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Review Loftan Safety Reports submitted to FDA

Total Loftan reports: 2.
Loftan FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Loftan Side Effects: suicide attempt, somnolence, intentional overdose, acidosis.
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Loftan Side Effects Report #5397790-0
Health Professional from GERMANY reported LOFTAN problem on July 24, 2007. Female patient, 37 years of age, weighting 220.5 lb, was treated with LOFTAN. After drug was administered, patient experienced the following problems/side effects: acidosis, intentional overdose, somnolence, suicide attempt. LOFTAN dosage: 4MG SEE TEXT. During the same period patient was treated with BUSCOPAN PLUS, IBUPROFEN, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Loftan Side Effects Report #5397790-0
LOFTAN problem was reported by a Health Professional from GERMANY on July 24, 2007. Female patient, 37 years of age, weighting 220.5 lb, was treated with LOFTAN. After drug was administered, patient experienced the following problems/side effects: acidosis, intentional overdose, somnolence, suicide attempt. LOFTAN dosage: 4MG SEE TEXT. During the same period patient was treated with BUSCOPAN PLUS, IBUPROFEN, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.


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