Remicade Legal Information Center

Research shows the immunosuppressant drug infliximab—sold under the brand name Remicade—increases the risk of infection by the bacteria Legionella and Listeria.

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:

Bacterial;
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

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:

Fever;
Chills;
Dry cough;
Muscle aches;
Headache;
Tiredness;
Loss of appetite;
Loss of coordination;
Diarrhea;
Vomiting;
Confusion;
Impaired cognition;
Low heart rate despite fever;
Renal, liver, and electrolyte disorder; and
Pneumonia.

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.

Listeriosis

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:

Fever;
Muscle aches;
Vomiting;
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.

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.