This is a demographic that remains active and will not allow something like rheumatoid arthritis to slow them down. They will gladly accept a medication such as Actemra for promised relief and the opportunity to get on with their day, and their lives.
However, according to a respected online investigative publication associated with Boston Globe Media, Actemra patients appear to be losing their lives in strikingly large numbers, with reports of Actemra linked to heart attacks and deaths.
What’s more, the drug has only been around for seven years. However, STAT (06/05/17) reports that there are in excess of 1,000 deaths that may be associated in some way – if not conclusively caused – through use of Actemra.
From a legal perspective, this could easily be the next big sleeper of a mass tort.
Actemra (tocilizumab) was approved by the US Food and Drug Administration (FDA) in 2010. Two years earlier, when FDA expert panels met to discuss the merits of approving Actemra, one rheumatologist worried about clinical trial data that showed trial participants presented with elevated levels of cholesterol and triglycerides, leaving the Boston-based doctor with concerns that tocilizumab could actually cause serious heart problems over time.
And yet, when Actemra was approved and introduced in 2010, marketing materials claimed that unlike competing arthritis meds the injectable or intravenous tocilizumab was not associated with heart attacks, heart failure or other life-threatening lung complications. It should be noted, according to STAT, that Actemra was recommended for approval even by the naysayers at the 2008 FDA meeting, on condition that manufacturer Genentech, a division of the Roche Group, would sponsor multiyear studies to monitor for cardiovascular events and other unforeseen issues. In the meantime, those stated concerns for potential cardiovascular events raised at the meeting – together with the requirement for post market studies – were not referenced anywhere on the medication’s prescribing information, according to STAT.
Fast forward to today. The FDA is in receipt of reports that over the last seven years Actemra has been on the market no fewer than 1,128 people have died after taking Actemra. There is as yet no proof that Actemra had a causal association to those deaths, but the potential for an association remains. What’s more, the above-noted figure represents actual deaths, but does not include the scores of individuals who have reported close calls through Actemra side effects.
And those individuals are not always elderly, either. Actemra patient Alejandra Calzadillas reported that she experienced memory lapses and mental fogginess after beginning treatment with Actemra. Calzadillas is 25 years old.
Alicia Airs, who calls Youngstown Ohio home, suffers from rheumatoid arthritis and said in comments published in STAT that her doctor suggested Actemra carried minimal tocilizumab side effects. However, Airs reports heart palpitations for days following her first infusion with Actemra.
Airs is 40 years old.
Over a thousand deaths in 7 years potentially associated with Actemra have forced the FDA to continue holding tocilizumab side effects under a microscope. And again, there is no conclusive evidence that suggests Actemra is the root cause of these deaths. But there are sufficient examples to warrant suspicion of a potential association. STAT obtained adverse event reports through a Freedom of Information Act filing and discovered one man, age 73, died from a brain hemorrhage two days after an infusion with Actemra. The man’s doctor said there was no other factor that could have caused, or explained his patient’s fatal hemorrhage other than use of tocilizumab.
In another example, according to STAT, a German woman suffered a fatal heart attack at the age of 62 in 2014. The report referenced that “[Genentech] assessed fatal myocardial infarction as related to [Actemra].”
Experts having examined the data obtained by STAT opined that warnings for heart failure and pancreatitis should be considered immediately. However, neither Roche nor the FDA appears to have any immediate plans to do that.
Some 1.5 million Americans are afflicted with rheumatoid arthritis, for which Actemra is primarily indicated. However, STAT reports that Actemra has been prescribed off-label for some 60 related conditions for which tocilizumab does not carry FDA approval. And that’s both perfectly legal and medically ethical, given that doctors – by way of their medical qualifications and intimate knowledge of both their patient and the medication(s) they are considering – have the authority to make such a judgment call.
However without inclusion of the potential for pancreatitis, or Actemra linked to heart attacks and deaths on the tocilizumab prescribing information, doctors are somewhat in the dark.
STAT reported that Roche Genentech earned $1.7 Billion in sales form Actemra in 2016.
Given the number of reported deaths, and the prevalence of rheumatoid arthritis amongst an aging American population, legal experts expect a flood of Actemra lawsuits once this sleeping issue awakens…