Remicade OK'd for spinal arthritis on same day warning issued

12/21/2004 | Wall Street Journal, The

On the same day Johnson & Johnson's Centocor unit announced FDA approval of Remicade for treating a form of spinal arthritis, the parent company issued a warning the drug could be associated with an increased risk of liver failure and pneumonia. The drug previously was indicated only for treating Crohn's disease and rheumatoid arthritis, injected during a visit to a clinic. Centocor said there was no proof in the trials Remicade caused the liver damage detected in three patients on the drug, but the label is to be changed to warn of such possible damage, plus an increased risk of pneumonia.

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