Myozyme and dysphagia Patient Reports February 13, 2012

Myozyme Side Effects Report #5940267-1
Myozyme side effect was reported by a Physician from FRANCE on Oct 21, 2008. Female patient, 73 years of age, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, bradycardia, bronchitis , cough, cyanosis, dysphagia, electrocardiogram abnormal, hypotension, tachypnoea. Myozyme dosage: unknown. During the same period patient was treated with TAMSULOSIN. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #6060121-7
Myozyme side effect was reported by a Physician from FRANCE on Jan 15, 2009. Female patient, 73 years of age, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, acute respiratory failure, bradycardia, bronchitis , disease complication, dysphagia, heart sounds abnormal, hypotension. Myozyme dosage: unknown. During the same period patient was treated with TAMSULOSIN, AUGMENTIN, ANTIBIOTICS. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5860760-X
Myozyme side effect was reported by a Health Professional from UNITED STATES on Aug 13, 2008. Male patient, 66 years of age, weighting 189.2 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: asthenia, dysphagia, hypothyroidism, mastication disorder, movement disorder , somnolence. Myozyme dosage: 20 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with COZAAR, NORVASC, INDAPAMIDE, ZOLOFT, THYROID SUPPLEMENT, POTASSIUM CHLORIDE, FISH OIL SUPPLEMENT, VITAMIN. Patient recovered.

Myozyme Side Effects Report #5897060-8
Myozyme side effect was reported by a Physician from UNITED STATES on Sept 10, 2008. Male patient, 66 years of age, weighting 189.2 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: blood potassium decreased, dysphagia, electrolyte imbalance, hypothyroidism, infusion related reaction, mastication disorder, movement disorder , somnolence. Myozyme dosage: 20 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with COZAAR, NORVASC, INDAPAMIDE, ZOLOFT, THYROID SUPPLEMENT, FISH OIL SUPPLEMENT, VITAMIN, POTASSIUM. Patient recovered.


Myozyme Side Effects Report #5909597-3
Myozyme side effect was reported by a Health Professional from UNITED STATES on Sept 26, 2008. Male patient, 66 years of age, weighting 189.2 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: asthenia, blood potassium decreased, condition aggravated, dysphagia, feeling abnormal, hypothyroidism, mastication disorder, mobility decreased, paralysis . Myozyme dosage: 20 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with COZAAR, NORVASC, INDAPAMIDE, ZOLOFT, THYROID SUPPLEMENT, POTASSIUM, FISH OIL SUPPLEMENT, VITAMIN. Patient recovered.

Myozyme Side Effects Report #6003463-3
Myozyme side effect was reported by a Physician from AUSTRALIA on June 03, 2008. Female patient, 63 years of age, weighting 132.3 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: disease progression, dysphagia, feeding disorder, mobility decreased, motor dysfunction, pneumonia aspiration. Myozyme dosage: 20 MG/KG, Q2W, INTRAVENOUS. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5285778-X
Myozyme side effect was reported by a Health Professional from UNITED STATES on Nov 21, 2006. Female patient, 60 years of age, weighting 160.9 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: dysphagia, meniscus lesion, oedema peripheral, synovial cyst. Myozyme dosage: unknown. Patient recovered.

Myozyme Side Effects Report #5454997-1
Myozyme side effect was reported by a Physician from AUSTRALIA on Aug 30, 2007. Female patient, child 3 years of age, weighting 33.73 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: blood creatine phosphokinase increased, diarrhoea, dysphagia, fall , fatigue, muscular weakness. Myozyme dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with ALPHA. Patient recovered.

Myozyme Side Effects Report #5533877-7
Myozyme side effect was reported by a Physician from ITALY on Nov 14, 2007. Male patient, child 10 years of age, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: dysphagia, erythema, infusion related reaction, throat tightness. Myozyme dosage: unknown. Patient recovered.


Myozyme Side Effects Report #5366201-3
Myozyme side effect was reported by a Health Professional from UNITED STATES on June 05, 2007. Male patient, child 1 years of age, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: abasia, aspiration, asthenia, atelectasis, blood immunoglobulin g increased, dysphagia, hypertension, hypertonia, hypoxia. Myozyme dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with ALPHA, CAPTOPRIL, STEROIDS. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5471080-X
Myozyme side effect was reported by a Health Professional from UNITED STATES on Sept 11, 2007. Female patient, child 1 years of age, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: dysphagia. Myozyme dosage: unknown. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5226048-5
Myozyme side effect was reported by a Physician from BRAZIL on Jan 15, 2007. Female patient, weighting 14.00 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: aspiration, bradycardia, choking , cough, dysphagia, fatigue, haematocrit decreased, heart rate decreased, hypotension. Myozyme dosage: 20 MG/KG IV. During the same period patient was treated with PROPRANOLOL, FERROUS SULPHATE, HYDROCORTISONE, HYDROXYZINE. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5331026-1
Myozyme side effect was reported by a Physician from GERMANY on May 03, 2007. Male patient, weighting 19.62 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: dysphagia, muscle disorder , myotonia, pneumonia aspiration. Myozyme dosage: 20 MG/LG Q2WKS IV. Patient died on 03/04/2007.

