According to STAT, a national publication focused on health, medicine, and scientific discovery, hundreds of patients taking the arthritis medication Actemra have died from heart complications but patients and their doctors say they were not warned of cardiac risks.
Parker Waichman LLP has represented individuals in scores of drug-injury cases and can answer questions about a possible Actemra lawsuit.
Arthritis Medication Poses Serious Cardiac Risks
When Actemra (tocilizumab), a new medication for rheumatoid arthritis came to market, it was hailed as a breakthrough that would “transform expectations” for patients and doctors. Actemra, administered intravenously or by injection, has been used by more than 760,000 patients globally. The drug generated sales of $1.7 billion in 2016.
Rheumatoid arthritis is a chronic inflammatory disorder that can affect not just the joints but body systems including the skin, eyes, lungs, heart and blood vessels, the Mayo Clinic explains.
Rheumatoid arthritis affects about 1.5 million Americans, and the treatments can have serious side effects. When Actemra came to market in 2010, the drug was not associated with heart attacks, heart failure, or life-threatening lung complications. But, STAT reports, 500,000 side-effect reports on rheumatoid arthritis drugs showed clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients as for those taking competing drugs. Most of the other medications warn about these risks on their labels, but Actemra does not.
FDA Repeatedly Reviewed Actemra
The U.S. Food and Drug Administration (FDA) has received reports of 1,128 people who died after taking Actemra. and has reviewed its safety several times since it was approved. But the agency does not have the sophisticated tools to determine whether the drug was responsible for those deaths. Though the FDA is charged with monitoring the safety of prescription drugs, it does not verify side-effect reports. These reports often lack crucial information, and did not prove that Actemra was the cause of death.
But the reports did show reason for concern. In a report obtained through the Freedom of Information Act, a doctor said nothing other than the drug could explain a 73-year-old man’s fatal brain bleed two days after an intravenous Actemra treatment. The report of a 62-year-old German woman’s 2014 heart attack said, “The company [Roche] assessed fatal myocardial infarction as related to (Actemra).” Roche manufactures Actemra.
But STAT reports that neither Roche nor the FDA has moved to change Actemra’s label to warn patients and doctors of the risks that showed up in adverse event reports and in clinical studies completed after Actemra went on the market.
Experts who examined the data at STAT’s request felt the FDA should immediately consider requiring warnings for heart failure and pancreatitis. Acute pancreatitis can kill up to 50 percent of patients. Though evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease is less convincing, the experts said it warrants further review.
The failure to warn of Actemra’s risks, experts say, points to the FDA’s inability to adequately monitor the safety of drugs after they have been approved, and to act quickly when there are danger signs.
Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University, said, “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective.”
The FDA has been trying to strengthen its monitoring of drugs once they reach the market and are in wide use in diverse populations. In 2015 the Government Accountability Office said the FDA “lacks reliable, readily accessible data” needed for systematic oversight. The FDA has spent $207 million to build the Sentinel system, which scours insurance company records for serious side effects of recently approved drugs. But critics Sentinel is missing most data on deaths related to prescription drugs. The FDA would not say if a Sentinel assessment of Actemra has ever been undertaken, STAT reports.
There is a tension between calls to speed up drug approvals and the need to monitor drugs once they have reached the market. The recently passed 21st Century Cures Act streamlines pre-approval reviews of safety and efficacy. But critics say there needs to be strong oversight over drugs when they reach the market to catch any missed safety problems.
In 2008, when FDA scientific advisers met to consider whether to recommend approval of Actemra, they were mindful of the recent debacle with the arthritis drug Vioxx. Vioxx was pulled from the market after it was linked to tens of thousands of heart attack deaths, a problem that had not shown up in the short-term clinical trials used for in the approval process. The early studies suggested Vioxx would be safer for patients than existing medicines. Actemra also seemed relatively safe based on short-term studies.
At that meeting, Dr. David Felson, a Boston University rheumatologist, worried that “in five years there’s another hearing like the one on Vioxx, where the cardiologists … say to us, what were you guys thinking when you approved this drug?” Felson noted blood test data showing elevated levels of cholesterol and triglycerides, suggesting that Actemra might cause serious heart problems over time, according to STAT.
The scientific panel recommended Actemra approval on condition that Roche would sponsor multiyear studies to monitor side effects and cardiovascular events in patients taking Actemra. But Roche was not required to include potential heart risks on the Actemra label. Label warnings provide key information for doctors and patients weighing a drug’s risks and benefits.
Actemra might not be more dangerous than other arthritis drugs, STAT notes, but the omission of a heart warning may have misled patients and doctors into believing that Actemra was safer than the drugs that carried heart warnings on their labels. Reports to the FDA describe other unlabeled adverse events, including tachycardia (a heart-rhythm disorder), small strokes, and tremors.
Help for Those Harmed by Actemra
If you or someone you know who has taken Actemra considered a defective drug has suffered a heart attack or other cardiac side effects, Parker Waichman LLP can advise you about your legal right. For a free, no-obligation case evaluation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).