Roche’s Actemra was heralded as a breakthrough therapy for rheumatoid arthritis when it was introduced in 2010.
The drug’s website proclaims that “Actemra works differently” and shows a patient happily scuba diving and walking on a tropical beach. But nowhere does Roche mention certain side effects that may have contributed to more than 1,100 patient deaths.
More than 1,100 Actemra patients died after taking the drug. Roche may face lawsuits over failure to warn.
Research suggests that Actemra patients, compared to those taking competing rheumatoid arthritis drugs, face similar risks for heart attacks, heart failure, strokes, lung disease, and pancreatitis. But unlike the competition, Actemra’s label does not warn about these side effects.
ClassAction.com’s attorneys are investigating Actemra safety claims. If you or a loved one suffered heart, lung, or pancreatic side effects while taking the drug, please contact us for a free case review.
Actemra Heart and Lung Side Effects
A STAT News report and postmarketing studies raise questions about the adequacy of Actemra’s safety warnings.
STAT reviewed more than 500,000 adverse event reports on leading rheumatoid arthritis drugs, including Actemra, Humira, and Remicade. STAT found evidence that Roche downplayed Actemra’s cardiovascular, pancreatic, and lung side effects.
According to STAT, from 2010 to 2016 the U.S. Food and Drug Administration (FDA) logged more than 13,500 Actemra adverse event reports, including 1,128 patients who died after taking Actemra.
While safety data indicate the risks of heart attacks, strokes, heart failure, and interstitial lung disease are as high or higher for Actemra patients than for patients taking some similar drugs, Actemra’s warning label—unlike its competition’s—does not reflect these risks.
Doctors and patients may not get a complete picture of Actemra’s risk-benefit profile.
For example, Actemra patients reported more cases of interstitial lung disease than Remicade patients, and nearly the same number as Humira patients. But while Remicade and Humira have interstitial lung disease warnings, Actemra does not.
STAT’s findings are supported by postmarketing studies—clinical studies conducted after a pharmaceutical product goes on the market to better understand drug risks.
The FDA ordered Actemra postmarketing studies because premarket testing revealed potentially worrisome side effects. One such study compared Actemra to another arthritis drug, Enbrel, and found rates of stroke and heart failure were about 1.5 times higher in Actemra users. Enbrel has strong warnings for patients with cardiovascular disease. Actemra does not have similar warnings despite similar or worse cardiovascular risks.
The takeaway from these findings is that doctors and patients may not be getting a complete picture of Actemra’s risk-benefit profile.
Drug Manufacturers Have a Duty to Warn
Pharmaceutical products are not expected to be completely without harmful side effects. But if a drugmaker understands that a drug presents a certain risk, it has a duty to put an appropriate warning label on the product. That way patients and their doctors can evaluate all known risks and benefits and make an educated decision about whether a medication is right for them.
While the FDA has authority to demand warning labels, the responsibility ultimately falls on drug manufacturers. Actemra has garnered FDA attention since it was approved in 2010. At one point the agency considered a pancreatitis warning label. But Genetech/Roche talked the FDA out of the warning. The agency then approved broader use of Actemra for giant cell arteritis.
The drug safety system can’t always be trusted to put patient safety first, so patients often must turn to the legal system.
Conflicts of interest between manufacturers and regulators plague the drug safety system. The STAT report details how all 11 authors of an Actemra postmarketing study had financial ties to Roche or Genetech. And a former FDA manager who oversaw Actemra’s approval for rheumatoid arthritis now works for Roche, where he helps gain FDA approval for new uses of the drug.
The drug safety system, in other words, cannot always be trusted to put patient safety first. That’s why, when patients suffer harm from drug side effects, they often must turn to the legal system.
Actemra Lawsuit Eligibility
ClassAction.com is looking into claims that Genetech/Roche failed to warn about the following Actemra side effects:
- Heart attack
- Heart failure
- Interstitial lung disease (lung tissue scarring)
Actemra patients who suffered any of these side effects may be eligible for a lawsuit.
Product liability lawsuits typically provide victim compensation for losses that include:
- Past and ongoing medical expenses
- Past and future lost wages
- Pain and suffering
- Diminished quality of life
- Losses related to the death of a loved one, such as funeral expenses
The actual damages a plaintiff is entitled to depend on the extent of their losses and other individual circumstances.
ClassAction.com Investigating Actemra Claims
While Actemra can help to alleviate the debilitating effects of rheumatoid arthritis, questions remain about the drug’s safety.
ClassAction.com’s team of attorneys has taken on some of the biggest, most powerful companies in the world—including drug companies—and won billions of dollars for our many clients. We have the experience and resources to tackle complex pharmaceutical litigation, and are currently investigating Actemra lawsuits.
If you or a loved one took Actemra and suffered a heart attack, heart failure, stroke, pancreatitis, or lung complications, our attorneys want to hear your story.
You have the power to hold drug companies accountable: please contact us today for a free, no-obligation case review.