Research shows the immunosuppressant drug infliximab—sold under the brand name Remicade—increases the risk of infection by the bacteria Legionella and Listeria, injection site nerve damage, and skin cancer.
You shouldn’t have to go through more trouble to be compensated for the harm you’ve already suffered. The Rottenstein Law Group knows this and we want you to believe it. You need a sympathetic advocate who will represent only your interests—and who will make the process as painless as possible. If you’ve taken Remicade and have been harmed, contact RLG for a free consultation immediately.
What Is Remicade and What Is It Prescribed For?
Remicade is the brand name for the drug infliximab. Made and sold by Janssen Biotech, Inc., a subsidiary of health products giant Johnson & Johnson, Inc., this prescription medication is used to treat several autoimmune conditions. The U.S. Food and Drug Administration (FDA) first approved the drug in August 1998. Doctors prescribe it for Crohn’s disease, ulcerative colitis, rheumatoid arthritis (with methotrexate), ankylosing spondylitis, psoriatic arthritis, and plaque soriasis. It comes in 100 mg vials taken intravenously over a six- to eight-week period.
A member of the Tumor Necrosis Factor-alpha blocker (TNF-alpha blocker) class of immunosuppressant drugs, Remicade works by binding to TNF-alpha, a natural cell-signaling molecule that attaches to immune cells. TNF-alpha blockers prevent TNF-alpha from binding with cells because TNF-alpha can cause inflammation in tissues that leads to autoimmune diseases. By inhibiting it, Remicade prevents the autoimmune response.
Remicade Might Leave Users Vulnerable to Legionnaires’ Disease and Listeriosis
In September 2011, the FDA issued a Remicade warning in the form of a Drug Safety Communication stating that Remicade, along with other TNF-alpha blockers, increases the risk of infection by the bacteria Legionella and Listeria. The agency updated the drug’s label information to include a “black box” warning to reflect these developments. Black box warnings are the FDA’s most serious alert. Because TNF-alpha blockers reduce the immune system’s ability to fight infections, the body is vulnerable to potentially fatal infections by opportunistic organisms that attack multiple organ systems at once. Examples include:
- Mycobacterial (tuberculosis);
- Fungal (histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis); and
- Viral (hepatitis B).
Now, the FDA is warning the public that the drug leaves the body vulnerable to two other bacteria strains.
Legionella bacteria are named for their outbreak at a convention of the American Legion in a hotel in 1976. Members at the convention came down with a fatal pneumonia, which physicians named “Legionnaires’ disease.” They traced the source of the outbreak to bacteria in the hotel’s damp air conditioning system. These are the symptoms of Legionnaires’ disease:
- Dry cough;
- Muscle aches;
- Loss of appetite;
- Loss of coordination;
- Impaired cognition;
- Low heart rate despite fever;
- Renal, liver, and electrolyte disorder; and
Legionella infection can also cause a weaker disease called Pontiac fever.
According to the FDA’s Adverse Event Reporting System, between 1999 and 2010, about 80 patients developed Legionella infections after using a TNF-alpha blocker. Most were using the drug for rheumatoid arthritis. Many of the 80 patients were also taking methotrexate, corticosteroids, or both, with Remicade. Fourteen of the 80 patients died.
The Listeria genus of bacteria is named after British scientist and developer of antiseptics Joseph Lister. Listeria infections, called “listeriosis,” last seven to ten days and have the following symptoms:
- Muscle aches;
- Diarrhea (less common); and
- Meningitis (if the infection spreads to the nervous system).
The disease mostly affects newborns, the elderly, and pregnant women. The listeria bacteria mainly enter through contaminated food products, particularly tainted dairy ones.
The FDA identified 26 cases in English language medical publications of TNF-alpha blocker users coming down with listerioris. These infections resulted in meningitis, bacteremia, endophthalmitis, and sepsis. As with the Legionella-infected patients, many Listeria-infected patients were also using other immunosuppressive drugs. Seven patients died of their infections.
Remicade Might Cause Injection Site Nerve Damage
On November 19, 2013, Law360 reported that an Indiana couple sued Janssen Biotech, Inc., alleging Remicade caused the wife to suffer nerve damage to the injection site. The case was filed in the Philadelphia County Court of Common Pleas. According to a study produced by the Institute of Safe Medication Practices (ISMP), the FDA had received 17 adverse event reports from Remicade users suffering from nerve fiber demylination.
Remicade Might Cause Skin Cancer
On November 6, 2013, the FDA updated Remicade’s drug label to include an entry for skin cancer due to post-marketing reports from users who developed the condition. The aforementioned ISMP report discovered 110 adverse event reports from Remicade users who developed skin cancer. The FDA’s warning notes that skin cancer tended to develop in children, adolescents, and young adults on Remicade as opposed to older people.
RLG’s Remicade Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Remicade lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Remicade lawsuit on your behalf if necessary. RLG will also keep you up to date on any Remicade class action lawsuits, FDA Remicade warnings, and Remicade FDA recall announcements. If you have taken Remicade and believe it harmed you, contact RLG today.