Myozyme Side Effects Report #5350978-7
Myozyme side effect was reported by a Health Professional from UNITED STATES on May 23, 2007. Male patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, aspiration, asthenia, atelectasis, dysphagia, hypertension, hypertonia, respiratory syncytial virus infection . Myozyme dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with ALPHA, CAPTOPRIL, STEROIDS. Patient was hospitalized. Patient recovered.


Myozyme Side Effects Report #5390882-1
Myozyme side effect was reported by a Health Professional from UNITED STATES on July 02, 2007. Male patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: abasia, aspiration, asthenia, atelectasis, blood immunoglobulin g increased, condition aggravated, disease progression, dysphagia, glycogen storage disease type ii. Myozyme dosage: 20 MG/KG Q2WKS IV. During the same period patient was treated with ALPHA, CAPTOPRIL, STEROIDS. Patient was hospitalized. Patient died on 06/30/2007.

Myozyme Side Effects Report #5534675-0
Myozyme side effect was reported by a Physician from UNITED STATES on Nov 16, 2007. Male patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: aspiration, catheter related infection, cleft palate, disease progression, disease recurrence, dysphagia, nystagmus, respiratory failure. Myozyme dosage: 40 MG/KG Q2WKS IV. During the same period patient was treated with RITUXIMAB, METHOTREXATE, IMMUNE GLOBULIN INTRAVENOUS, BENADRYL, TYLENOL. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5805198-6
Myozyme side effect was reported by a Physician from UNITED STATES on June 27, 2008. Male patient, weighting 14.77 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: cardiomegaly, dysphagia, hypotonia, influenza, otitis media, pneumonia aspiration, respiratory distress, respiratory syncytial virus infection . Myozyme dosage: 20 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with SYNAGIS. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #5894672-2
Myozyme side effect was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Sept 10, 2008. Female patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: aspiration, blood creatine phosphokinase increased, bradycardia, collapse of lung, dysphagia, dyspnoea, hepatomegaly, hypertrophic cardiomyopathy, hypotonia. Myozyme dosage: 40 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with CARVEDILOL, LASIX. Patient recovered.

Myozyme Side Effects Report #5909538-9
Myozyme side effect was reported by a Physician from JAPAN on Sept 18, 2008. Female patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: aspiration, dysphagia, respiratory disorder, respiratory failure, respiratory syncytial virus infection . Myozyme dosage: unknown. Patient recovered.


Myozyme Side Effects Report #6024986-7
Myozyme side effect was reported by a Physician from MEXICO on Dec 11, 2008. Male patient, weighting 14.33 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: blood creatine phosphokinase increased, blood culture positive, demyelination, dysphagia, pneumonia streptococcal, polyneuropathy. Myozyme dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, METAMIZOLE. Patient was hospitalized. Patient died on 11/29/2008.

Myozyme Side Effects Report #6053851-4
Myozyme side effect was reported by a Physician from UNITED STATES on Jan 16, 2009. Male patient, weighting 21.83 lb, was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: alpha haemolytic streptococcal infection, aspiration, blood pressure diastolic decreased, catheter related infection, cleft palate, disease progression, dysphagia, escherichia infection, heart rate increased. Myozyme dosage: 40 MG/KG, Q2Q, INTRAVENOUS 30 MG/KG, Q2W, INTRAVENOUS, 20 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with RITUXIMAB, METHOTREXATE, IMMUNE GLOBULIN INTRAVENOUS, BENADRYL, ACETAMINOPHEN, BUDESONIDE. Patient was hospitalized. Patient recovered.

Myozyme Side Effects Report #6130971-7
Myozyme side effect was reported by a Physician from UNITED ARAB EMIRATES on Mar 10, 2009. Male patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: disease progression, dysphagia, hypotonia. Myozyme dosage: 20 MG/KG, Q2W. Patient recovered.

Myozyme Side Effects Report #6131096-7
Myozyme side effect was reported by a Physician from UNITED ARAB EMIRATES on Mar 10, 2009. Male patient was diagnosed with glycogen storage disease type ii and was treated with Myozyme. After drug was administered, patient experienced the following side effects: agitation, blood immunoglobulin g increased, diarrhoea, dysphagia, erythema, hypotonia, infusion related reaction, lung infection. Myozyme dosage: 20 MG/KG, Q2W, INTRAVENOUS. During the same period patient was treated with STEROIDS, ACETAMINOPHEN, PREDNISOLONE, METHYLPREDNISOLONE, ANTIHISTAMINES, HYDROCORTISONE, ZANTAC. Patient was hospitalized. Patient recovered.