Alerts
Genzyme Products including alglucosidase alfa (Myozyme), algasidase beta (Fabrazyme), imiglucerase (Cerezyme), laronidase (Aldurazyme), and thyrotropin alfa (Thyrogen) - Possible Particulate Matter Contamination
November 16, 2009
FDA and Genzyme are notifying healthcare providers about possible particulate contamination of alglucosidase alfa (Myozyme), algasidase beta (Fabrazyme), imiglucerase (Cerezyme), laronidase (Aldurazyme), and thyrotropin alfa (Thyrogen). The particulates range in size from 120 – 500 microns and may include stainless steel, non-latex rubber, and fiber-like matter from the manufacturing process. These particulates have been found in < 1% of the available products. However, the problem affects all lots of these products which begin with the prefix “A” (eg, Lot #A1111).
The particulates may reduce the efficacy of the affected products and could cause adverse events if administered to patients. Intramuscular administration could cause local pain, swelling, or inflammation. Intravenous administration could cause more serious adverse effects including blood vessel damage, embolism, anaphylaxis, or other immune-mediated reactions. At this time, no adverse events have been reported due to the presence of particulate matter.
These products are used for the treatment of rare, life-threatening diseases. No FDA-approved alternatives are available for these products, with the exception of levothyroxine withdrawal, which may be an alternative to thyrotropin alfa (Thyrogen) for some patients. Because patients must have continued access to these therapies, FDA has weighed the potential risks of recalling the products against the potential for injury from the affected products. Based on this, FDA has decided to allow the affected products to remain on the market. FDA will continue to investigate and correct the causes of the contamination.
Healthcare providers can reduce the risk of administering contaminated product by taking the following steps:
- Consider using levothyroxine withdrawal as an alternative to thyrotropin alfa (Thyrogen).
- Inspect products prior to use:
- Lyophilized powders (alglucosidase alfa [Myozyme], algasidase beta [Fabrazyme], imiglucerase [Cerezyme], and thyrotropin alfa [Thyrogen]): Visually inspect the vial for particles before reconstitution, and inspect the reconstituted solution for particles after preparation.
- Solution (laronidase [Aldurazyme]): Visually inspect the vial for particles.
- Avoid administering any product with visible particles. Call Genzyme at 800-745-4447 to arrange to return the product.
- During administration, filter solutions with an in-line, low protein-binding 0.2 or 0.22 micron filter as recommended for alglucosidase alfa (Myozyme), algasidase beta (Fabrazyme), imiglucerase (Cerezyme), and laronidase (Aldurazyme). It is unknown whether such filtration will remove all foreign particles, or whether the particles might affect the filter’s integrity.
- Monitor patients for adverse effects after administration.
- Educate patients to continue therapy as prescribed, and to report any adverse effects to their prescriber.
Additional information is available at the following links:
- Medwatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190480.htm - Information for HealthCare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm190400.htm - Dear Healthcare Professional Letters:
November 16, 2009; University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
