Each person stricken by rheumatoid arthritis will be affected differently, due to the complexity of the disease. Rheumatoid arthritis is the third most common type of arthritis, following osteoarthritis and gout. Between 1.3 and 1.5 million Americans—and one percent of the global population—are affected by rheumatoid arthritis. There is currently no cure for rheumatoid arthritis, and the specific cause is, as yet, unknown, however, it is known that the disease is an autoimmune disorder.
Symptoms of the disease can be triggered when the antibodies which exist in all human beings attack the synovial joint fluid, resulting in chronic inflammation and pain. Females are three times as likely to develop rheumatoid arthritis as males and generally develop rheumatoid arthritis at a younger age than the “norm”. While the exact cause of rheumatoid arthritis is not known, risk factors include lifestyle (particularly smoking), hormones, environment, and genetics. Because so many more women develop rheumatoid arthritis, some experts believe there is a strong link between the hormonal changes experienced by women and the onset of rheumatoid arthritis.
The specific symptoms of rheumatoid arthritis include:
While new treatments for rheumatoid arthritis are certainly needed, unfortunately, one rheumatoid arthritis treatment may be more dangerous for patients than the disease itself, despite the FDA’s stamp of approval. Actemra made it through the FDA drug approval process seven years ago, despite numerous red flags. Since that time, hundreds of deaths and injuries have been tied to Actemra, yet the drug remains on the market. In fact, despite the fact that thousands—as of 2012, more than 3,500—of adverse event reports have come to the FDA regarding Actemra, the agency has yet to require the manufacturers, Roche and Genentech, to add any warnings to the labeling of Actemra.
One FDA review of the drug found more than 250 cases of pancreatitis (which can be deadly), and 185 cases of interstitial lung disease—a scarring of the lungs which can eventually require a lung transplant. Heart failure is also a known risk for those taking Actemra. Competing prescription medications for rheumatoid arthritis, Remicade, and Humira, both carry warnings regarding heart failure and heart attacks, yet Actemra—which billed itself as the “safer” drug—carries no such warnings despite evidence to the contrary. Genentech called Actemra a “unique” breakthrough which would “transform expectations” for rheumatoid arthritis patients.
STAT analyzed more than 500,000 reports of adverse side-effects experienced by patients taking Actemra, finding clear evidence that heart attack, stroke and heart failure risks were as high or even higher for patients taking Actemra than for those taking Remicade and Humira. To date, the FDA has received reports of more than 1,128 people who died after taking Actemra, however, the agency is unable to determine whether Actemra is the actual culprit in those deaths.
Yet in one case, a doctor asserted that no factor other than Actemra could have explained his patient’s fatal brain bleed just two days after receiving an IV Actemra treatment. Once the STAT data was evaluated by experts, the recommendation was made to the FDA that warnings for heart failure and pancreatitis should be added to Actemra’s labeling, adding that there is also evidence that Actemra could cause stroke, heart attack, and interstitial lung disease.
In another study, Actemra was compared to Enbrel, another rheumatoid arthritis drug. Enbrel’s labeling strongly cautions patients who have a history of cardiovascular disease against using the drug, yet the Actemra—with no warnings—was found to cause stroke and heart failure about 1.5 times more often than Enbrel.
More than 760,000 patients across the globe have taken Actemra both by injection and intravenously. Roche and Genentech generated more than $1.7 billion in Actemra sales in 2016, making it the fifth-highest grossing drug for Roche. Although Actemra is only approved to treat symptoms of rheumatoid arthritis, Actemra is also sometimes prescribed for off-label use for some 60 other conditions—conditions for which Actemra has not been safety-tested.
The bottom line seems to be that while Actemra may or may not be more dangerous than other drugs marketed for rheumatoid arthritis, both doctors and patients have been misled into believing the drug is safer since no warnings are present on Actemra’s labeling. In addition to the more serious Actemra symptoms, some of those taking the drug have claimed to have memory lapses, brain fog, mental sluggishness, small strokes, an increase in cholesterol levels, hair loss, tremors and the heart-rhythm disorder tachycardia after taking Actemra.
It is worth noting that the actual number of adverse effects, including death, among Actemra users, are most likely considerably higher than the number of adverse reports sent to the FDA. Only a small fraction of adverse events related to prescription drugs are reported to the FDA, and since patients and their physicians have no obligation to report to the FDA, by some estimates only about 10 percent of adverse symptoms are ever reported.
If you have been injured by the rheumatoid arthritis drug Actemra, you may be finding it very difficult to deal with your injuries, particularly if they are serious. The lawyers at Martinson & Beason are committed to helping you get through this trying time, and will consistently fight for your rights and your future. We have significant experience helping those who have been harmed by dangerous drugs and understand how alarming it can be for you to see your medical bills related to your Actemra injuries mounting. If you are interested in joining a mass tort case against the manufacturer of Actemra, the Huntsville, Alabama products liability lawyers are experienced negotiators, aggressive litigators, and compassionate to your medical issues. Protect your future by calling Martinson & Beason today.