As of September 2011, when the FDA issued a safety alert warning that patients using Remicade and other types of TNF inhibitors, are at an increased risk for infections caused by two bacterias, Legionella and Listeria. The drug soon had a black box label warning, which is the most serious alert to be given by the FDA. Due to the fact TNF alpha blockers reduce immune system ability in fighting infections, the body then becomes much more vulnerable to developing these fatal infections by organisms that can attack more than one organ system at a time.
Some examples include:
- Viral (Hepatitis B)
Over the past decade, there have been at least 100 reports of pathogen infections caused by Remicade, including 14 deaths. Patients who mostly suffered from these symptoms included the ages of 26-71. Within a month, these patients were beginning to show signs of serious and life threatening viral and bacterial infections. Other patients showed symptoms of infection up to 6 years after beginning their TNF inhibitor therapy.
Remicade is sold by Jansessen Biotech, Inc., the prescription medication had been used in treating many autoimmune conditions. The FDA had first approved Remicade in August 1998 as a prescription for rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and more. It was given in 100mg viles over a 6-8 week time period. Now, the FDA has asked doctors and other health care professionals to highly reconsider prescribing Remicade and types of these drugs to patients over 65 years who have immunosuppressant disorders.
If you feel you have a been a victim of Remicade, find out your legal options today. You may be eligible to file a claim against the product manufacturer for any pain, suffering, or medical damages their product may have caused you.