3/18/08 A black box warning has been issued for etanercept (Enbrel) regarding the risk for tuberculosis and other infections.
Previously, Enbrel prescribing information included a bold-face warning regarding the risk of infections and tuberculosis. The information is now in a boxed warning – the strongest warning that the FDA requires – and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including Enbrel, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection.
The boxed warning notes that data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies. The boxed warning further notes that, nonetheless, post-marketing cases of tuberculosis reactivation have been reported for TNF blockers, including Enbrel.
Clinical studies enrolling more than 20,000 patients worldwide have shown cases of tuberculosis in approximately 0.01% of patients treated with Enbrel. In trials enrolling more than 15,000 patients in the United States and Canada, about 0.007% of those patients treated with Enbrel developed tuberculosis.
atrial fib 6/06
endometrial hyperplasia 8/06
severe anemia 8/06
hysterectomy and pelvic nodes examined 11/06
atrial fib and congestive heart failure 1/07
anemia and bleeding issues 1/07 through 7/07. Severe congestive heart failure with ejection fraction around 18% 11/07 (hospitalized for 10 days)...then more atrial fib issues until ablation scheduled in 8/08. CT scan for ablation showed widespread lymph node tumors. I was dx with stage 3 Large Diffuse B cell Non-Hodgkin's lymphoma.
I decided to take my cardiologists advice and do the R-CHOP chemo. I made it through 3 before my heart function started to tank again. Finished chemo, had clear PET scan and 1 day later nearly die of cardiogenic shock, had inter-aortic balloon pump put in until I could have defib/pace put in.
I now have severe anxiety and depression on the state of my health and cannot function well. No one really told me what might happen as a result of the ENBREL. I certainly never would have taken it. I do not feel that I had "moderate to severe" RA, but I could not take methotrexate due to liver problems...so, I end up with all these other medical problems. Someone has to speak for us...we cannot continue to be poisoned.
Thanks.
Non Hodgkins Lymphoma. How is the frequency of this being tracked?? Part of my treatment includes Rituxan, which thankfully is helping to control my RA, but Cancer is a high price to pay, don't you think?
In fairness to Enbrel, it gave me years of mobility and gave me a "life" back. But, cancer is a high price to pay.
I would like to know if Arthritis Today has any mechanism tracking how many of us are getting lymphoma, which was a theoretical risk when I started taking it.
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