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).