Remicade – An Insight

Remicade, an immunosuppressant is used for the treatment of rheumatoid arthritis, Crohn’s Disease and juvenile arthritis. It is approved by the Food and Drug Administration and is administered subcutaneously through injection.

Fever, weight loss, dry cough, body aches, fever with chills and flu symptoms are common side effects of Remicade. Patients using Remicade are at a higher risk for developing severe side effects including infections or ailments that may lead to hospitalization and even death. As Remicade affects the immune system, it decreases the body’s ability to fight infections like tuberculosis. Remicade blocks tumor necrosis factor (TNF), it may cause lymphomas including other malignancies.

Recently, the U.S. Food and Drug Administration issued Black Box Warning against Remicade. The Black Box Warning label is the harshest warning label applied to any drug by FDA. Drugs that carry severe side effects and are life threatening are given this black box warning.

Black Box Warning against Remicade

In September 2008, the U.S. Food and Drug Administration declared to issue stronger warnings for four medicines used for the treatment of rheumatoid arthritis. Therefore, black box warning was issued against the four drugs including Remicade. The Black Box Warning label is the harshest warning label applied to any drug by FDA. Drugs that carry severe side effects and are life threatening are given this black box warning.

This warning is issued only after the medical studies and research establish that a particular drug is associated with sever side effects.

These four drugs belong to a class of drugs called immunosuppressant. These drugs lower the ability of the immune system to fight off the infections and diseases. Regular consumption of these medications can cause serious complications.

FDAs declaration recommended that although the use of these medications offers relief from the symptoms of Crohn’s disease, rheumatoid arthritis and juvenile arthritis, there is high possibility of developing infection due to the weak immune system.

FDA is worried about the information that appears to be overlooked or neglected by the medical community. Large no. of patients taking Remicade developed a fungal infection called histoplasmosis. Of the 240 patients suffering from this infection, 20 percent dies.

Histoplasmosis

Histoplasmosis is a respiratory infection and its symptoms are similar to that of flu. If a patient, suffering from this infection does not receive timely treatment than there is high possibility that the infection may spread to other parts of the body.

FDA asked the patients using Remicade to consult a doctor immediately on developing following symptoms:

• Cough
• Shortness of breathe
• Persistent fever
• Fatigue

The above listed symptoms could be the signs of fungal infection.

Legal Advice

Patients using Remicade should be completely aware about the side effects associated with this drug. Individuals suffering from the side effects of Remicade are eligible for monetary compensation. Therefore, they should seek the advice of an experienced pharmaceutical lawyer who will assist in filing a lawsuit against the manufacturers for the damages caused to you.