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Bristol-Myers Squibb Videx

Executive Summary

Once-daily oral dose of two 200 mg didanosine chewable tablets approved by FDA Oct. 28. Videx' revised label also includes risk information about pancreatitis in patients receiving triple combination therapy including Videx, Bristol's Zerit (stavudine) and a protease inhibitor. Labeling has also added a precaution that "pancreatitis resulting in death was observed in one patient who received Videx plus stavudine plus nelfinavir [Warner-Lambert's Viracept]...and in one patient who received Videx plus stavudine plus indinavir [Merck's Crixivan]." Two of 68 patients receiving Videx/Zerit/Crixivan and Bristol's Droxil (hydroxyurea) died from pancreatitis, labeling continues

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