Rheumatoid arthritis is a disabling disease afflicting approximately 1.5 million Americans. When Actemra reached the market in 2010, doctors and patients were excited for the new drug that helped the disease, but was not associated with heart attacks, heart failure, or life-threatening lung issues unlike competing drugs.
However, hundreds of patients taking Actemra have died from just such problems, and many more have suffered harm. Over 500,000 side-effect reports on rheumatoid arthritis medication were analyzed and proof was found that the risks of heart attacks, strokes, heart failure, and other conditions were high or higher for Actemra patients than for those taking competing drugs. Most of those medication have warnings on their labels about these risks, while Actemra does not, reports STAT News.
Side Effect Concerns
Drug ads are accompanied by mind-boggling lists of side effects, but the investigation by STAT shows that the risks to patients might be greater than they are led to believe. In 2011, “fatal anaphylaxis” was added to the label, after two deaths occurred. The U.S. Food and Drug Administration (FDA) has received reports on 1,128 people who died after taking Actemra, and has analyzed its safety several times since its approval. However, the FDA does not have adequate tools to determine whether Actemra was to blame or a “bystander” in those deaths.
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Although the FDA is responsible for monitoring the safety of prescription drugs, it does not verify the side effect reports it receives and the documents often lack crucial information. In one example, obtained through the Freedom of Information Act, a doctor said that an intravenous Actemra treatment was the only explanation for a 73-year-old man’s fatal brain bleed two days following the treatment. In another case, a 62-year-old German woman had a heart attack in 2014. “The company assessed fatal myocardial infarction as related to (Actemra).” Actemra’s manufacturer, Roche, was that company, STAT News reports.
Failure to Warn on Label
However, neither the FDA nor Roche has done anything to change Actemra’s label to warn patients and doctors of potential risks that emerged in reports, along with clinical studies completed after the drug was put on the market. The failure to warn consumers, experts say, shows the FDA’s inadequacy in scrutinizing the safety of drugs subsequent to their approval, and to act promptly when potential hazard signs appear.
Experts who examined the data said the FDA should immediately consider warnings for heart failure and pancreatitis, an inflammation of the pancreas that in its acute form can kill up to 50 percent of patients. The evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease, a sometimes-fatal lung tissue scarring, is not as convincing, but deserves further investigation.
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 system is broken, and all the financial incentives are lined up to keep it broken.”
Since 2009, the FDA has spent $207 million to build a big-data system called Sentinel that searches insurance company records for serious side effects of recently approved drugs. Critics say, among its shortcoming, it is missing most data on deaths related to prescription drugs. It is not known if a Sentinel assessment of Actemra has ever been done, according to STAT News.
Vioxx Removal from Market
Another arthritis drug, Vioxx, had been removed from the market after it was implicated in tens of thousands of heart attack fatalities, an issue that had not appeared in the short-term clinical trials used for approval. Those initial studies suggested Vioxx would be safer than existing medications. Actemra seemed relatively safe based on short-term studies.
Dr. David Felson, a Boston University rheumatologist voiced his concern about the safety of Actemra. He described patient blood test data showing elevated levels of the blood lipids cholesterol and triglyceride, suggesting that Actemra might over time, cause serious heart problems.
In one study, required by the FDA, Actemra was compared with another arthritis drug, Enbrel, whose label strongly cautions about use by patients with cardiovascular disease, particularly heart failure, STAT News reports.
In May, the FDA approved Actemra to treat giant cell arteritis, an inflammation of the blood vessels, that like rheumatoid arthritis, is an autoimmune disease. It based the decision on a one-year study by Genentech that involved only 149 patients who took the drug. The FDA said in a press release that the trial’s “overall safety profile.. was generally consistent with the known safety profile of Actemra.”
Legal Help Regarding Arthritis Medications’ Side Effects
If you or someone you know has been injured by Atemra or other arthritis medications, you may be eligible for valuable compensation. The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).