Unlike other competing rheumatoid arthritis drugs, Actemra’s warning label does not warn against life-threatening conditions such as heart attack, stroke, lung disease, pancreatitis, and more.
However, there have been over 13,500 side-effect reports involving Actemra, according to an investigation by STAT, and between 2010 and 2016, the FDA received thousands of complaints about adverse reactions to Actemra.
In these complaints, Actemra was implicated in 1,100 patient deaths. The cause of death listed in the majority of these FDA reports were heart disease, lung disease, and stroke, according to STAT.
In fact, the complaints to the FDA show that not only does Actemra drugmaker Roche fail to provide adequate warning labels, but the drug may actually cause more adverse events like heart attack and stroke than other competing drugs that do provide accurate warning labels, according to the investigation.
“[There is] 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,” explained Charles Piller in the investigative STAT article.
Despite these FDA complaints and investigations into the drug, Actemra’s warning label still fails to reflect these reported increased risks, potentially jeopardizing the lives of rheumatoid arthritis patients.