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Review Glysennid Safety Reports submitted to FDA

Total Glysennid reports: 8.
Glysennid FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 2.
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FDA Reported Glysennid Side Effects:
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Glysennid Side Effects Report #5649539-1
Physician from JAPAN reported GLYSENNID problem on Feb 26, 2008. Female patient, 60 years of age, was diagnosed with insomnia and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: delirium, hallucination, visual, somnambulism. GLYSENNID dosage: unknown. During the same period patient was treated with URSO, FAMOTIDINE, MAGNESIUM OXIDE, GASMOTIN, ALDACTONE, MYSLEE. Patient recovered.

Glysennid Side Effects Report #5766089-2
GLYSENNID problem was reported by a Physician from JAPAN on June 06, 2008. Male patient, weighting 100.8 lb, was diagnosed with constipation, cerebral infarction, insomnia and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pancytopenia. GLYSENNID dosage: unknown. During the same period patient was treated with PLAVIX, ROHYPNOL. Patient died on 05/16/2008.

Glysennid Side Effects Report #5692003-4
Health Professional from JAPAN reported GLYSENNID problem on Sept 11, 2007. Female patient, weighting 90.39 lb, was diagnosed with hypertension, cerebrovascular disorder and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: mesenteric occlusion. GLYSENNID dosage: 36 MG. During the same period patient was treated with SELBEX, SEVEN EP, ALLEGRA, FERROMIA, AMLODIN, BLOPRESS, CLOPIDOGREL. Patient died on 09/05/2007.

Glysennid Side Effects Report #5697968-2
GLYSENNID problem was reported by a Health Professional from JAPAN on Sept 11, 2007. Female patient, weighting 90.39 lb, was diagnosed with hypertension, cerebrovascular disorder and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: mesenteric occlusion. GLYSENNID dosage: 36 MG. During the same period patient was treated with SELBEX, SEVEN EP, ALLEGRA, FERROMIA, AMLODIN, BLOPRESS, CLOPIDOGREL. Patient died on 09/05/2007.


Glysennid Side Effects Report #5701597-1
Health Professional from JAPAN reported GLYSENNID problem on Apr 03, 2008. Female patient, 60 years of age, was diagnosed with insomnia and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: delirium, hallucination, visual, somnambulism. GLYSENNID dosage: unknown. During the same period patient was treated with URSO, MAGNESIUM OXIDE, GASTER D, GASMOTIN, ALDACTONE, MYSLEE. Patient recovered.

Glysennid Side Effects Report #5704702-6
GLYSENNID problem was reported by a Health Professional from JAPAN on Apr 08, 2008. Female patient, weighting 90.39 lb, was diagnosed with hypertension, cerebrovascular disorder and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: mesenteric occlusion. GLYSENNID dosage: 36 MG. During the same period patient was treated with SELBEX, SEVEN EP, ALLEGRA, FERROMIA, AMLODIN, BLOPRESS, CLOPIDOGREL. Patient died on 09/05/2007.

Glysennid Side Effects Report #5707906-1
Health Professional from JAPAN reported GLYSENNID problem on Apr 04, 2008. Female patient was diagnosed with painful defaecation, depression, insomnia, nasopharyngitis and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: ileus. GLYSENNID dosage: 24 MG. During the same period patient was treated with DEPAKENE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, BRUFEN, ASTOMIN, DIAZEPAM. Patient was hospitalized. Patient recovered.

Glysennid Side Effects Report #5723944-7
GLYSENNID problem was reported by a Health Professional from JAPAN on Apr 21, 2008. Female patient was diagnosed with painful defaecation, depression, insomnia, nasopharyngitis and was treated with GLYSENNID. After drug was administered, patient experienced the following problems/side effects: ileus. GLYSENNID dosage: 24 MG. During the same period patient was treated with DEPAKENE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, BRUFEN, ASTOMIN, CERCINE. Patient was hospitalized. Patient recovered.


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delirium, hallucination, visual, somnambulism, interstitial lung disease, pancytopenia, mesenteric occlusion, , %drugN% was diagnosed with insomnia and %drugN% was diagnosed with constipation, cerebral infarction, insomnia and