FDA, Manufacturer Issue Warning on Drug
From Times Wire Reports
The Food and Drug Administration and manufacturer Centocor are warning doctors that patients receiving the drug Remicade to treat rheumatoid arthritis and Crohn’s disease have suffered sometimes fatal blood and central nervous system disorders.
The Malvern, Pa.-based company has revised the drug’s label.
Centocor, a subsidiary of healthcare product manufacturer Johnson & Johnson, said the FDA had been told of 580 adverse-reaction reports among 509,000 worldwide patients, said Craig Buchholz, a Centocor spokesman. Forty-four reports involved significant blood disorders.
