Acterma Label, Associated with Hundreds of Deaths. Rheumatoid arthritis, a seriously disabling disorder, impacts approximately 1.5 million Americans. Treatments for the disorder have long been associated with potentially serious side effects.
When Actemra (tocilizumab) reached the United States market in 2010, it was touted as not being tied to heart attacks, heart failure, of life-threatening lung complications as some other rheumatoid arthritis drugs have been, according to STATNews. Meanwhile hundreds of patients taking Actemra have died from these problems with many other patients reporting similar injuries. STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found definitive evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients who taking some competing drugs. Most competing drugs warn about these potential adverse events on their labels; Actemra does not.
Actemra is taken intravenously or by injection and has been used in the treatment of more than 760,000 patients globally, generating sales of $1.7 billion, last year alone. Actemra is Roche’s fifth highest-grossing drug, according to STAT. Although approved for, and primarily used for the treatment of rheumatoid arthritis. Physicians prescribe the drug off-label, or for uses for which a drug is not approved, for some 60 other conditions. Rheumatoid arthritis is an autoimmune disease that leads to pain, swelling, and stiffness in joints and differs from common osteoarthritis, which is more common and, typically, a disease of old age.
STAT’s investigation revealed that patient risk might be at greater risks than patients realize. The U.S. Food and Drug Administration (FDA) received 1,128 reports of individuals who died following treatment with Actemra. The agency reviewed the drug safety several times since its approval, according to STAT.
In one example, obtained through the Freedom of Information Act, a physician indicated that no factor, other than use of Actemra, explained a fatal brain bleed suffered by 73-year-old man. He was given Actemra intravenously two days prior. Another case involved a 62-year-old woman’s heart attack in 2014. “The company assessed fatal myocardial infarction as related to (Actemra).” Neither Roche nor the FDA has made an attempt to change Actemra’s label to alert patients and doctors that potential risks turned up in the reports and clinical studies completed after the medication was released to the market, according to STAT.
According to a transcript of an Actemra meeting, Dr. David Felson, a Boston University rheumatologist, described patient blood test data revealing increased levels of the blood lipids cholesterol and triglyceride, suggesting that Actemra might be responsible for serious heart problems. Dr. Felson and every other scientific adviser ultimately recommended approval, on one condition, that Roche sponsor a multi-year study to review for unobserved problems and cardiovascular events. Meanwhile, there will be no mention of these possible hazards on Actemra’s label, which is what physicians and patients use to consider a drug’s risk-benefit profile. In a recent interview, Dr. Felson described STAT’s findings as “noteworthy and concerning.” As for assertions that Actemra’s cardiovascular safety had been proved “sounds like a drug company trying to defend themselves…. I just want it straight’
In an injury case, a woman, 40, said her physician told her that Actemra had minimal side effects when prescribing it to her for rheumatoid arthritis. She said she suffered heart palpitations for days immediately after her first Actemra infusion. This symptom is often reported by other patients and in complaints to the FDA and does not appear on Actemra’s warning label. When the woman sought help, her rheumatologist told her he had not heard of this side effect and referred her to her general practitioner. “When I went to the [general] doctor, they offered me an antidepressant, but I said I’m not anxious,” she told STAT. “If you give them a symptom they don’t know, they treat you like you’re a little crazy … I felt like I was dismissed.”
A 25-year-old woman said that, after starting Actemra, she experienced what she described as “brain fog,” adding that, “I’ve had moments where I’ve gone to start my car … and not remembered how to turn it on.” She said that, at other times, she has forgotten how to put on makeup. These cognitive side effects are not listed on the drug’s label but are a common complaint among Actemra users. “It’s terrifying with a drug when you come to the realization that you haven’t been warned by your doctors,” she said. “It kind of ruins your life.”
Patients described other unlabeled side effects in interviews and reports to the FDA, including the heart-rhythm disorder, tachycardia; small strokes; and tremors. “I don’t want any sugar coating-I just want it straight,” said a 53-year-old woman. She suffered from another unlabeled, yet commonly reported, side affect- hair loss. “Why would you use something that would do that when there are 15 other drugs to try? That was really depressing,” she told STAT. “[Actemra] has been a miracle for some people. But I think that on the whole, more people have serious side effects.”
Parker Waichman LLP has years of experience representing clients in lawsuits alleging injuries associated with medications. The firm continues to offer free legal consultations to anyone with questions about filing an Actemra defects lawsuit.
Despite Adverse Events Tied To Actemra, Drug Remains on the Market
STAT indicated that experts who reviewed its data said that federal regulators should consider including warnings for heart failure and pancreatitis immediately. Pancreatitis is an inflammation of the pancreas. When acute, pancreatitis may kill up to 50 percent of patients. The expert also said that evidence that Actemra may increase risks of heart attacks, strokes, and interstitial lung disease-a sometimes-fatal scarring of lung tissue-warrants additional review.
“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,” said Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University. “The system is broken, and all the financial incentives are lined up to keep it broken,” STAT reported. In 2015, the Government Accountability Office (GAO) reported that the “FDA lacks reliable, readily accessible data” needed for methodical management and to ensure drug makers remain compliant with agreements to track safety after a drug comes to market.
Actemra might not be more dangerous than other arthritis drugs on the market and, many of those are known to be associated with lethal side effects; however, according to STAT, patients and doctors are misled into thinking that Actemra might be safer because frequently reported, serious problems are not indicated on its warning label.
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