ADVERSE REACTIONS
Digestive Tract: Gastrointestinal symptoms are the most common reactions to PRECOSE®. In U.S. placebo-controlled trials, the incidences of abdominal pain, diarrhea, and flatulence were 19%, 31%, and 74% respectively in 1255 patients treated with PRECOSE® 50-300 mg t.i.d., whereas the corresponding incidences were 9%, 12%, and 29% in 999 placebo-treated patients. In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with PRECOSE® are a manifestation of the mechanism of action of PRECOSE® and are related to the presence of undigested carbohydrate in the lower GI tract.
If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.
Elevated Serum Transaminase Levels: See PRECAUTIONS.
Other Abnormal Laboratory Findings: Small reductions in hematocrit occurred more often in PRECOSE®-treated patients than in placebo-treated patients but were not associated with reductions in hemoglobin. Low serum calcium and low plasma vitamin B6 levels were associated with PRECOSE® therapy but are thought to be either spurious or of no clinical significance.
Post Marketing Adverse Event Reports:
Additional adverse events reported from worldwide post marketing experience include hypersensitive skin reactions (e.g. rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage (See PRECAUTIONS.)
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