Actemra (tocilizumab) is a prescription medication used to treat rheumatoid arthritis (RA) and may be linked to life-threatening side effects that are not indicated on its labeling.
As an autoimmune disease, rheumatoid arthritis both attacks and causes damage to the joints. It affects roughly 1.5 million Americans, primarily women. It is incredibly difficult for doctors to treat without putting the patient at risk of other complications.
Actemra is a monoclonal antibody drug that was developed by Genentech and hit the US market in 2010. It is prescribed for those who have moderately to severely active rheumatoid arthritis. Additionally, it is used for adult patients with giant cell arteritis (GCA).
Actemra can be administered as a 60-minute single IV drip infusion that increases in quantity over time, or a self-administered subcutaneous administration.
Patients have been prescribed Actemra when other disease-modifying anti-rheumatic drugs (DMARDs) fail to work. But according to a handful of studies, the side effects of Actemra have proven little difference compared to competing medications on the market.
In 2018, the US Food and Drug Administration approved Actemra for use in juvenile populations. Specifically, those with polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA) are now able to be administered Actemra as early as two years old.
With the release of the subcutaneous form of Actemra and uses in the juvenile population, sales were up by 12% in all regions of the United States in 2018, as well as internationally.
Actemra hailed as a ‘breakthrough’ medication for RA – study shows otherwise
Other drugs used to treat rheumatoid arthritis (Humira, Remicade or Enbrel) have been known to cause debilitating side effects such as cardiovascular issues, pancreatitis and interstitial lung disease.
When Actemra came onto the market, it was hailed as a breakthrough medication because its manufacturer claimed it did not cause any of the above mentioned side effects. The hype has been widely successful for Roche Pharmaceuticals, generating sales of $1.7 billion in 2016 alone.
According to a recent study published in STAT, Actemra may have been the cause of hundreds of deaths. An investigative piece conducted by Advera Health for STAT looked at rheumatoid arthritis medications from 2010 to 2016 and information gathered in the FDA Adverse Event Reporting System (FAERS).
The study reviewed more than 500,000 side effects reports of rheumatoid arthritis medications. The investigation concluded the potential fatal side effects of Actemra may be just as high, if not higher, than other RA medications on the market.
The results indicated 1,128 deaths have been reported to the FDA that were directly associated with Actemra. Though the FDA monitors the medications for approval on the market, it does not monitor the side effects with the same scrutiny. Therefore, the agency has been unable to pinpoint Actemra as the independent variable to causing life-threatening complications.
The common side effects linked to Actemra, but are not on its label, are heart attack, stroke, heart failure, interstitial lung disease and pancreatitis. In addition, tremors, tachycardia and hair loss are other side effects associated with it as well.
- Pancreatitis is an inflammation of the pancreas that can kill up to 50 percent of those diagnosed.
- Interstitial lung disease is a scarring of the lung tissue and can be fatal.
- One study showed that the rate of heart failure and stroke with Actemra was 1.5 times higher than Enbrel (Etanercept). The problem with Actemra is not the side effects, it’s the lack of accountability from the manufacturer to list their potential.
According to STAT, through a report it obtained through the Freedom of Information Act, a 73-year-old man experienced fatal brain bleeding two days after IV-treatment of Actemra. His doctor could not explain any factor, other than Actemra, that contributed to his patient’s death.
A 62-year-old woman suffered a heart attack in 2014 and “the company assessed fatal myocardial infarction as related to (Actemra).” The referenced company is Roche– the manufacturer of Actemra.
Despite these findings, Actemra has yet to experience a label change that indicates these potential fatal side effects and is putting thousands of patients at risk of injury.
The FDA often approves drugs to enter the market that are based on preliminary evidence. Yet post-marketing assessment to determine long-term risks underperforms within the agency. The adverse reports submitted to the FDA are only voluntarily reported, meaning more patients could be experiencing the side effects of Actemra and the statistics are not there to indicate the intensity.
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