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Monday, February 02, 2015 11:50:48 AM
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Safety Comparison to Existing Treatment
Both Viekira Pak and Harvoni drug labels indicate the following adverse reactions: fatigue, headache, nausea, diarrhea, insomnia and bilirubin elevations.
Adverse events reported for Viekira Pak that are absent from Harvoni’s drug label are listed as follows: ALT elevations, anemia, asthenia, cough, decrease in hemoglobin, dermatitis, dermatitis allergic, dermatitis contact, discolored feces, drug resistance, dyspnea, eczema, erythema, exfoliative rash, hemoglobin decreased, hyperbilirubinemia, increased INR, increasing alkaline phosphatase, irritability, jaundice, lack of appetite, liver inflammation, loss of therapeutic effect, muscle spasms, ocular icterus, other skin reactions, photosensitivity reaction, pruritus, pruritus generalized, psoriasis, rash, rash erythematous, rash generalized, rash macular, rash maculo-papular, rash papular, rash pruritic, skin exfoliation, skin reactions, ulcer, urticaria, vomiting and weakness.
Harvoni’s drug label indicates lipase elevations as the only adverse reaction not included in Viekira Pak’s drug label.
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