Enbrel side effects could include risk of serious infections, tuberculosis
Published: May 4th, 2008 • Comments: 5
A new “black box” warning has been added to Enbrel regarding side effects which could increase the risk of tuberculosis, bacterial sepsis and other infections. The warning indicates that Enbrel side effects could lead to a risk of serious infections which may require hospitalization or possibly lead to death. (Link: FDA MedWatch).
Enbrel (etanercept) is an injection prescribed for treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idopathic arthritis. It is marketed and sold by Amgen, Inc. and Wyeth, and was originally approved by the FDA in 1998.
Indications about the possibility of infections associated with Enbrel were previously printed in bold-face type in the package insert. However, those warnings will be strengthened and placed in a prominent “black box”, which is the strongest warning that can be placed on a prescription medication. The warning will also contain information about the occurrence of tuberculosis among those taking Enbrel.
Remicade and Humira, which are other medications used to treat rheumatoid arthritis, have had “black box” warnings about the risk of side effects that could lead to tuberculosis. The FDA has indicated that since rare cases of tuberculosis have also been seen in patients treated with Enbrel, it is necessary to place the boxed warning on Enbrel as well.
Rheumatologists, dermatologists and other healthcare providers have been advised to screen patients for latent tuberculosis infection before prescribing Enbrel, to reduce the risk of TB as a side effect of the drug. They have also been advised to educate patients about the symptoms of infection and to monitor for infection signs and symptoms during and after treatment with the drug. (Link: Amgen/Wyeth Dear Healthcare Professional Letter).
Pingback by Enbrel Lawsuits — AboutLawsuits.com on 10 May 2008:
[...] “black box” warning added in 2008 also included information about cases of tuberculosis associated with use of Enbrel injections. The FDA and manufacturers indicated that healthcare providers should screen their patients for [...]
Comment by Catherine on 27 February 2009:
Hi I have bad RA and i have been on Enbrel 1996 in 2001 I got Breast Cancer stage 2 I called the company and ask if anyone got cancer from Enbrel they told me no so I still take it.
Thanks, Cathy
Comment by Jen K. on 15 October 2009:
Severe RA & Sjogrens. Have been on Enbrel for 4 years.
Diagnosed w/ breast cancer 1 month ago. Why???
Enbrel needs further testing investigating.
Comment by treena on 22 October 2009:
I was on Enbrel for 3mth and in that little bit of time frame that i took it the worst time that i have ever imagin joint pain and stiffness ! And they say it is suppose to help you with ARTHITIS NOT MAKE YOU GET IT! Pretty weird I didn’t have it before i started the ENBREL.
Comment by Len on 17 November 2009:
I was in a clinical trial where Enbrel was used to determine if a NEW drug (stelera) was comparable. I had little to no psoriasis but after 12 injections with Enbrel my condition became exacerbated. The test drug made ALL lesions disappear, but they returned after the last test dosage. I was sure that the Enbrel was the causal effect of my condition which lasts to this day.