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Review Ibuhexal Safety Reports submitted to FDA

Total Ibuhexal reports: 5.
Ibuhexal FDA safety alerts: No.
Reported deaths: 2    .
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FDA Reported Ibuhexal Side Effects: weight increased, visual disturbance, transient ischaemic attack, fall, road traffic accident, epidermolysis bullosa, resuscitation, respiratory failure, laryngeal oedema, brain hypoxia, brain death.
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Ibuhexal Side Effects Report #5601109-7
Physician from GERMANY reported IBUHEXAL problem on Jan 14, 2008. Male patient, 38 years of age, weighting 242.5 lb, was diagnosed with pharyngolaryngeal pain and was treated with IBUHEXAL. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, hypoxic encephalopathy, ischaemic hepatitis, laryngeal oedema, myocardial ischaemia, respiratory failure, resuscitation. IBUHEXAL dosage: 400 MG, ONCE/SINGLE IN THE EVENING, ORAL. During the same period patient was treated with WICK MEDINAIT, MALLEBRIN. Patient died on 04/09/2007.

Ibuhexal Side Effects Report #5424511-5
IBUHEXAL problem was reported by a Consumer or non-health professional from GERMANY on Aug 16, 2007. Male patient, 84 years of age, weighting 154.3 lb, was diagnosed with contusion and was treated with IBUHEXAL. After drug was administered, patient experienced the following problems/side effects: fall, transient ischaemic attack, visual disturbance, weight increased. IBUHEXAL dosage: unknown. During the same period patient was treated with ACETYLSALICYLIC ACID SRT. Patient recovered.

Ibuhexal Side Effects Report #5429255-1
Physician from GERMANY reported IBUHEXAL problem on Aug 23, 2007. Male patient, 84 years of age, weighting 154.3 lb, was diagnosed with contusion and was treated with IBUHEXAL. After drug was administered, patient experienced the following problems/side effects: fall, road traffic accident, transient ischaemic attack, visual disturbance, weight increased. IBUHEXAL dosage: unknown. During the same period patient was treated with ACETYLSALICYLIC ACID SRT. Patient recovered.

Ibuhexal Side Effects Report #5325330-0
IBUHEXAL problem was reported by a Physician from GERMANY on Apr 26, 2007. Male patient, 36 years of age, weighting 242.5 lb, was diagnosed with pharyngolaryngeal pain and was treated with IBUHEXAL. After drug was administered, patient experienced the following problems/side effects: brain hypoxia, laryngeal oedema, respiratory failure, resuscitation. IBUHEXAL dosage: unknown. During the same period patient was treated with WICK MEDINAIT, MALLEBRIN. Patient died on 04/09/2007.


Ibuhexal Side Effects Report #5286970-0
Consumer or non-health professional from GERMANY reported IBUHEXAL problem on Mar 26, 2007. Female patient was diagnosed with back pain, hypertension and was treated with IBUHEXAL. After drug was administered, patient experienced the following problems/side effects: pain, suffocation feeling, swelling face, weight increased. IBUHEXAL dosage: unknown. During the same period patient was treated with ENAHEXAL. Patient recovered.


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