Aldurazyme and cardio-respiratory arrest Patient Reports February 12, 2012

Aldurazyme Side Effects Report #4592662-3
Aldurazyme side effect was reported by a Physician from on Feb 04, 2005. Female patient, child 9 years of age, was diagnosed with mucopolysaccharidosis ih/s and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardiac failure congestive, cardio-respiratory arrest, chest pain , hypertension, hypertrophic cardiomyopathy, infusion related reaction, intercostal retraction, loss of consciousness, mitral valve incompetence. Aldurazyme dosage: 0.58 MG/KG QWK, IV. Patient was hospitalized. Patient died on 02/03/2005.

Aldurazyme Side Effects Report #4666356-X
Aldurazyme side effect was reported by a Health Professional from on Apr 26, 2005. Female patient, 31 years of age, weighting 77.16 lb, was diagnosed with mucopolysaccharidosis ih and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, convulsion, poor venous access. Aldurazyme dosage: unknown. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #5390216-2
Aldurazyme side effect was reported by a Physician from MEXICO on Oct 19, 2006. Male patient, child 9 years of age, weighting 55.12 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, nervous system disorder, procedural complication. Aldurazyme dosage: 14.4 MG IV. During the same period patient was treated with DIPHENHYDRAMINE. Patient died on 10/21/2006.

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 #4848746-5
Aldurazyme side effect was reported by a Physician from SPAIN on Oct 11, 2005. 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: acute respiratory failure, bradycardia, cardio-respiratory arrest, cardiopulmonary failure, cyanosis. Aldurazyme dosage: unknown. During the same period patient was treated with SALBUTAMOL, CEFTAXIMA, URBASON. Patient died on 04/29/2004.

Aldurazyme Side Effects Report #5925563-6
Aldurazyme side effect was reported by a Physician from BRAZIL on Oct 04, 2008. Male patient, child 4 years of age, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, no therapeutic response, obstructive airways disorder, pneumonia , respiratory disorder. Aldurazyme dosage: 1.2 MG/KG, QW; INTRAVENOUS; 0.58 MG/KG, QW; INTRAVENOUS. Patient died on 06/01/2007.

Aldurazyme Side Effects Report #4680238-9
Aldurazyme side effect was reported by a Physician from on May 11, 2005. Female patient, 31 years of age, weighting 77.16 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, convulsion, poor venous access, procedural complication. Aldurazyme dosage: unknown. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #5390919-X
Aldurazyme side effect was reported by a Consumer or non-health professional from UNITED STATES on Dec 20, 2004. Male patient, 23 years of age, weighting 88.18 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, fall , pallor, treatment noncompliance, ventricular fibrillation. Aldurazyme dosage: 0.58 MG/KG QWK IV. Patient died on 07/30/2004.

Aldurazyme Side Effects Report #5424868-5
Aldurazyme side effect was reported by a Health Professional from UNITED STATES on Aug 09, 2007. Female patient, 20 years of age, weighting 82.23 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: back pain , cardio-respiratory arrest, convulsion. Aldurazyme dosage: 23.2 MG QWK IV. Patient was hospitalized. Patient recovered.


Aldurazyme Side Effects Report #5450879-X
Aldurazyme side effect was reported by a Health Professional from UNITED STATES on Aug 28, 2007. Female patient, 20 years of age, weighting 82.23 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: anaphylactic reaction, bronchospasm, cardio-respiratory arrest, cardiomegaly, convulsion, eyelid oedema, hypokalaemia, joint range of motion decreased, local swelling. Aldurazyme dosage: 23.2 MG QWK IV. During the same period patient was treated with CARDIZEM, MOTRIN MFR. Patient was hospitalized. Patient recovered.

Aldurazyme Side Effects Report #5389803-7
Aldurazyme side effect was reported by a Physician from JAPAN on Mar 04, 2007. Female patient, 15 years of age, weighting 46.30 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest. Aldurazyme dosage: 14.5 MG QWK IV. During the same period patient was treated with CARBOCYSTEINE, HYDROXYZINE PAMOATE. Patient died on 03/03/2007.

Aldurazyme Side Effects Report #5506450-4
Aldurazyme side effect was reported by a Physician from JAPAN on Oct 24, 2007. Female patient, 15 years of age, weighting 46.30 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: aortic valve disease, cardiac failure congestive, cardio-respiratory arrest, mitral valve disease, white blood cell count increased. Aldurazyme dosage: 14.5 MG QWK IV. During the same period patient was treated with CARBOCYSTEINE, HYDROXYZINE PAMOATE. Patient died on 03/03/2007.

Aldurazyme Side Effects Report #5594006-7
Aldurazyme side effect was reported by a Physician from JAPAN on Nov 15, 2007. Female patient, 15 years of age, weighting 46.30 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, histology abnormal. Aldurazyme dosage: 14.5 MG, QW, INTRAVENOUS. During the same period patient was treated with CARBOCYSTEINE, HYDROXYZINE PAMOATE. Patient died on 03/04/2007.

Aldurazyme Side Effects Report #5361342-9
Aldurazyme side effect was reported by a Physician from SPAIN on May 30, 2007. Male patient, child 1 years of age, weighting 22.05 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, pneumonia , respiratory distress. Aldurazyme dosage: unknown. Patient died on 05/20/2007.


Aldurazyme Side Effects Report #5928905-0
Aldurazyme side effect was reported by a Physician from POLAND on Oct 07, 2008. Female patient, child 1 years of age, weighting 19.84 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, cardiopulmonary failure. Aldurazyme dosage: unknown. Patient died on 03/12/2008.

Aldurazyme Side Effects Report #5603252-5
Aldurazyme side effect was reported by a Physician from BRAZIL on Jan 07, 2008. Male patient was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, ear infection , no therapeutic response, refusal of treatment by relative, respiratory disorder, respiratory failure, sinusitis . Aldurazyme dosage: 1.2 MG/KG, QW, INTRAVENOUS; 0.58 MG/KG, QW, INTRAVENOUS. Patient was hospitalized. Patient died on 06/01/2007.

Aldurazyme Side Effects Report #6036412-2
Aldurazyme side effect was reported by a Health Professional from UNITED STATES on Dec 29, 2008. Female patient, weighting 24.69 lb, was diagnosed with mucopolysaccharidosis i and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardio-respiratory arrest, hepatic function abnormal, oedema, respiratory distress, stem cell transplant, transplant rejection, venoocclusive disease. Aldurazyme dosage: 0.58 MG/KG, 1X/W. Patient died on 12/27/2008.

Aldurazyme Side Effects Report #5776069-9
Aldurazyme side effect was reported by a Physician from PORTUGAL on May 30, 2008. Female patient, 18 years of age, weighting 70.55 lb, was diagnosed with mucopolysaccharidosis and was treated with Aldurazyme. After drug was administered, patient experienced the following side effects: cardiac failure, cardio-respiratory arrest, disease progression, pulmonary hypertension , respiratory failure. Aldurazyme dosage: unknown. During the same period patient was treated with FUROSEMIDE, ESPIRONOLACTONA. Patient died on 05/23/2008.