The manufacturers of the blood-thinning drug Xarelto are seeking to expand
the approved uses of the drug despite documented dangers. Bayer and Janssen-a
subsidiary of Johnson & Johnson-were denied approval earlier in 2014
when they applied to expand the use of Xarelto to include patients with
acute coronary syndrome and clogging of heart stents. This was the third
rejection by the FDA for an expanded use of Xarelto. Xarelto is currently
approved by the FDA
only for use in preventing or treating deep vein thrombosis or pulmonary embolism.
Patients undergoing a knee or hip replacement may also be prescribed Xarelto
as a means of preventing blood clots.
Financial Greed Trumps Patient Safety
The aggressive push to expand the use of Xarelto despite the growing number
of lawsuits being filed across the nation has to do with nothing more
than financial greed. While Xarelto has been on the market for a relatively
short period of time (the drug was introduced in late 2011), it has closed
in on blockbuster status. Sales of Xarelto are expected to top $1 billion
by the end of 2014, and FDA approval for expanded uses of the drug could
only boost sales further.
What's the Problem with Xarelto?
Xarelto has been identified as the cause in a number of fatal and near-fatal
bleeding incidents. Older blood thinning drugs like Warfarin and Coumadin
have been prescribed since the mid- 1950's, yet because the patients
taking those drugs must be monitored regularly and because the drugs have
certain food and drug interactions, many doctors are prescribing Xarelto
and similar drugs (Pradaxa) as an alternative. Xarelto can be prescribed
in a more standardized dose which is not dependent on the patient's
age or weight, requires no regular blood monitoring and has no known food
or drug interactions.
While this all sounds great, Xarelto has one very serious side effect the
older drugs do not. If a patient suffers an uncontrollable bleed while
taking Warfarin, doctors can administer a shot of Vitamin K, which reverse
the effects of the drug. Xarelto has no such reversing agent; when a patient
suffers an uncontrollable bleed, doctors can do nothing other than transfusing
blood to the patient and hoping the bleeding will stop on its own.
Black Box Warnings on Xarelto
The Xarelto labeling does include two black box warnings although neither
are related to uncontrollable bleeding. In 2012, fifty-eight deaths were
attributed to Xarelto use and in 2013, another 72. Current lawsuits claim
Xarelto is unreasonably dangerous and that the manufacturers have failed
to adequately warn patients of the potential risks of gastrointestinal
bleeding, rectal bleeding, brain hemorrhage, and other uncontrollable
bleeds. Further, the FDA has cited Xarelto manufacturers for distributing
promotional materials which were misleading or completely false.
It is not clear just how many lawsuits have been filed against the manufacturers
of Xarelto, although less than two weeks ago a group of 21 consumers petitioned
the U.S. Judicial Panel on Multidistrict Litigation to combine their lawsuits
into a single case. MDL status is often granted when the facts of the
individual cases are very similar. Despite the last three FDA rejections,
Bayer, Janssen and Johnson & Johnson intend to continue to push for
expanded uses of Xarelto, and have announced three new clinical trials
to prove the drug can be used to combat ACS and other problems. Those
harmed by Xarelto could benefit from speaking to a knowledgeable product
National Dangerous Drug Lawyers
If you have suffered medical complications, pain, or excessive bleeding
after using Xarelto, your injuries may be the result of a drug manufacturer’s
negligence. To learn more about your legal options or to schedule a free
consultation call the Philadelphia class action lawyers at Golomb &
Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.
The national dangerous drug lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.