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# FDA Reviews Safety Data on Roche’s Actemra
- URL: https://www.fdaweb.com/fda-reviews-safety-data-on-roches-actemra/
- Published: 2017-06-06T12:00:00.000Z
- Updated: 2026-09-14T22:27:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138856

FDA says it is reviewing the safety of Roche’s Actemra (tocilizumab) for treating adults with moderate to severe rheumatoid arthritis. A *Stat News* [article 6/5](http://sco.lt/70KomP?ref=fdaweb.com) raised safety concerns after it analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and “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. Most of those medications warn about these risks on their labels. Actemra does not.” The article was also very critical of FDA for not warning of these risks sooner.

FDA approved the BLA in 2010 for treating adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved products. “Actemra recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies,” according to an agency release posted at the time. “These safety concerns include elevated liver enzymes, elevated low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations.” Actemra was also described as the first interleukin-6 receptor-inhibiting monoclonal antibody.

Asked to comment on the *Stat News* article, a CDER official told ***FDA Webview*** 6/6: “FDA evaluates the safety of products on an ongoing basis and updates the product label with new safety information when appropriate. When tocilizumab was approved, FDA required a post-marketing safety trial to evaluate the risk of cardiovascular events. That study has been completed and submitted to the FDA and is currently under review. If new safety issues are identified, we will update the product label as needed with this new information.”

  
Experts who examined the data at STAT’s request said FDA should immediately consider warnings for heart failure and pancreatitis. They said the evidence that Actemra might increase the risk of heart attacks, strokes, and interstitial lung disease, a sometimes-fatal scarring of lung tissue, is less convincing but warrants further review.