FDA Tells J&J; to Drop Remicade Brochure
U.S. regulators ordered Johnson & Johnson’s Centocor unit to stop using a sales brochure for its Remicade rheumatoid arthritis drug because the document overstated the drug’s benefits and omitted risks.
The Food and Drug Administration said the material “suggests Remicade is safer and more effective than has been demonstrated by substantial evidence,” in a letter to the New Brunswick, N.J.-based company posted on the FDA’s website.
Johnson & Johnson in December wrote to doctors about liver damage in patients taking Remicade and added a warning to its label, citing reports of liver failure, hepatitis and other complications.
J&J;’s Centocor unit, which sells Remicade, received the letter Friday. The brochure cited by the FDA expired in October and is no longer being published by the company, a spokesman said.
Shares of Johnson & Johnson fell 60 cents to $66 on the NYSE.
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