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The Remicade® Label Has Been Revised

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Remicade® Linked to Liver Damage and Pneumonia

WASHINGTON, DC — January 07, 2005 — Some patients treated with Remicade® have experienced severe liver problems and pneumonia, according to a letter sent to doctors by Centocor, the drug’s manufacturer. Remicade® (infleximab) is used to treat the symptoms of rheumatoid arthritis and Crohn’s disease, a disorder that causes inflammation and fistulas (tunnel–like structures) in the intestine. Recently, Remicade® was also approved to treat a type of spinal arthritis called ankylosing spondylitis.

The revised Remicade® label lists these potential side effects: acute liver failure, jaundice or yellowing of the skin and eye whites, hepatitis, and cholestasis (build–up of bile in the liver). In rare cases, patients who took Remicade® died or had to have liver transplants. The label now recommends that a patient discontinue taking Remicade® if he or she develops jaundice or elevated liver enzymes. Centocor has also added a warning that Remicade® users run the risk of developing pneumonia.

Remicade® May Increase Lymphoma Risk

The warning about liver damage and pneumonia comes just months after Centocor sent another letter to doctors warning that patients who take Remicade® may have an increased chance of developing the blood cancer lymphoma. In one study, the rate of lymphoma was three times higher in rheumatoid arthritis patients taking Remicade® than in the general population. See Remicade® May Increase Lymphoma Risk for more details.

Remicade® and Congestive Heart Disease

Over three years ago, Centocor also issued an alert about Remicade® and congestive heart failure. In a clinical trial among 150 patients with congestive heart failure, 101 took Remicade® and 49 took fake pills or placebos. Seven of those taking Remicade® died compared with no deaths among the control group. As a result, Centocor wrote a letter to doctors that warned: “Do not initiate [Remicade®] therapy in patients with congestive heart failure.”

Although Remicade® may affect patients with congestive heart failure, it is not related to the arthritis drug, Vioxx®, a type of medication known as a COX–2 inhibitor that may increase the risk of heart attacks and strokes. Vioxx® was withdrawn from the market in September of last year.

Other Remicade® Side Effects

Other possible side effects of Remicade® include serious fungal infections, tuberculosis, allergic reactions, and lupus–like symptoms (chest discomfort, a rash that increases in the sun, and shortness of breath). For a complete description of Remicade® risks, see the prescribing instructions.

At Brayton Purcell, we are committed to helping people who have been injured by unsafe prescription medicines. For more information about medical drug injuries and your legal options, please feel free to contact us. We have been handling medically–related consumer cases for over 20 years, and work hard to defend the legal rights of our clients.

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Possible Remicade® Side Effects: