Cases,
Laws, Medical News
Case
Status
Print
this pageArthritis Drug, Remicade, May Increase Lymphoma Risk
WASHINGTON, DC — November 5, 2004 — The Food and Drug Administration (FDA) and the drug manufacturer, Centocor, are warning doctors that patients who take Remicade (infleximab) to treat rheumatoid arthritis or Crohn’s disease have an increased chance of developing the blood cancer lymphoma. Those Remicade users who are severely ill or who were exposed to drug therapies that suppress the immune system are at the highest risk. The prescribing label for Remicade will reflect the FDA alert.
Studies Point to Lymphoma–Remicade Link
In a clinical trial involving 2,410 participants, 3 patients with Crohn’s disease or rheumatoid arthritis who took Remicade developed lymphomas while those in the control group did not. The rate of lymphoma was three times higher in rheumatoid arthritis patients taking Remicade than in the general population, and six times higher for those in the Crohn’s disease/rheumatoid arthritis group taking Remicade than in the general population. Other studies have also pointed to an increased lymphoma risk from Remicade use.
How Remicade Works in Crohn’s Disease and Rheumatoid Arthritis
Crohn’s disease patients suffer from inflammation and fistulas (tunnel–like structures) in the intestine. This leads to abdominal pain and cramping. Rheumatoid arthritis patients have a painful form of arthritis that causes stiffness and swelling in joints on both sides of the body. Remicade works by blocking the activity of tumor necrosis factor or TNF–alpha, a protein associated with inflammation. TNF–alpha is present in high amounts in those with Crohn’s disease and rheumatoid arthritis.
Remicade is not related to the arthritis drug, Vioxx, a type of medication known as a COX–2 inhibitor that has been linked to an increased risk of heart attacks and strokes. However, a search of FDA documents reveals that in October, 2001, Centocor issued a warning to doctors about patients with congestive heart failure who were taking Remicade for Crohn’s disease or rheumatoid arthritis. In a clinical trial among 150 patients with congestive heart failure, 101 took Remicade and 49 took a placebo. Seven of those taking Remicade died compared with no deaths among the control group. As a result, the letter warned: “Do not initiate [Remicade] therapy in patients with congestive heart failure.” The Remicade prescribing information also warns about other possible side effects of the drug, including serious infections, allergic reactions, and lupus–like symptoms (chest discomfort, a rash that increases in the sun, and shortness of breath).
At Brayton Purcell, we are committed to helping people who have been injured by unsafe prescription drugs or over–the–counter medications. For more information about medical drugs and your legal rights, please feel free to contact us. We have been handling medically–related litigation for over 20 years.