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Advair Class Action Lawsuits Information
An FDA advisory committee met in July 2005 to decide if
Advair should remain on the market. Advair is the brand name drug combining
fluticasone and salmeterol to prevent wheezing, shortness of breath and
breathing difficulties caused by asthma. Made by GlaxoSmithKline, Advair
contains the same drug - salmeterol - that is found alone in another Glaxo
asthma drug called Serevent. Concerns have risen regarding the use of Advair
because the FDA said a small number of patients have had severe asthma
exacerbations.
Fluticasone is in a class of medications called steroids and is supposed to
reduce swelling in the airways. The salmeterol is in a class of medications
called long-acting beta-agonists and is supposed to relax and open air passages
in the lungs, making it easier to breathe.
In a large clinical study, the use of Advair was found to cause a small increase
in deaths from asthma in patients who used salmeterol. If patients have asthma
that is quickly getting worse, the use of the drug combination should be
avoided. Advair is inhaled to keep the airways open to prevent asthma attacks,
not to cure it.
A black-box warning, the FDA's strongest issued drug warning, was added to
Advair labels in 2003, based on preliminary results of the Salmeterol
Multicenter Asthma Research Trial. The Advair warning labels were issued after
the post-marketing study of Serevent study showed a small number of patients
experienced severe exacerbations of their asthma, and it suggested
African-Americans were particularly at risk.
The number of deaths in Advair patients was considered small but significant,
revealing people who added the drugs to their usual treatment suffered 13 deaths
in 13,176 patients versus 3 in 13,179 who took placebos. In November 2004, FDA
whistleblower Dr. David Graham singled out Serevent as one of five drugs that
may be linked to serious safety concerns when testifying about what he called
the FDA's inability to protect the public from unsafe drugs.
The FDA asked its advisory panel to review the safety of Advair, as well as
Serevent and Novartis' asthma drug Foradil. The committee of 14 asthma experts
convened on July 13, 2005 and reviewed the data on the drugs, listened to
presentations from the manufacturers and others.
While the FDA does not have to listen to its advisory committee's
recommendations, the agency usually does. After meeting, the panel unanimously
recommended the three drugs, including Advair, remains on the market, but the
committee urged more research to determine whether the medications might
actually worsen asthma in certain patients.
In 2004, Advair's U.S. sales reached $2.4 billion, and its worldwide sales of
more than $4.5 billion made it the third best selling drug in the world. From
July 2004 to July 2005, 17.2 million Advair prescriptions were filled. More than
21 million adults and eight million children in the U.S. have asthma.
Advair Side Effects
Advair side effects may range from common deleterious
symptoms to serious and life threatening complications. GlaxoSmithKline's Advair
is a long acting bronchodilator approved in 2000 to treat patients with asthma
and chronic obstructive pulmonary disease. Nearly fifty million Americans suffer
from one of these conditions. In one year alone, over 17 million prescriptions
of Advair were written for patients in the United States.
The most common Advair side effects can cause irritation and inflammation of the
ears, nose, and throat. Bronchitis and lower respiratory infection may also be
caused by Advair side effects. The gastrointestinal system can also be adversely
affected by Advair side effects. Some patients may experience upset stomach,
vomiting, diarrhea, and nausea from this medication. Additional Advair side
effects include: headaches, dizziness, increased heartbeat, shakiness,
nervousness, muscle cramps and bone pain.
There are also more serious Advair side effects that can lead to serious injury
or death. There are two active medications in Advair: fluticasone, an
anti-inflammatory steroid and salmeterol, a long acting beta-2 agonist
bronchodilator. The latter, salmeterol, has been linked to more than a dozen
deaths caused by fatal asthma attacks brought on by the medication itself.
In 1996 the maker of both Advair and Serevent designed a 28-week clinical study
to measure the effects of Serevent (whose only active medication is salmeterol)
and a placebo. The study discovered that patients in the Serevent group had a
rare, though significant, risk of suffering a serious asthma episode or death
brought on by the medicine. African American patients seemed to be at an even
greater risk.
Because Serevent and Advair share the same active ingredient, the side effects
discovered in this study were assumed to be a class effect that may also be
relevant for patients taking Advair. In 2003, the FDA ordered a black box
warning to inform patients about Serevent and Advair side effects.
This warning also informs consumers that Advair does not replace, or have the
same effect as, short acting bronchodilators or inhaled corticosteroids. People
with deteriorating asthma should not use Advair, since this medication is not
appropriate for acute or serious respiratory conditions.
In 2005, an FDA advisory panel of fourteen respiratory experts convened to
consider whether Serevent, Advair, and a similar drug called Foradil should
remain on the market. After analyzing current available information on these
respiratory medications, the panel voted unanimously to allow the drugs to
remain on the market. They also suggested that more studies be conducted to
learn more about Advair side effects and those of similar respiratory
medications.
More Advair Information
Consumer Advair information was updated in 2003 to include
strong warnings about this drug's serious and life threatening side effects. The
original Advair information offered to consumers by GlaxoSmithKline (the maker
of both Advair and a similar drug, Serevent) detailed the drug's use,
contraindications, common side effects, and drugs which may affect the function
of Advair with concurrent use.
Advair is a blockbuster respiratory medication approved by the FDA in 2000 to
treat the symptoms of asthma and chronic obstructive pulmonary disease. Advair
combines two active medications to deliver effective treatment. Fluticasone is a
steroid that reduces inflammation in the airways. Salmeterol is a long acting
beta-2 agonist bronchodilator that relaxes and opens the airways to improve
breathing.
Advair information states that Advair will not stop an asthma attack already in
progress. Advair is a long acting bronchodilator that is intended to prevent
asthma attacks from occurring. Advair information indicates that this drug is
not a replacement for inhaled corticosteroids or short acting bronchodilators.
Increased need to use the latter products may indicate the worsening of a
patient's condition. In these cases, a patient should speak to their physician.
Advair information also states that patients should speak with their health
professional about their full medical history before commencing treatment.
Patients who have or have had any of the following should discuss their
condition with their health care provider: any type of infection, previous
allergic reaction to similar medicines, seizure disorder, glaucoma, diabetes,
tuberculosis, thyroid problems, or liver disease. Certain medications may also
alter the effect of Advair on the body. Therefore all current and recent
medication use should also be discussed with your health care provider.
Advair information also indicates a number of common side effects that may be
experienced while taking this drug. Common Advair side effects include:
infection or irritation of the eyes, nose, or throat, headache, rash,
gastrointestinal upset, muscle cramps, chest pain, rapid or irregular heart
beat, shakiness, nervousness, or an aggravation of the symptoms this drug is
intended to treat.
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