The FDA has-once again-expressed concern over the potential cardiovascular
risks associated with the drug Xolair. Xolair is an asthma drug, which
has been on the market since it received FDA approval in 2003. The drug
is manufactured and marketed by Genentech and Novartis, and currently
makes over $1.5 billion each year. Xolair is administered via injection
every other week, and used in place of steroid asthma inhalers.
Why is Xolair Still Being Marketed?
It is puzzling that Xolair is still on the market, still be used by asthma
patients and still bringing in staggering amounts of money for the manufacturer,
when as far back as 2009 the FDA indicated worry regarding the risks of
heart attack and strokes in those taking Xolair. In September 2014, the
FDA took further action, adding new warnings to Xolair's product labeling
which confirms the drug is associated with increased cardiovascular risks.
While the warnings are not contained in a black box warning, they are
listed in the adverse reaction section of the labeling, which is at least
a step in the right direction. Xolair has a prior black box warning from
2007 that relates to the high risk of anaphylaxis, which can be extremely
dangerous or even deadly. At least 48 adverse event reports related to
anaphylaxis among those taking Xolair are documented.
Is Corporate Greed Trumping Patient Safety?
The source of the new warnings is data from a five-year study, along with
twenty-five additional trials, which compared Xolair to a placebo. The
trials and study determined Xolair raises the risk of heart attack, chest
pain, pulmonary hypertension, heart attack, and blood clots. Unfortunately,
due to the specific manner in which the five-year study was designed,
the FDA is unable to say just how big those risks really are. While this,
in itself, will certainly not make patients feel very secure about taking
Xolair, the drug recently gained approval in Europe and the United States
to treat chronic idiopathic urticarial-a skin condition marked by chronic
hives. This latest approval for the use of Xolair prompted Novartis to
predict its dermatology division would soon be bringing in more than $2
billion in annual sales.
Does Xolair Cause Cancer?
The risks of Xolair anaphylaxis was known prior to the drug's FDA approval;
in pre-marketing clinical trials, serious anaphylaxis occurred in approximately
one out of every 1,000 patients, yet despite the risks, Xolair was allowed
on the market. There has also been concern related to the correlation
between Xolair and certain types of cancer. Prior to approving Xolair
for use in the United States, the original FDA safety officer's report
included the wording, "Comparisons of malignancy rates suggest-but
do not establish-an increased rate for Omalizumab (Xolair)-exposed subjects."
Apparently one clinical study showed the subjects taking Xolair experienced
more malignancies than the control group. Cancers were seen in one out
of every 200 subjects treated with Xolair-primarily breast cancer, skin
cancer and prostate cancer.
National Dangerous Drug Lawyers
You have a right to seek justice if you or someone you love has sustained
a heart attack or been diagnosed with cancer after taking Xolair. Drug
companies who routinely put profits before people should pay for their
negligence-and their unscrupulous behavior. To learn more about your legal
options or to schedule a free consultation call the
Philadelphia product liability lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national dangerous drug lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.