Despite the fact that some Xarelto lawsuits have been coordinated in Federal
Court in New Orleans, while others have been coordinated in State Court
in Philadelphia, manufacturers Bayer and Johnson & Johnson continue
to push the FDA for Xarelto approvals. There are hundreds of lawsuits
on file with plaintiffs claiming adverse health issues and even death
as a result of taking Xarelto. In light of the fact that the number of
Xarelto lawsuits continue to rise, Bayer and Johnson & Johnson's
FDA request for expanded uses of Xarelto will be watched closely.
Will Bayer Receive a Fourth Rejection by the FDA for Expanded Use of Xarelto?
Earlier in 2014, Bayer and Janssen (a subsidiary of Johnson & Johnson)
were denied approval to expand the use of Xarelto to include those with
clogged heart stents and acute coronary syndrome. This was the third rejection
from the FDA for expanded uses of Xarelto which is currently only approved
to treat deep vein thrombosis or pulmonary embolism. Those who have had
a hip or knee replacement can also be prescribed Xarelto to prevent blood clots.
Xarelto Lawsuits Continue to Mount
Xarelto quickly captured the lion's share of the newer drugs in the
blood thinner market, due to the array of FDA-approved uses. Just last
year, Xarelto sales reached $1.5 billion. Because the drug is such a money-maker
for the manufacturers, they are pushing for further approved uses for
the drug. The latest push for yet another FDA approval comes amid serious
concerns regarding the lack of an antidote to potentially fatal bleeds,
as well as ever-increasing numbers of lawsuits in state and federal courts.
Xarelto Goes Head to Head with Aspirin
A new 7,000 patient trial will pit Xarelto against the common aspirin to
see which is more effective in the prevention of strokes. Despite warnings
regarding the use of Xarelto, the drug has already lured over one-third
of former Warfarin users and is working on the other two-thirds. Warfarin
is a much older blood-thinner which has been in use since the 1950's.
Warfarin works well, however patients must have regular blood testing
plus Warfarin reacts with some other foods and drugs.
Xarelto requires no regular blood testing, there are no known interactions
with other drugs and food, seemingly making it the clear choice. That
is, if you don't consider the issue of uncontrolled bleeds. A patient
taking Warfarin who is bleeding profusely can be given a shot of Vitamin
K to reverse the effects of the drug. There is no such antidote for the
person taking Xarelto. In the event of an uncontrolled bleed, doctors
have no way to stop the bleeding, and a significant number of Xarelto
users have bled out while doctors watched helplessly.
What Does the FDA Think About Xarelto?
The FDA has not been so quick to approve Bayer and Janssen's applications
for expanded usage of Xarelto due to the lawsuits filed as well as the
number of adverse event reports received. In addition to the last three
denials for expanded uses of Xarelto, the FDA has required the manufacturers
to state in the labeling that:
- When Xarelto is prematurely discontinued, thrombotic risks increase;
- When Xarelto is not taken with an evening meal, the patient could experience
decreased efficacy and,
- Patients who take Xarelto and receive neuraxial anesthesia or a spinal
puncture could have an increased risk of epidural or spinal hematomas,
resulting in long-term or permanent paralysis
Have you been harmed by Xarelto? Discuss your options with us at Golomb
& Honik, P.C.
when you call (215) 278-4449.