Actemra is an injectable drug used for aduIts who suffer from rheumatoid
arthritis, and the resulting chronic inflammation. Actemra, granted FDA
approval in 2010, and manufactured by Roche and its Genentech unit, is
believed to work by blocking inflammatory agents in the body. Because
the more than 1.5 million Americans who take traditional prescription
drug treatments for rheumatoid arthritis suffer serious side effects such
as lung complications, heart attacks and heart failure, Actemra, which
initially appeared to have none of these side effects, was greeted with
delight by patients and doctors alike.
What these patients likely did not know was that health concerns regarding
Actemra first emerged in a 2009 Japanese study, before Actemra even received
approval from the FDA. In this study, 15 of the 5,000 study participants
died, and another 221 developed severe side effects such as pneumonia
and high fever. Another study, published just a month ago by STAT, indicated
that the complications associated with Actemra couId well be as high—or
even higher—than similar drugs, such as Vioxx.
Further, the current competing drugs mostly warn patients of the potential
risks, while Actemra fails to do so. Vioxx also failed to disclose potential
risks to patients. The drug Celebrex quickly took Vioxx’s spot,
and is still on the market today, although there has been a drop in the
number of prescriptions after information about NSAIDs’ link to
adverse gastrointestinal side effects came to light. What Actemra and
Vioxx also seem to have in common is that it took a long time for the
risks surrounding Vioxx to emerge—and the risks associated with
Actemra couId cost the manufacturer.
The manufacturer of Vioxx, MSD, made approximately $11 billion in revenues
during marketing, but has already spend a reported $6 billion in litigation.
According to the STAT report, out of the 13,500 side-effect reports for
Actemra, 1,128 patients taking the drug died. A 2016 study indicated that
Actemra patients had 50 percent more heart attacks and strokes than patients
taking Enbrel, yet Enbrel’s labeling has prominent warnings about
a patient’s potential for developing cardiovascular disease when
taking the drug. The numerous serious side effects associated with Actemra
include the following :
- Heart attack
- Heart failure
- Gastrointestinal perforation
- Interstitial lung disease
Additionally, more than 5 percent of Actemra patients experience injection
reactions, increased ALT blood levels, high blood pressure, runny nose,
upper respiratory tract infections and headaches.
Is Genentech Guilty of Failure to Warn?
At this point, it appears Genentech was aware of the adverse health issues
associated with Actemra, yet continued marketing the drug to the public.
The current Actemra lawsuits are making the assertion that Genentech failed
to warn physicians and patients of the serious side effects associated
with Actemra, and it appears the FDA couId potentially be on the hook
for failure to warn as well. While the FDA is supposed to monitor the
safety of prescription drugs, the agency often fails to verify the side-effect
reports it receives. As an example, a 73-year old man suffered a fatal
brain bleed just two days after receiving an Actemra injection, yet despite
this—and many other similar reports— neither Genentech nor
the FDA has made any move to change the label on Actemra in order to alert
patients to the potential risks.
If you or a loved one has suffered serious injury after taking Actemra,
it is important that you contact an experienced Philadelphia dangerous
drug attorney as soon as possible. Your attorney will work hard on your
behalf to secure the settlement you are entitled to.
To learn more about your legal options or to scheduIe a free consuItation
with an attorney, please call the Philadelphia dangerous drug lawyers
at Golomb & Honik, P.C. today at (215) 278-4449 or fill out our confidential
The national dangerous drug lawyers at Golomb & Honik, P.C. have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.