The makers of Remicade, a biologic treatment for various inflammatory disorders involving the immune system, have updated information on the medication to include a Boxed Warning of an invasive fungal infection and a rare type of T-cell Lymphoma. Some of the infections and diseases that resulted from use of Remicade have been fatal.

More than one million people worldwide use Remicade for the treatment of inflammatory disorders such as plaque psoriasis, rheumadoid arthritis, psoriatic arthritis, Crohn’s disease in adults, pediatric Crohn’s disease, ulcerative colitis and ankylosing spondylitis.

The “Black Box Warning” was issued by the Food and Drug Administration (FDA) after reports of serious infections caused by viruses, fungi or bacteria that spread through the body, including tuberculosis (TB) and histoplasmosis. Postmarketing studies have shown cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma in patients treated with TNF blockers including Remicade. These cases have had a very aggressive disease course and have been fatal.

All reported Remicade cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine, both immunosuppressant medications, along with Remicade at or prior to diagnosis.

Patients are advised to discuss with their doctor any potential benefits and risks with taking Remicade, and be monitored closely by their doctors for signs and symptoms of TB during treatment of Remicade.

Negative side effects should be reported to the FDA online at www.fda.gov/medwatch, or by phone at 1-800-FDA-1088.



We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Beasley Allen attorney Danielle Mason warns of...

Could your medication be harming you? New drugs are approved by the FDA before they go to market, to...

Blood pressure medication linked to fetal injury, death

Women who are pregnant should avoid drugs used to treat hypertension, or high blood pressure, because...

Topamax linked to birth defects

Women of childbearing age who take the prescription medication Topamax should be aware that new studies...

Buyers Beware: Generic drug makers not required to...

A Supreme Court ruling on June 23 reversed separate U.S. appeals court rulings that would have held...

Popular diabetes drug linked to cancer

The FDA is evaluating Actos for a possible link to bladder cancer. Preliminary results from a long-term...

SSRI antidepressants increase risk of birth defects

A new study has verified that antidepressants known as selective serotonin reuptake inhibitors (SSRIs)...

Grateful and appreciative

You will never know how grateful and appreciative I am for all your efforts and achievements on my behalf. Your whole team is being remembered in my nightly prayers for your continued success in all your endeavors.

—Bettie