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Review Difflam Safety Reports submitted to FDA

Total Difflam reports: 5.
Difflam FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 7.
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FDA Reported Difflam Side Effects: arteriospasm coronary, laryngospasm.
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Difflam Side Effects Report #5598550-8
Physician from UNITED KINGDOM reported DIFFLAM problem on Jan 17, 2008. Female patient was diagnosed with colon cancer and was treated with DIFFLAM. After drug was administered, patient experienced the following problems/side effects: arteriospasm coronary. DIFFLAM dosage: unknown. During the same period patient was treated with BONJELA, LOPERAMIDE, FLUOROURACIL, LEUCOVORIN, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Difflam Side Effects Report #5377382-X
DIFFLAM problem was reported by a Physician from UNITED KINGDOM on June 25, 2007. Female patient was diagnosed with colon cancer and was treated with DIFFLAM. After drug was administered, patient experienced the following problems/side effects: arteriospasm coronary. DIFFLAM dosage: unknown. During the same period patient was treated with BONJELA, LOPERAMIDE, FLUOROURACIL, LEUCOVORIN CALCIUM, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Difflam Side Effects Report #5377382-X
Physician from UNITED KINGDOM reported DIFFLAM problem on June 25, 2007. Female patient was diagnosed with colon cancer and was treated with DIFFLAM. After drug was administered, patient experienced the following problems/side effects: arteriospasm coronary. DIFFLAM dosage: unknown. During the same period patient was treated with BONJELA, LOPERAMIDE, FLUOROURACIL, LEUCOVORIN CALCIUM, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Difflam Side Effects Report #5716572-0
DIFFLAM problem was reported by a Physician from UNITED KINGDOM on Apr 15, 2008. Female patient was diagnosed with colon cancer and was treated with DIFFLAM. After drug was administered, patient experienced the following problems/side effects: arteriospasm coronary. DIFFLAM dosage: unknown. During the same period patient was treated with BONJELA, LOPERAMIDE, FLUOROURACIL, LEUCOVORIN CALCIUM, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Difflam Side Effects Report #5349337-2
Physician from UNITED KINGDOM reported DIFFLAM problem on May 29, 2007. Female patient was diagnosed with colon cancer and was treated with DIFFLAM. After drug was administered, patient experienced the following problems/side effects: laryngospasm. DIFFLAM dosage: unknown. During the same period patient was treated with BONJELA, LOPERAMIDE, FLUOROURACIL, OXALIPLATIN, LEUCOVORIN CALCIUM. Patient was hospitalized. Patient recovered.


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