Orfadin and hypotonia Patient Reports February 12, 2012

Orfadin Side Effects Report #5266640-5
Orfadin side effect was reported by a Physician from ISRAEL on Feb 16, 2007. Male patient, child 8 years of age, weighting 49.00 lb, was diagnosed with tyrosinaemia and was treated with Orfadin. After drug was administered, patient experienced the following side effects: cyanosis, hypotonia, portal hypertension, scrotal swelling, varices oesophageal. Orfadin dosage: 20 MILLIGRAM A DAY; ORAL. Patient was hospitalized. Patient died on 03/17/2006.

Orfadin Side Effects Report #5989666-2
Orfadin side effect was reported by a Consumer or non-health professional from ISRAEL on May 30, 2006. Male patient, child 8 years of age, was diagnosed with tyrosinaemia and was treated with Orfadin. After drug was administered, patient experienced the following side effects: blood calcium decreased, blood sodium decreased, cardio-respiratory arrest, cyanosis, depressed level of consciousness, dyspnoea, hypotonia, portal hypertension, protein total decreased. Orfadin dosage: 1 MG/KG. Patient was hospitalized. Patient died.

Orfadin Side Effects Report #5213939-4
Orfadin side effect was reported by a Health Professional from CZECH REPUBLIC on Dec 22, 2006. Male patient, child 4 years of age, weighting 33.07 lb, was diagnosed with tyrosinaemia and was treated with Orfadin. After drug was administered, patient experienced the following side effects: acute polyneuropathy, gastroenteritis , hyporeflexia, hypotonia, myalgia, paraesthesia. Orfadin dosage: 5 MILLIGRAM THREE TIMES DAILY; ORAL. During the same period patient was treated with ASCORBIC ACID, VITAMIN E, MILUPA TYR, CALCIUM SUPP. Patient was hospitalized. Patient recovered.

Orfadin Side Effects Report #5073849-2
Orfadin side effect was reported by a Health Professional from CZECH REPUBLIC on July 13, 2006. Male patient, child 4 years of age, weighting 33.07 lb, was diagnosed with tyrosinaemia and was treated with Orfadin. After drug was administered, patient experienced the following side effects: abasia, electromyogram abnormal, gastroenteritis , hyporeflexia, hypotonia, myalgia, paraesthesia, polyneuropathy. Orfadin dosage: 5 MILLIGRAM THREE TIMES DAILY, ORAL. During the same period patient was treated with VITAMINE C, VITAMINE E, MILUPA TYR, CALCIUM SUPP. Patient was hospitalized. Patient recovered.


Orfadin Side Effects Report #5989265-2
Orfadin side effect was reported by a Consumer or non-health professional from CZECH REPUBLIC on July 13, 2006. Male patient, child 3 years of age, was diagnosed with tyrosinaemia and was treated with Orfadin. After drug was administered, patient experienced the following side effects: abasia, acute polyneuropathy, gastroenteritis , hyporeflexia, hypotonia, myalgia, paraesthesia. Orfadin dosage: 15 MG (5 MG,3 IN 1 D), ORAL. During the same period patient was treated with MILUPA TYR, CALCIUM, VITAMIN E, VITAMIN C. Patient was hospitalized. Patient recovered.