofold in treating chronic obstructive pulmonary disease.
Serevent sales for 2006 were quite healthy, ringing cash registers to the tune of $538 million with 3% of that figure being Serevent dispensed to children. Statistics indicate that approximately 779,006 Americans 16 and younger were taking this drug between April 2006 and March 2007.
Serevent Side Effects & Other Problems
Serevent seems to display a mixed bag of adverse reactions that include anaphylaxis, headaches, tremors, dry mouth, nausea, sweating, hives and dizziness. In addition patients may have a higher risk of dying from asthma related problems if they are also taking anti-inflammatory medicines.
More particularly this seems to apply if a patient attempts to use Servent to treat an acute asthma attack. Evidence indicates doing this may worsen the episode and may cause death.
Other reactions to Serevent have been tremors, chest pain, irregular/fast heartbeat, raised blood pressure, nervousness, shaking, abnormal heart beats, low blood potassium levels, muscle cramps and sudden narrowing of the airways (called paradoxical bronchospasm). This list is not all-inclusive.
The Serevent inhaler with chlorofluorocarbons was discontinued in January 2006 and replaced by the Serevent evohaler. By this time a lot of people using this drug were having their claims assessed for filing a Serevent lawsuit.
Lawsuits of note against GlaxoSmithKline have been and are for:
* Paxil/paroxetine - anti-depressant, also used for children
* Wellbutrin/Zyban - anti-anxiety and stop smoking drug
* Class action lawsuit - Medicaid fraud in 40 states for inflating the price of cancer drugs and other drugs
* Biota Drug Company - for not achieving market share for flu vaccine Relenza
* Avandia - diabetic drug that caused liver failure
* Relafen - anti-inflammatory for arthritis
* Proctor & Gamble - lawsuit over Boniva (osteoporosis drug) ads
* Antitrust Class Action - lying to patent office to delay generic Wellbutrin from hitting the market
Serevent Lawsuits
No one seems to really know what causes the Serevent side effect of narrowing the airways when it's supposed to relax and open them. While it appears there are no Serevent cases as of yet, except for one filed in 2005, there is the potential for more.
This drug was on the market for 9 years before warnings were issued about its possible deadly side effects. Evidence such as this is much sought after in filing a Serevent lawsuit. Grounds for filing would include that Serevent is defective and unreasonably dangerous.
Reportedly there have been up to 4,000 Serevent related deaths. Attorneys across the US are investigating these alleged deaths and Serevent side effects. They are asking those who have been hurt by Serevent, or have lost a loved one, to contact them about the possibility of filing a Serevent lawsuit.
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