Orlistat
Side Effects
Orlistat (also referred
to as Xenical) is a lipase-inhibitor
drug designed by Hoffman
La-Roche Laboratories to
help obese individuals lose
and maintain their body weight.
The drug works by preventing
fat from being absorbed by
the body but can cause excess
gas, oily discharge and other
gastrointestinal problems.
Although this may sound like
a miracle weight loss drug,
it has hidden cancer risks
which are emerging that clearly
outweigh any possible benefit
the drug may have. According
to research studies, people
who use it have a higher
risk of developing both colon
cancer and breast cancer.
A Product Liability Lawyer can help with:
Have you or
someone you know suffered
from Orlistat Side Effects? Contact
us for a free consultation
on your potential case against
Orlistat Side Effects today!
Colon cancer concerns have
spurred the consumer advocate
group, Public Citizen, to
petition the FDA asking it
to withdraw the prescription
diet drug from the market;
the group also wants the
FDA to refuse approval for
the weight-loss pill to be
made widely available over
the counter. Public Citizen
has a strong track record
of identifying dangerous
drugs well before federal
regulators take action to
ban or put warnings on these
drugs. For example, Public
Citizen warned consumers
about the dangers of Vioxx,
Ephedra, Bextra, Rezulin,
Baycol, Propulsid and many
other drugs years before
the drugs were pulled from
the market. Public Citizen,
representing over 100,000
consumers in this petition,
has moved forward with the
petition based on research
that shows people taking
Orlistat have a significant
risk of developing aberrant
crypt foci. Aberrant crypt
foci has been found to be
a precursor to colon cancer.
Orlistat side effects has
also been determined to be
associated with higher risks
of developing breast cancer.
Data from Hoffman La-Roche’s
clinical studies showed that
It accelerated the development
of breast cancer in women
over 45 years of age or older
when given the medication
orally at a dose of 120 milligrams
three times per day. This
data initially gave the FDA
concern and it held off on
approving the drug. In the
seven randomized, controlled
clinical trials, there were
10 cases of breast cancer
in the treated group with
only one in the control group.
The relative risk of getting
breast cancer while taking
Orlistat (compared to those
taking a placebo) was calculated
several times by both the
FDA and the sponsor and found
to vary between 4 and 7 fold,
depending on the analysis.
These results caused the
FDA Medical Officer to rescind
his original approval. However,
the FDA recommended that
the warning labels contain
information related to this
risk, also asked for post
marketing surveys to be conducted.
No such warnings were included
in the products labels, and
to the present date no post
marketing surveys have been
performed.
Have you or
someone you know suffered
from Orlistat Side Effects? Contact
us for a free consultation
on your potential case against
Orlistat Side Effects today!
Michael Gunzburg is
a New York Orlistat Recall
Attorney serving the New
York Metropolitan area,
including New York
City, Bronx, Brooklyn,
Manhattan, Queens, Staten
Island, Nassau, Suffolk,
Westchester, Rockland and
Orange County.
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