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Review Silece Safety Reports submitted to FDA

Total Silece reports: 2.
Silece FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Silece Side Effects: oculomucocutaneous syndrome.
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Silece Side Effects Report #5391505-8
Physician from JAPAN reported SILECE problem on July 10, 2007. Male patient, weighting 137.6 lb, was diagnosed with insomnia, hypertension, cerebral infarction and was treated with SILECE. After drug was administered, patient experienced the following problems/side effects: oculomucocutaneous syndrome. SILECE dosage: unknown. During the same period patient was treated with NIVADIL, ALMARL, ADALAT, TENORMIN, PLAVIX. Patient was hospitalized. Patient recovered.

Silece Side Effects Report #5391505-8
SILECE problem was reported by a Physician from JAPAN on July 10, 2007. Male patient, weighting 137.6 lb, was diagnosed with insomnia, hypertension, cerebral infarction and was treated with SILECE. After drug was administered, patient experienced the following problems/side effects: oculomucocutaneous syndrome. SILECE dosage: unknown. During the same period patient was treated with NIVADIL, ALMARL, ADALAT, TENORMIN, PLAVIX. Patient was hospitalized. Patient recovered.


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oculomucocutaneous syndrome, oculomucocutaneous syndrome, , was diagnosed with insomnia, hypertension, cerebral infarction and was diagnosed with insomnia, hypertension, cerebral infarction and