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A new report by STAT News has raised new concerns about the rheumatoid arthritis (RA) drug Actemra and its link to serious cardiac injuries. In 2010, manufacturers Roche and subsidiary Genentech released Actemra for sale in the U.S. In their marketing, they touted the drug as being a “new” type of medication that helps relieve symptoms without causing as many potential side effects as other similar drugs.

The new report, however, indicates that the drug may be just as risky, if not more so, than other similar RA drugs. Whether the Food and Drug Administration (FDA) will conduct additional investigations on the safety of this drug remains to be seen.

Actemra Comes Onto the Market as a “New” Option

Actemra (tocilizumab) is an immunosuppressive drug. Similar to Humira and other RA drugs, it acts to block part of the immune system to help reduce symptoms of swelling, inflammation, and pain. It is different, however, in how it works in the body.

A number of other popular RA drugs block the action of tumor necrosis factor-alpha (TNF-a), a protein involved in the inflammatory process. Actemra targets interleukin-6 (IL-6), another protein that plays a role in the immune response that causes inflammation. People with RA have abnormally high IL-6 levels. Actemra binds to the IL-6 cell receptors to prevent IL-6 from exerting its pro-inflammatory effects.

When it came onto the market in 2010, Actemra was the first drug of its kind to block the activity of this protein. The manufacturers positioned it as being a “new-generation” treatment for RA. In a press release, Genentech stated that Actemra provided “a new option for patients with this very serious disease.”

The clinical trials used to gain FDA approval of the drug showed that it significantly lowered the signs and symptoms of RA, when used alone or with other drugs like methotrexate. It was also supposed to be safer than other similar RA drugs because it did not have warnings about heart risks. The new STAT News report, however, suggests that the manufacturers should have done more research on their product the evaluate Actemra’s cardiovascular risks.

New Report Links Over 1,000 Deaths to Actemra

STAT News examined over 500,000 adverse event reports for Actemra that were submitted to the FDA. And found that the FDA had received reports that 1,128 people died after taking the drug.

STAT News explained that the FDA lacks the tools necessary to verify these reports and to determine whether the drug caused each of these deaths. The number of fatalities, however, certainly raises some concerns. For example, STAT News reported that “[e]xperts who examined the data at STAT’s request said the FDA should immediately consider warning for heart failure and pancreatitis” and noted “the evidence that Actemra may increase the risk of heart attacks … warrants further review”.

The reports also found that the rate of Actemra complications involving heart attacks, strokes, and heart failure “were as high or higher for Actemra patients than for patients taking some competing drugs”.

For years, critics, including the Government Accountability Office (GAO), have reported that the FDA needs to do a better job of monitoring drugs safety after a medication is approved and out on the market. A recent study showed that postmarked safety events were common after FDA approval, suggesting a need for better monitoring. And in 2015, GAO reported that the FDA was ill equipped to ensure that postmarked safety issues were properly addressed, stating “FDA lacks reliable, readily available accessible data” needed to ensure that drug companies comply with agreements for drug monitoring after a drug reaches the market.

Meanwhile, patients who have taken Actemra and then suffered serious side effects like heart problems or pancreatitis may be eligible to file a lawsuit in an attempt to recover damages.

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