When the FDA first approved Xolair for the treatment of asthma in 2003,
asthma sufferers everywhere were hopeful that this would help them manage
their asthma symptoms. It was supposed to be primarily helpful for individuals
whose asthma could not be controlled well with inhaled corticosteroids.
Now, however, it seems that asthma patients taking Xolair could be at
a higher risk for developing heart attacks, strokes, and other life-threatening
injuries. This news recently prompted the FDA to begin an investigation
into Xolair and its dangerous side effects.
Our national dangerous drug attorneys at Golomb & Honik, P.C. are currently
investigating Xolair claims. If you or someone you love has suffered a
heart attack or stroke after taking Xolair, call (215) 278-4449 to get
your case reviewed for free by one of our attorneys.
Fill out a complimentary case evaluation form here.
What is Xolair?
Xolair is a drug prescribed for the treatment of moderate to severe asthma.
Patients with asthma produce too much of a specific protein known as IgE.
It is believed this protein contributes to a variety of allergic conditions
including hay fever, asthma, venom sensitivity, and food or drug allergies.
Xolair works by blocking the action of the IgE, thus treating those with asthma.
Xolair is used in adolescents over the age of 12 and adults, and is given
via injection in the upper arm, every two to four weeks. According to
patient information, it can take several months before patients begin
to notice significant benefits from Xolair. Xolair is extremely expensive,
costing approximately $2,100 per dose along with an injection fee of about
$200. Even those with insurance will likely pay a certain portion of the cost.
Side Effects of Xolair
Xolair contains a black box warning, mandated by the FDA, for the potential
risks of anaphylaxis, or severe allergic reaction. The symptoms of anaphylaxis
include: tightness of the chest, trouble breathing, wheezing or gasping
for air, skin rash, hives, dizziness, warmth or tingling of the skin or
swelling of the throat, face, lips or tongue. Anaphylaxis is extremely
serious as it can lead to death. Other potentially serious side effects
associated with Xolair include bruising easily, unusual bleeding, numbness,
Dangers Associated with Xolair
Along with the potential side effects, there are more serious dangers associated
with the use of Xolair. The FDA approved Xolair in 2003, and by February
2007, after receiving more than 48 adverse event reports of anaphylaxis,
required Novartis and Roche to add a black box warning to the labeling
regarding the risks associated with anaphylaxis. The FDA noted a disturbing
frequency of anaphylaxis, as well as the risk of a delayed onset of adverse
reaction from the drug.
Most recently, the FDA evaluated information from a five-year study and
twenty-five clinical trials, which compared Xolair to a placebo. These
studies determined Xolair increases the chances of cardiovascular problems,
including heart attack, stroke, blood clots, and pulmonary hypertension
which can be immediately life-threatening. While the FDA is requiring
Novartis and Roche to add these risks to the "adverse reaction"
labeling area, a black box warning is not yet mandated.
The FDA has stated that due to certain flaws in how the five-year study
was constructed, they cannot make a determination regarding just how serious
the cardiovascular risks actually are. As such, they are beginning an
investigation into these claims.
There has also been a link established between Xolair and certain types
of cancer; in one study approximately one in 200 patients developed prostate,
breast or skin cancer. This study was also found to have "flaws,"
in that the patients were not tested for cancer prior to taking Xolair,
so pre-existing cancers cannot be ruled out.
How Our Product Liability Lawyers Can Help
Novartis and Roche brought in more than $1.5 billion last year alone from
sales of Xolair, so there is little motivation to engage in clinical trials,
which could prove the dangers associated with Xolair. Further, the drug
is likely to generate even more revenues as the United States and Europe
just approved the drug for use in the treatment of chronic hives.
If you or a loved one has suffered a heart attack, stroke, or cardiovascular
injury after using Xolair, it is important to speak to a knowledgeable
product liability attorney immediately. At Golomb & Honik, P.C., our
Philadelphia product liability lawyers will comprehensively evaluate the
specific circumstances regarding your use of Xolair, in order to determine
whether you have a viable case against the manufacturers of Xolair.
Contact us today at (215) 278-4449.