FDA Approves Controversial drug Remicade for Kids
May 22, 2006 – Just two days after a study appeared in the Journal of the American Medical Association linking Remicade to a number of cancers and serious infections, the FDA approved the drug for use in children with Crohn’s disease.
The approval comes despite reports of an aggressive and often deadly form of lymphoma in adolescents and young adults with the disease.
Remicade initially received FDA approval in 1998 for the treatment of rheumatoid arthritis and Crohn’s disease in adults – both of which are autoimmune diseases resulting in painful, sometimes debilitating, inflammation.
Doctors have found Remicade helpful in treating chronic inflammatory illnesses because it blocks a protein that contributes to inflammation.
However, Remicade has been linked to a variety of serious, potentially fatal, conditions including lymphoma, liver damage, and tuberculosis.
In addition to these already known dangers of Remicade, researchers at the Mayo Clinic found that patients taking the drug were three times more vulnerable for developing certain cancers including skin, gastrointestinal, breast, and lung tumors.
The study also found that patients taking Remicade were more susceptible to serious infections like pneumonia and cellulitis.
The safety and effectiveness of Remicade in children younger than six has not been studied. The FDA said it is working with Centocor, the drugmaker, to revise the drug’s labeling.
For more information on Remicade side effects, please contact us.
