The rheumatoid arthritis (RA) medication Actemra – which is a brand-prescription
for the medication called tocilizumab – has been linked by recent
studies to serious and potentially fatal side effects when taken by users
of all age groups. The publication group STAT conducted the study by pouring
over more than half a million reports regarding RA drug side effects and
ultimately concluded that Actemra might have been the cause of at least
100 patient deaths. The investigation determined that people using Actemra
had a higher chance of suffering certain health issues that those using
Actemra users were more likely to experience:
• Heart attacks
• Cardiac arrest
• Lung disease
• Permanent hair loss
• Several other life-threatening conditions
Within all of the patient health reports studied by STAT, more than 1,100
Actemra user deaths had been reported to the Food and Drug Administration
(FDA) for cataloguing. Researchers were also surprised to find that Actemra’s
warning labels had no language that discussed the most serious potential
side effects of the drug. It is worth noting that competing RA drugs do
have a warning label with a complete list of potential health consequences.
Who Manufacturers Actemra?
When a prescription drug is found to be unreasonably dangerous for patient
use, the party that is most likely to be found liable for the damages
is the drug’s manufacturer. In Actemra’s case, this company
is Genentech, which belongs to the Roche Group. The drug was first sent
to markets in 2010 to help alleviate the symptoms of several forms of
arthritis and other conditions, including giant cell arteritis. Actemra
was manufactured to be administered as both an injectable and an intravenous
STAT researchers found that Actemra sales raked in nearly $2 billion for
Genentech in 2016 alone. The company also reported that more than 750,000
people the world over were either active users of Actemra or had been
recently. People who are currently using Actemra but experiencing potential
side effects should consult with their trusted physicians as soon as possible.
You should not stop using any prescription medicine without first obtaining
your doctor’s approval.
Actemra Risks Compared to Similar Drugs
The number one serious side effect of Actemra, as noted in the STAT research
study was heart attack, which was reported in a total of 410 cases. At
first, researchers were thrown by the fact that the RA drugs Remicade
and Humira both had more total reports of side effects during the study
period (2010 to 2016). It was later concluded that the higher incident
of Remicade and Humira side effects could be explained by the fact that
both of the competing RA drugs had more total users and that those users
were clearly warned of risks; without knowing the risks associated with
Actemra due to inadequate packaging, users would be less likely to identify
related issues and tell their doctors about them.
Will the FDA Recall or Black Label Actemra?
In circumstances when a prescription drug has been definitively linked
to dangerous health side effects, the FDA may actually demand a recall
of the medication. However, this action is quite rare. The more likely
scenario is the FDA requiring the drug to be “black labeled,”
which is to say a large black warning label listing the most serious of
side effects must be added to the packaging.
At this time, the FDA has not taken any additional steps to warn consumers
and physicians alike of the apparent dangers of Actemra. There has been
no recall and no mandatory black label addition. The FDA has not even
required Actemra to update its labels to include the same warnings as
similar drugs. Currently, Actemra’s warnings only mention bacterial
infection risk and a few other different types of infection.
Holding Genentech Accountable for Actemra Injuries
Any drug manufacturer and pharmaceutical corporation has an inalienable
obligation to make products that are as safe as possible and to warn patients,
doctors, and other consumers if there are potential side effects. Without
full knowledge of the risks compared to the advantages of the drug, people
cannot actually come to a sound decision regarding whether or not the
drug should be used or prescribed. The failure to meet this duty is grounds
for a lawsuit filed by injured parties who can cite the company’s
At Brett H. Oppenheimer, PLLC, our Louisville product liability and personal
injury attorneys have the experience, tenacity, and know-how required
to take on large pharmaceutical corporations, such as Genentech, with
confidence. If you or a loved one were hurt by a dangerous prescription
drug like Actemra, contact Attorney Oppenheimer today to discuss your
rights, options, and potential compensation. Free consultations are available.