Actemra, like many other drugs marketed for rheumatoid arthritis, appears
to have a significant number of complications and risks associated with
the drug. Despite this, neither the manufacturers of Actemra—Roche
and its subsidiary, Genentech— nor the FDA has made a move to withdraw
Actemra from the market, or even to add warnings to the labeling of Actemra.
A recent study done by STAT resuIted in those who examined the data advising
the FDA to consider Actemra warnings regarding pancreatitis and heart failure.
Inflammation of the pancreas in its acute form, can kill half of all patients
who develop the inflammation. Further, Actemra appears to also increase
the risk of stroke, interstitial lung disease, and heart attack. Interstitial
lung disease is a scarring of lung tissue, which can sometimes be fatal,
and although the link between interstitial lung disease and Actemra has
not been proven, it certainly warrants further review.
Failure to Warn by Genentech and the FDA
A failure to warn the public by the manufacturer of Actemra and even the
FDA have resulted in a number of lawsuits against Genentech. Experts say
the FDA’s inability to determine whether prescription drugs are,
in fact, safe, and the inability to act promptly when potentially dangerous
side effects come to light, put the agency in the hot seat as well, although
they are not included in the current lawsuits.
Despite the FDA’s struggle to strengthen drug monitoring, the agency
has had little success, and does not have the ability to significantly
track drug safety once a drug is on the market. Because the new administration,
as well as members of Congress, are attempting to push drugs through regulations
even faster, it is likely we will see many more issues like the ones facing
the manufacturers of Actemra.
Actemra is the Fifth-Highest Grossing Drug for Genentech and Roche
Actemra is currently taken by more than 760,000 patients, generating sales
of $1.7 billion just last year, and making it the fifth-highest grossing
drug for Roche and Genentech. Although Actemra is primarily used in the
treatment of rheumatoid arthritis, the drug is prescribed off-label for
another 60 or so conditions, and the drug has not been tested for safety
and efficacy for these conditions.
Serious Side Effects Associated with Actemra
Rheumatoid arthritis is an autoimmune disease which causes joint stiffness,
swelling and pain, and while Actemra may not be more dangerous than other
arthritis drugs, many doctors and patients are under the mistaken impression
that Actemra is safe, simply because there are no warnings on the labeling
of Actemra. Yet as far back as 2010, in a review of millions of reports
to the FDA involving more than 100 drugs, Actemra stood out. This review
found that Actemra patients experienced an unusually high number of serious
As an example, Actemra users report about the same number of interstitial
lung disease problems as Humira users, and more than Remicade, however,
unlike those two drugs, Actemra does not warn of the potential for developing
interstitial lung disease. There were similar results for heart failure,
strokes and heart attacks. While Humira and Remicade warn about those
potential problems, again, Actemra does not. Perhaps even more alarming,
132 patients who have taken Actemra died from pancreatitis—a very
rare, life-threatening disorder, usually triggered by high cholesterol levels.
Getting the Help You Need Following Actemra Injuries
If you have suffered injury from the drug Actemra, it is important that
you speak to a knowledgeable Philadelphia personal injury attorney as
quickly as possible. The lawsuits for Actemra injuries are increasing
daily because of Genentech and Roche’s failure to warn— your
Philadelphia class action attorney will work hard on your behalf to ensure
your rights and future are fully protected.
To learn more about your legal options or to schedule a free consultation
with an attorney, please call the Philadelphia dangerous drug lawyers
at Golomb & Honik, P.C. today at (2 :L5) 278-4449 or fill out our
The national dangerous drug lawyers at Golomb & Honik, P.C. have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.