Observed adverse reactions in the Phase 1/2 study and the open-label treatment period for the extension study following the controlled study were not different in nature or intensity.

The safety profile of Fabrazyme in pediatric Fabry disease patients, ages 8 to 16 years, was found to be consistent with that seen in adults [see   Use in Specific Populations (8.4) and Clinical Studies (14) ] .  The safety of Fabrazyme in patients younger than 8 years of age has not been eva luated.

Table 2 - Summary of Adverse Reactions (regardless of relationship) Occurring in Fabrazyme®-Treated Patients at an Incidence Greater than 2.5% Compared to Placebo-Treated Patients  MedDRA System Organ Class/ Preferred Term  Fabrazyme® n=80 (%)  Placebo n=60 (%) 
Cardiac Disorders 
Tachycardia 7 (9) 2 (3)
Ventricular wall thickening 4 (5) 1 (2)
Ear and Labyrinth Disorders 
Tinnitus 6 (8) 2 (3)
Hypoacusis 4 (5) 0
Gastrointestinal Disorders 
Toothache 5 (6) 2 (3)
Dry mouth 3 (4) 0
General Disorders and Administration Site Conditions 
Chills 34 (43) 7 (12)
Pyrexia 31 (39) 13 (22)
Fatigue 19 (24) 10 (17)
Edema peripheral 17 (21) 4 (7)
Pain 13 (16) 8 (13)
Feeling cold 9 (11) 1 (2)
Adverse event 8 (10) 3 (5)
Chest discomfort 4 (5) 1 (2)
Infections and Infestations 
Upper respiratory tract infection  35 (44) 18 (30)
Lower respiratory tract infection  14 (18) 4 (7)
Sinusitis 7 (9) 2 (3)
Pharyngitis 5 (6) 1 (2)
Fungal infection 4 (5) 0
Viral infection 4 (5) 0
Localized infection 3 (4) 0
Injury, Poisoning and Procedural Complications 
Procedural pain 20 (25) 12 (20)
Post-procedural complication  8 (10) 1 (2)
Excoriation 7 (9) 1 (2)
Fall 5 (6) 2 (3)
Contusion 3 (4) 0
Thermal burn 3 (4) 0
Investigations 
Blood creatinine increased 7 (9) 3 (5)
Musculoskeletal and Connective Tissue Disorders 
Pain in extremity 15 (19) 5 (8)
Back pain 13 (16) 6 (10)
Myalgia 11 (14) 3 (5)
Muscle spasms 4 (5) 1 (2)
Nervous System Disorders 
Headache 31 (39) 17 (28)
Paresthesia 25 (31) 11 (18)
Dizziness 17 (21) 5 (8)
Burning sensation 5 (6) 0
Psychiatric Disorders 
Anxiety 5 (6) 2 (3)
Depression 5 (6) 1 (2)
Respiratory, Thoracic and Mediastinal Disorders 
Cough 26 (33) 15 (25)
Nasal congestion 15 (19) 9 (15)
Dyspnea 6 (8) 1 (2)
Respiratory tract congestion 6 (8) 1 (2)
Wheezing 5 (6) 0
Skin and Subcutaneous Tissue Disorders 
Rash 16 (20) 6 (10)
Pruritus 8 (10) 2 (3)
Vascular Disorders 
Hypertension 11 (14) 3 (5)
Hot flush 4 (5) 0

Ninety-five of 121 (79%) adult patients and 11 of 16 (69%) pediatric patients (106 of 137, 74% of all patients) treated with Fabrazyme in clinical studies have developed IgG antibodies to Fabrazyme.  Most patients who develop IgG antibodies do so within the first three months of exposure.  IgG seroconversion in pediatric patients was associated with prolonged half-life of Fabrazyme, a phenomenon rarely observed in adult patients [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.4) ].  A possible cause for this prolongation likely pertains to the ability of antibodies to act as “carriers” for their antigens.  Among t