Investigators with STAT analyzed over 500,000 side-effect reports on a variety of rheumatoid arthritis drugs — including over 13,500 reports involving Actemra — and found 1,128 reports of Actrema patients who died.
Hundreds of those people died of heart failure or other conditions that are not on the label, like pancreatitis, which has a 50% risk of death.
The investigators 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.”
Actemra competes with other drugs for arthritis, such as Humira, Remicade and Enbrel. These other drugs carry warnings about the risk of heart failure, heart attacks, and strokes — Actemra does not.
The lack of similar warnings on Actemra may suggest it has a lower risk, but in a head-to-head study of Actemra and Enbrel, the rate of stroke and heart failure was actually 1.5-times higher in Actemra patients.
Enbrel carries a high-profile warning label against prescribing it to patients with cardiovascular disease because it is known to exacerbate or cause congestive heart failure.
The FDA has investigated Actemra several times since it was approved in 2010. One review found 118 deaths, including 42 deaths from heart attack or cardiac arrest as of August 2012, but they did not issue any warnings.
Another review found 258 reports of pancreatitis and 185 reports of interstitial lung disease among Actemra patients in clinical trials. The side effects were not added to the label after drug-makers said there was not enough evidence.
Experts are urging the FDA to immediately reconsider strengthening warnings on Actrema and investigate evidence of deadly side effects.