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Review Josacine Safety Reports submitted to FDA

Total Josacine reports: 2.
Josacine FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Josacine Side Effects:
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Josacine Side Effects Report #5474091-3
Health Professional from FRANCE reported JOSACINE problem on Sept 21, 2007. Female patient, 95 years of age, was diagnosed with wound infection, arrhythmia, type 2 diabetes mellitus, unevaluable event and was treated with JOSACINE. After drug was administered, patient experienced the following problems/side effects: anaemia, haematoma, hypovolaemic shock, international normalised ratio increased, petechiae. JOSACINE dosage: unknown. During the same period patient was treated with PREVISCAN, ACARBOSE, GLICLAZIDE, CAPTEA, CARDENSIEL, CIPROFIBRATE, ENDOTELON. Patient was hospitalized. Patient recovered.

Josacine Side Effects Report #5491603-4
JOSACINE problem was reported by a Physician from FRANCE on Oct 11, 2007. Female patient, 95 years of age, was diagnosed with wound infection, arrhythmia, type 2 diabetes mellitus, unevaluable event and was treated with JOSACINE. After drug was administered, patient experienced the following problems/side effects: anaemia, haematoma, hypovolaemic shock, international normalised ratio increased, petechiae. JOSACINE dosage: unknown. During the same period patient was treated with PREVISCAN, ACARBOSE, GLICLAZIDE, CAPTEA, CARDENSIEL, CIPROFIBRATE, ENDOTELON. Patient was hospitalized. Patient recovered.


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anaemia, haematoma, hypovolaemic shock, international normalised ratio increased, petechiae, anaemia, haematoma, hypovolaemic shock, international normalised ratio increased, petechiae, , was diagnosed with wound infection, arrhythmia, type 2 diabetes mellitus, unevaluable event and was diagnosed with wound infection, arrhythmia, type 2 diabetes mellitus, unevaluable event and