Actemra Risks Of Heart Failure And Other Serious Side Effects. Parker Waichman LLP is investigating potential lawsuits on behalf of individuals who have taken the rheumatoid arthritis medication, Actemra (tocilizumab), and who have suffered heart failure, a heart attack, pancreatitis, or other side effects.
Plaintiffs nationwide are filing lawsuits against drug makers Roche and Genentech for failing to warn to warn the medical community and the public about serious risks associated with Actemra.
Parker Waichman has successfully represented people who have been injured by widely prescribed drugs including drugs to treat the pain and inflammation of rheumatoid arthritis.
Serious Complications Associated with Actemra
Patients and their doctors allege that Actemra puts patients at risk for heart attack, heart failure, stroke, pancreatitis, lung disease, gastrointestinal perforation, and death. There have been 1,128 death reports to the U.S. Food and Drug Administration (FDA) involving patients taking Actemra.
Prescription drugs with dangerous or even deadly side effects sometimes reach the market without adequate testing. Patients are often injured or die before the FDA determines that the drug has side effects that may far outweigh whatever benefits the drug maker has claimed.
A recent article in STAT, a national publication on health, medicine, and scientific discovery, reported on hundreds of people taking Actemra who have died from heart attacks, stroke, heart failure, and lung complications. Life-threatening complications are occurring at the same frequency with Actemra as they are with other rheumatoid arthritis medications. The difference, STAT says, is that other drug makers warn of the risks but Roche and Genentech do not.
According to the Arthritis Association, rheumatoid arthritis is an autoimmune disease in which the body’s immune system, which is meant to protect the by attacking foreign substances such as bacteria and viruses, attacks the joints in error. This leads to inflammation that causes the tissue that lines the inside of joints, known as the synovium, to become thick. This leads to swelling and pain in and around the joints. The synovium manufactures a fluid that lubricates joints and helps them move more smoothly.
Should the inflammation go untreated, cartilage may become damaged, as may the elastic tissue that covers the ends of bones in a joint and the bones themselves. Over time, the patient may experience the loss of cartilage and the joint spacing between bones may become smaller. Joints may become loose, unstable, painful, and lose their mobility; joint deformity may also occur. Joint damage is irreversible. Physicians recommend early diagnosis and aggressive treatment to control RA.
Rheumatoid arthritis typically affects the joints of the hands, feet, wrists, elbows, knees, and ankles and joint effect is generally symmetrical. If one knee or hand is affected, the other one is usually affected, as well. Because RA also may affect body systems such as the cardiovascular or respiratory systems, it is described as a systemic (entire body) disease.
Rheumatoid arthritis may also damage a number of different of body systems, including skin, eyes, lungs, heart, and blood vessels and severe rheumatoid arthritis may cause physical disabilities, according to the Mayo Clinic.
Rheumatoid arthritis affects about 1.5 million Americans.
What is Actemra?
Actemra was approved by the FDA in 2010 to treat rheumatoid arthritis and was later approved to treat giant cell arteritis, which is an inflammation of the lining of the arteries—most often the arteries in the head.
Worldwide, more than three-quarters of a million patients have used Actemra. STAT reports that Actemra is Roche’s fifth highest drug in gross sales, having brought in $1.7 billion in 2016, alone.
The Genentech website lists the most common Actemra side effects as:
- upper respiratory tract infections (common cold, sinus infections)
- increased blood pressure
- injection site reactions
- hepatitis B infection in people who already carry the virus
- serious allergic reactions
- nervous system problems such as multiple sclerosis
But STAT’s review found that hundreds of people taking Actemra have died. STAT has urged the FDA to direct changes to the Actemra label to warn of serious health risks including:
- heart failure
- heart attack
- interstitial lung disease
Interstitial lung disease causes scarring of the lungs, which may affect breathing. The scarring is irreversible, according to the Mayo Clinic.
Actemra vs. Other Arthritis Medications
STAT conducted a head-to-head comparison of rheumatoid arthritis medications and found that patients taking Actemra were 50 percent more likely to have a heart attack or stroke than patients taking Enbrel (etanercept). Pfizer, which makes Enbrel, warns of potential heart problems, while Roche does not.
STAT reported the same number of interstitial lung disease incidents in patients taking Actemra vs. those taking Humira, and more occurrences than in patients who took Remicade. Humira and Remicade are competing drugs whose manufacturers warn of these risks, while Actemra does not.
When Actemra was introduced to the U.S. market in 2010, doctors and patients were encouraged to learn that the drug was not associated with these serious side effects. But a review of 500,000 patients taking Actemra indicates that Actemra does in fact carry the same serious risks. STAT reports that heart- and lung-related side effects are “as high or higher for Actemra patients than for patients taking some competing drugs.” In one case, a physician noted “no factor other than the drug could explain it” after the death of a 73-year-old man by brain hemorrhage two days after receiving Actemra intravenously.
FDA Urged to Order Heart Warnings for Actemra
Experts who reviewed the STAT data have urged the FDA to issue warnings about the risk of heart failure and pancreatitis, which may both be fatal; however, the FDA indicated that it lacks the necessary tools to determine whether Actemra is definitively the cause of the 1,128 deaths. Some experts noted “the FDA’s inability to adequately scrutinize the safety of drugs after they have been approved and to act promptly when potential danger signs appear,” according to STAT.
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 [a drug that has] been out there for several years is safe and effective.” Prasad called the drug oversight system “broken,” and he said that “all the financial incentives are lined up to keep it broken.”
In a 2015 Drug Safety Memo, the Government Accountability Office (GAO) wrote that, the “FDA lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and to conduct systematic oversight.” Problems with the completeness, timeliness, and accuracy of the data, as well as problems with accessibility, “have restricted the agency’s ability to perform systematic oversight of post-market drug safety,” the GAO added.
The GAO critique went on to say that the federal regulators do not have plans to determine whether drugs approved through expedited approval programs “were subsequently associated with tracked safety issues at rates or of types that differed from drugs that used FDA’s standard process.”
Help for Those Harmed by
If you or someone you know has taken Actemra and has suffered a heart attack, cardiac arrest, or other side effect, the attorneys at Parker Waichman LLP is available to advise you about your legal rights. For a free, no-obligation case evaluation, please fill out the online contact form or call us toll-free at 1-800-YOURLAWYER (1-800-968-7529).
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