Actemra RA Medicine Serious Side Effects. Actemra is used in the treatment of rheumatoid arthritis (RA) and has been linked to serious side effects including cardiovascular and pulmonary disease, pancreatitis, and gastrointestinal perforation. The U.S. Food and Drug Administration (FDA) approved Actemra in January 2010 and then in May 2017, approved it to treat Giant Cell Arteritis (GCA).
Worldwide, Actemra has been prescribed to more than 760,000 RA patients. There have been 1,128 deaths reportedly linked to Actemra. A recent article in STAT News said that hundreds of people taking Actemra who have died from heart failure, heart attacks, stroke, and lung complications show that life-threatening complications happen with the same frequency with Actemra as with other rheumatoid arthritis drugs. The difference is that competing drugs warn consumers and the medical community of side effect risks of Actemra, while manufacturer Roche/Genentech does not.
What is Actemra?
Actemra is a humanized interleukin (IL-6) receptor antagonist approved for use in adults with moderate to severe rheumatoid arthritis. Actemra is Roche’s fifth highest product in gross sales and brought in $1.7 billion in revenue in 2016, according to STAT. More than 500,000 side effect reports for RA drugs were investigated by STAT that “found clear evidence” that the risks of the side effects such as heart attack or stroke, “were as high or higher for Actemra patients than for patients taking some competing drugs.”
Jeffrey Siegel, senior medical director for rheumatology products at Roche and its subsidiary Genentech (RHHBY), told STAT that the investigation raised “important questions” and said the company tries hard not to “be complacent, and to fully explore these issues.”
What is Giant Cell Arteritis?
Giant cell arteritis is an inflammation of the lining of the arteries. Most frequently, it affects the arteries in the head, especially in the temples, so it is sometimes called temporal arteritis. It may also affect the neck and arms. Giant cell arteritis often causes headaches, scalp tenderness, jaw pain, fever, fatigue, unintended weight loss, and vision problems. The onset of the condition may feel like the flu. If left untreated, it may lead to stroke, aortic aneurysm, or blindness, according to the Mayo Clinic.
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Comparison to Other RA Drugs
STAT revealed that patients taking Actemra were 50 percent more likely to have a heart attack or stroke than patients taking Embrel, but Embrel has a warning on its product, while Actemra has not. Humira and Remicade, have been associated with interstitial tissue lung disease. This is the name for a large group of diseases that inflame or scar the lungs, making it difficult to breathe. The competing drugs contain warnings, while Actemra opts not to.
In 2008, FDA scientific advisors met to weigh the merits and risks of Actemra and were brought back to the well-publicized debacle years earlier with the arthritis drug, Vioxx. Heart attack risk had not been revealed in short-term clinical trials in the approval process for Vioxx, yet tens of thousands of patients eventually had fatal heart attacks that were associated to the drug.
A Boston University rheumatologist, Dr. David Felson noted that patient blood test data revealed elevated levels of triglyceride and cholesterol, which could lead to serious heart problems for Vioxx patients in the long run.
Appraisal of FDA’s Performance
“Though the agency is charged with monitoring the safety of prescription drugs, it doesn’t verify the side-effect reports it receives. The documents often lack crucial information, and they don’t prove that ‘Actemra’ was the cause,” said STAT in its report, according to PharmaLive. However, several doctor’s reports indicate the drug played a major part in the death of patients who were treated with Actemra.
STAT cites some unnamed experts who examined the analysis and concluded the FDA must consider adding a warning label to Actemra alerting consumers of the risk for heart failure and pancreatitis. The experts cited by STAT noted a failure to warn consumers “highlights 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,” reports PharmaLive.
An oncologist and medical ethicist at the Oregon Health and Science University, Vinay Prasad, told STAT it has become easier to get drugs approved, but the FDA has not been as thorough in performing “post-marketing surveillance” to ensure the safety and efficacy of a new drug. Prasad remarked that the system is broken and “all the financial incentives are lined up to keep it broken.”
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