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Published: August 29th, 2008
The arthritis drug Remicade has been linked to a number of serious and potentially life threatening injuries. In September 2008, stronger warnings were added about an increased risk of invasive fungal infections.
STATUS OF REMICADE LAWSUITS: Lawyers are evaluating research surrounding the potential safety concerns involving cancer and Remicade, as well as potential cases for individuals who developed fungal infections.
MANUFACTURER: Centocor and Johnson & Johnson
OVERVIEW: Remicade (infliximab) is an autoimmune disorder drug known as a Tumor Necrosis Factor (TNF) Blocker. It is approved by the FDA for treatment of psoriasis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.
It was the first TNF antagonist available in the United States, and has been used by more patients world-wide than the other medications in the same class, Enbrel and Humira, combined. It is a blockbuster drug for the pharmaceutical giant, Johnson & Johnson.
REMICADE CANCER SIDE EFFECTS: In 2004, a warning letter was sent to healthcare professionals indicating that Remicade had been associated with more cases of lymphoma among patients receiving the drug. A study published in the May 17, 2006 issue of the Journal of the American Medical Association (JAMA) found that Remicade side effects could triple the risk of developing cancer.
In June 2008, the FDA released an early communication about an ongoing safety review involving Remicade and a possible association with the development of lymphoma and other cancers among children and young adults and a Remicade black box cancer warning was added in August 2009.
At least 30 reports of childhood cancer were received by the FDA involving the use of TNF blockers. Other medications indicated in this early communication were Humira and Enbrel.
According to Johnson & Johnson, among children taking Remicade, most of the reports of juvenile cancer involved those treated for the bowel disorder Crohn’s disease. Approximately half of the cancers seen in all children and young adults taking TNF blockers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma, which is a cancer of cells in the immune system. Lymphoma is not a recognized complication of JIA (Juvenile Idiopathic Arthritis) or of Crohn’s disease. Other cancers reported included leukemia, melanoma and solid organ cancers.
REMICADE FUNGAL INFECTIONS: A number of users who were receiving TNF blockers, such as Remicade, have experienced fungal infections, such as histoplasmosis, blastomycosis and cocciioidmycosis. In several of these cases the infection resulted in death.
In September 2008, the FDA issued an alert to healthcare providers to provide new information about the risk of Remicade fungal infections. At that time the agency also indicated that new information will be added to the Remicade black box warning to ensure that doctors and consumers are aware of the risk, especially for those who live in or visit areas where fungus is prevalent.
Unfortunately, many cases of fungal infections from Remicade go undiagnosed by doctors, since the symptoms are similar to the flu. Symptoms could include cough, fever, fatigue, loss of weight, sweating and shortness of breath.