Humira Side Effects
Research shows the immunosuppressant/arthritis drug adalimubab—sold under the brand name Humira—increases the risk of infection by the bacteria Legionella and Listeria.
Humira is the brand name for the drug adalimubab. Made and sold by Abbott Laboratories, this prescription medication is used to treat several autoimmune conditions. The U.S. Food and Drug Administration (FDA) first approved the drug in December 2002, and doctors prescribe it for rheumatoid arthritis (with methotrexate), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, and plaque soriasis. It comes in 40 mg/0.8 mL syringes and vials injected subcutaneously.
A member of the Tumor Necrosis Factor-alpha blocker (TNF-alpha blocker) class of immunosuppressant drugs, Humira 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 tissue inflammation that leads to autoimmune diseases. By inhibiting it, Humira prevents the autoimmune response.
In September 2011, the FDA issued a Humira warning in the form of a Drug Safety Communication stating that Humira, 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.
Legionella bacteria are named for their eponymous 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:
•Loss of appetite;
•Loss of coordination;
•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. Fourteen of the 80 patients died.
The Listeria genus of bacteria is named after the British scientist and developer of antiseptics, Joseph Lister. Listeria infections, called “listeriosis,” last seven to ten days and have the following symptoms:
•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.
Have You Suffered Humira Side Effects?
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