"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Patients and their caregivers should be informed that a registry for patients with Pompe disease (the Pompe Registry) has been established in order to better understand the variability and progression of Pompe disease and to continue to monitor and evaluate long-term treatment effects of alglucosidase alfa. The Pompe Registry will also monitor the effects of alglucosidase alfa on pregnant women and their offspring [see Use in Specific Populations]. Patients and their caregivers are encouraged to participate in the Pompe Registry and should be advised that their participation is voluntary and may involve long-term follow-up. For information regarding the registry program visit www.pomperegistry.com or call 1-800-745-4447.
General Clinical Recommendations
Patients and caregivers should be informed that anaphylactic reactions, severe allergic reactions, and immune mediated reactions have been observed in some patients having received MYOZYME infusions. Patients and caregivers should also be warned of the risk for acute cardiorespiratory failure, cardiac arrhythmias, and infusion reactions [see BOXED WARNING and WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 6/4/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Myozyme Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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