Generically known as infliximab, Remicade is an injectable artificial antibody that, bysuppressing part of the immune system, can be effective at treating various autoimmune disorders, including:
- Ankylosing spondylitis, a form of arthritis that primarily affects the pelvic region
- Crohn’s disease, a gastrointestinal condition accompanied by diarrhea, flatulence and bloating
- Psoriasis, a skin condition marked by silvery, scaly patches
- Psoriatic arthritis, inflammatory arthritis that primarily affects those with psoriasis
- Rheumatoid arthritis, joint inflammation that can result in the destruction of cartilage
- Ulcerative colitis, a form of inflammatory bowel disease marked by ulcers on the colon
Remicade’s first FDA approval was for Crohn’s disease in August 1998.
Remicade Side Effects
Despite being an effective immunosuppressant medication, Remicade has been reported, in rare cases, to cause a number of severe, life-threatening side effects, including (not limited to):
- Demyelinating central nervous system (CNS) disorders, any conditions that causes the destruction of the protective nerve sheath
- Liver damage
- Lymphoma (or other malignancies affecting solid tissues)
- Pancytopenia, lowered white and red blood cell counts
- Recurrence of Heptatitis C and/or tuberculosis
- Sepsis, any serious blood infection (as well as other types of severe infections)
- Thrombocytopenia, low blood platelet count
- Vasculitis, blood vessel inflammation that can weaken, thicken or scar blood vessels
Patients who are thinking of starting a course of Remicade should consult their doctor for a thorough evaluation of their risk, as this medication is not safe for everyone. Should Remicade patients develop any of the above life-threatening Remicade side effects, they should seek emergency medical attention in order to prevent further, possibly fatal damage to their health.
FDA Warnings About Remicade
By 2001, more than 84 Remicade patients reported developing tuberculosis—just one of the possible severe Remicade side effects. As a mounting number of patients reported developing a number of Remicade side effects, the U.S. Food and Drug Administration (FDA) took action. In August 2001, the FDA mandated that Centocor (the U.S. manufacturer of Remicade) include a “Black Box” warning label on all Remicade packaging that would warn patients of the danger of developing tuberculosis while taking this medication.
Black box warnings are the most serious level FDA warnings, as the next course of action would be to issue a full-fledged recall. In January 2002, the FDA updated the Black Box warning, now requiring Centocor to add warnings regarding the possibility of serious CNS disorders, MS and a number of other Remicade injuries.
Help for Injured Victims
If you or someone you love has developed an injury while taking Remicade,contact Gacovino, Lake and Associates for help. Our defective drug attorneys have extensive experience in pharmaceutical litigation. We will evaluate the details of your situation to determine if we can help you.