By Amanda Antell  |  August 9, 2017

Category: Legal News

Actemra intravenous heart failureInjury reports of Actemra heart failure have caused major concern in the medical community, as this popular arthritis medication is prescribed to numerous patients. Actemra heart failure and other injuries allegedly reported are not mentioned on the medication’s warning label.

An analysis conducted by ehealthme of reports submitted to the FDA found reports of congestive heart failure in Actemra patients over the age of 60 who were on the drug for less than one month.

The study noted that the DA has received over 15,000 reports of side effects from Actrema patients. When the report was consolidated on July 22, 2017, it was found that 70 (0.44%) patients had reportedly suffered from Actemra heart failure.

Actemra is popularly prescribed to patients with rheumatoid arthritis, and is typically given through injection or infusion. When released by the FDA in 2010, the drug was marketed as a unique breakthrough for rheumatoid arthritis patients.

This medication was considered unique in that it supposedly did not present a significant risk of dangerous side effects like heart attacks, cardiac failure, and respiratory complications. Manufacturing company Roche Holding AG had reportedly focused on the drug’s lack of serious side effects when marketing the drug.

Overview of Actemra Complications

However, according to a report by STAT, there have been over 1,100 reports submitted to the FDA of patients who died while taking Actemra. STAT investigators had reportedly analyzed over 500,000 reports of side effects of different rheumatoid arthritis drugs, including over 13,500 Actemra injury reports.

In addition hundreds of those fatalities were reportedly due to Actemra heart failure, or other serious side effects not mentioned on the warning label like pancreatitis.

Furthermore, investigators had found “clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.”

The FDA has investigated Actemra several times since its approval in 2010, with an August 2012 review finding 118 deaths with 42 deaths being related to cardiac complications. Another review conducted had found 258 reports of alleged Actemra pancreatitis and 185 reports of Actemra interstitial lung disease in clinical trials.

Even with these reviews, the FDA did not issue an order to update the Actemra warning label. It is important to note that there were concerns surrounding Actemra side effects even before its release, with a report published in the Wall Street Journal.

This report stated that Actemra had been linked to 15 deaths in Japan, from a study consisting of 5,000 Actemra patients. According to spokesperson for Chugai Pharmaceutical, partially owned by Roche, the study showed a potential “causal relationship” between Actemra and fatalities.

Since the time of its release, over 760,000 rheumatoid arthritis patients have been prescribed Actemra. This medication has also been used to treat 60 other medical conditions for off label purposes, which means the risk of Actemra complications may also be present in non rheumatoid arthritis patients.

 

In general, Actemra lawsuits are filed individually by each plaintiff and are not class actions.

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