Research shows the immunosuppressant drug golimumab—sold under the brand name Simponi—increases the risk of infection by the bacteria Legionella and Listeria. The Rottenstein Law Group, a Simponi law firm, compassionately advocates for those who have suffered Simponi side effects. If you’ve taken Simponi and believe it left you vulnerable to a bacterial infection, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Simponi recalls and Simponi class action lawsuits.
What Is Simponi and What Is It Prescribed For?
Simponi is the brand name for the drug golimumab. Made and sold by Centocor Biotech, Inc., now Janssen Biotech, Inc., a Johnson & Johnson subsidiary, this prescription medication is used to treat several autoimmune conditions. The U.S. Food and Drug Administration (FDA) first approved the drug in April 2009. Doctors prescribe it for rheumatoid arthritis (with methotrexate), active psoriatic arthritis in adults (with or without methotrexate), and active anklylosing spondylitis in adults. It comes in 50 mg/0.5 mL subcutaneous injections, occuring monthly.
A member of the Tumor Necrosis Factor-alpha blocker (TNF-alpha blocker) class of immunosuppressant drugs, Simponi 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 an inflammation in tissues that leads to autoimmune diseases. By inhibiting it, Simponi prevents the autoimmune response.
Simponi Might Leave Users Vulnerable to Legionnaires’ Disease and Listeriosis
In September 2011 the FDA issued a Simponi warning in the form of a Drug Safety Communication stating that Simponi, 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, 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 Simponi. 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.
RLG’s Simponi 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 Simponi 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 Simponi lawsuit on your behalf if necessary. RLG will also keep you up to date on any Simponi class action lawsuits, FDA Simponi warnings, and Simponi FDA recall announcements. If you have taken Simponi and believe it harmed you, contact RLG today.