Aldurazyme and catheter related complication Patient Reports February 12, 2012

Aldurazyme Side Effects Report #5390951-6
Aldurazyme side effect was reported by a Consumer or non-health professional from UNITED STATES on Feb 13, 2007. Female patient, 14 years of age, weighting 70.33 lb, was diagnosed with mucopolysaccharidosis ih and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: catheter related complication, deep vein thrombosis , peripheral coldness, pollakiuria, pyrexia, skin discolouration, urinary tract disorder. Aldurazyme dosage: 17.4 MG QWK IV. Patient recovered.

Aldurazyme Side Effects Report #5676551-9
Aldurazyme side effect was reported by a Physician from COLOMBIA on Mar 04, 2008. Male patient, child 6 years of age, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: catheter related complication, pneumonia bacterial. Aldurazyme dosage: 0.51 MG/KG, 1X/W, INTRAVENOUS. During the same period patient was treated with LEVOTHYROXINE. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #6081440-4
Aldurazyme side effect was reported by a Physician from UNITED STATES on Feb 05, 2009. Female patient, child 6 years of age, weighting 40.12 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: asthenia, bradycardia, cardio-respiratory arrest, catheter related complication, cough, dyspnoea, hydrocephalus , hypoxia, infusion site oedema. Aldurazyme dosage: 8.7 MG, 1X/W, INTRAVENOUS. During the same period patient was treated with DIPHENHYDRAMINE, ACETAMINOPHNE, HEPARIN. Patient died.

Aldurazyme Side Effects Report #5390992-9
Aldurazyme side effect was reported by a Health Professional from UNITED STATES on Apr 25, 2006. Female patient, child 3 years of age, weighting 29.10 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, catheter related complication, hyperglycaemia, hypertension, upper respiratory tract infection. Aldurazyme dosage: 8.7 MG QWK IV. Patient was hospitalized. Patient recovered.


Aldurazyme Side Effects Report #4971734-5
Aldurazyme side effect was reported by a Consumer or non-health professional from UNITED STATES on Mar 23, 2006. Female patient, child 3 years of age, weighting 29.10 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: catheter related complication, crying, hydrocephalus , pneumonia . Aldurazyme dosage: 8.7 MG QWK IV. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #4971736-9
Aldurazyme side effect was reported by a Consumer or non-health professional from UNITED STATES on Mar 23, 2006. Female patient, child 3 years of age, weighting 29.10 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: acidosis, catheter related complication, central nervous system infection, cyanosis, device occlusion, heart rate increased, hydrocephalus , hyperglycaemia, pneumonia . Aldurazyme dosage: 8.7 MG QWK IV. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #5390963-2
Aldurazyme side effect was reported by a Physician from UNITED STATES on Apr 24, 2007. Male patient, 14 years of age, weighting 59.75 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: blood pressure increased, c-reactive protein decreased, catheter related complication, infusion related reaction, international normalised ratio increased, protein total abnormal, prothrombin level increased, subclavian vein thrombosis, thrombin-antithrombin iii complex abnormal. Aldurazyme dosage: 15.7 MG QWK IV. During the same period patient was treated with ALBUTEROL, EAR DROPS, MIRALAX, ADVAIR DISKUS, FLONASE. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #5390976-0
Aldurazyme side effect was reported by a Health Professional from UNITED STATES on Mar 09, 2007. Female patient, 14 years of age, weighting 66.14 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: catheter related complication, catheter site haematoma. Aldurazyme dosage: 17.4 MG QWK IV. Patient recovered.

Aldurazyme Side Effects Report #6000626-8
Aldurazyme side effect was reported by a Consumer or non-health professional from COLOMBIA on Nov 27, 2008. Male patient, child 7 years of age, weighting 36.38 lb, was diagnosed with mucopolysaccharidosis and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: catheter related complication, pneumonia . Aldurazyme dosage: 0.51 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with LEVOTHYROXINE, MUCOPOLYSACCHARIDOSIS. Patient was hospitalized. Patient recovered.


Aldurazyme Side Effects Report #6071856-4
Aldurazyme side effect was reported by a Health Professional from UNITED STATES on Jan 23, 2009. Female patient, child 6 years of age, weighting 30.42 lb, was diagnosed with mucopolysaccharidosis and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: asthenia, catheter related complication, catheter site swelling, dyspnoea, hydrocephalus , hypoxia, pneumonia , respiratory arrest, respiratory distress. Aldurazyme dosage: 8.6 MG, 1X/W, INTRAVENOUS. During the same period patient was treated with DIPHENHYDRAMINE, ACETAMINOPHEN, HEPARIN. Patient died.