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Review Sermion Safety Reports submitted to FDA

Total Sermion reports: 2.
Sermion FDA safety alerts: 2003 2005 .
   Reported hospitalizations: 2.
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Sermion Side Effects Report #5670537-6
Physician from JAPAN reported SERMION problem on Mar 11, 2008. Male patient, 91 years of age, was diagnosed with nasopharyngitis, hyperlipidaemia and was treated with SERMION. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased. SERMION dosage: 15 MG/DAY. During the same period patient was treated with SIGMART, JUVELA, RHYTHMY, CRAVIT, KIPRES, MUCODYNE, FLUVASTATIN. Patient was hospitalized. Patient recovered.

Sermion Side Effects Report #5738893-8
SERMION problem was reported by a Physician from JAPAN on May 08, 2008. Male patient, 91 years of age, was diagnosed with nasopharyngitis, hypercholesterolaemia and was treated with SERMION. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased, blood glucose increased, blood lactate dehydrogenase increased, blood potassium increased, blood urea increased, lymphocyte count decreased. SERMION dosage: 15 MG/DAY. During the same period patient was treated with SIGMART, JUVELA, RHYTHMY, LEVOFLOXACIN, KIPRES, MUCODYNE, LOCHOL. Patient was hospitalized. Patient recovered.


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alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, blood creatinine increased, , %drugN% was diagnosed with nasopharyngitis, hyperlipidaemia and %drugN% was diagnosed with nasopharyngitis, hypercholesterolaemia and