Roche's arthritis drug may be associated with hundreds of patient deaths, STAT finds

Actemra first hit the U.S. market in 2010 as Roche's breakthrough treatment for rheumatoid arthritis, which affects approximately 1.5 million people. The medication wasn't associated with heart attacks, heart failure or life-threatening lung complications like other arthritis medications. However a recent STAT investigation found hundreds of patients taking Actemra have died of such conditions.

For the investigation, STAT analyzed more than 500,000 side-effect reports involving rheumatoid arthritis drugs. The analysis revealed patients taking Actemra had just as high a risk of experiencing a heart attack, stroke and heart failure, among other conditions, as patients taking competing drugs. While most medications warn about these potential side effects, Actemra does not.

The FDA has received reports of 1,128 deaths among patients who were taking Actemra, although the agency is not able to assess whether the medication directly contributed to the deaths, according to STAT. Neither the FDA nor Roche has made an effort to change the drug's label.

"We've done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven't ramped up the standards of post-marketing surveillance to make sure that what's been out there for several years is safe and effective," Vinay Prasad, MD, an oncologist and medical ethicist at the Oregon Health and Science University in Portland, told STAT. "The system is broken, and all the financial incentives are lined up to keep it broken."

An undisclosed group of experts who reviewed Actemra data compiled by STAT said, "FDA should immediately consider warnings for heart failure and pancreatitis," according to the report. The evidence suggesting Actemra may contribute to heart attacks, strokes, and interstitial lung disease was less convincing, but merited further analysis, the researchers added.

Jeffrey Siegel, MD, senior medical director for rheumatology products at Roche, told STAT the publication's investigation raised "important questions that we think about all the time … We try very hard not to be complacent and to fully explore these issues."

In May, the FDA expanded the approved use of Roche's arthritis drug to include treatment of giant cell arteritis, a potentially fatal autoimmune condition characterized by the swelling of arteries in the head and aorta.

The FDA declined STAT's request for comment.

To read the STAT article in its entirety, click here.

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