Biotech Values

[DewDiligence]

Here’s today’s FDA warning on Genzyme’s contamination problem. The
foreign matter includes stainless steel, rubber, and fiber-like material.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190400.htm

›Information for Healthcare Professionals - Potential Contamination of Products Manufactured by Genzyme Corporation, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen

[11-13-2009] FDA is warning healthcare professionals about the potential for foreign particle contamination of several products manufactured by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases. The foreign particles, believed to be found in less than 1% of products based on product lots assessed to date, include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients. This problem affects all lots of the below listed products which have the prefix "A" (e.g., Lot A12345).

The affected products include:

• Cerezyme (imiglucerase) for Gaucher disease – intravenous (IV) infusion

• Fabrazyme (agalsidase beta) for Fabry disease – IV infusion

• Myozyme (alglucosidase alpha) for Pompe disease – IV infusion

• Aldurazyme (laronidase) for Mucopolysaccharidosis Type I – IV infusion

• Thyrogen (thyrotropin alpha) used as an adjunctive diagnostic tool and treatment for thyroid cancer – Intramuscular (IM) injection

FDA was alerted to contaminated vials through product quality reports, which are required to be submitted by the manufacturer, in compliance with FDA's Current Good Manufacturing Practices. The FDA is actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation.

At this time, no adverse event reports attributed to foreign particle contamination have been received by FDA. However, healthcare professionals should be alert for the development of adverse events. Potential adverse events from IM administration of a contaminated product could include local pain, swelling, and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work.

Cerezyme, Fabrazyme, Myozyme, and Thyrogen are supplied as lyophilized powders requiring reconstitution before administration; Aldurazyme is supplied as a liquid solution.

The Agency is acutely aware of the critical need for patients to have continued access to these important products. In reaching its decision to allow these products to continue to be marketed, FDA has carefully considered the potential for serious adverse events from foreign particle contamination, the likelihood that the steps recommended below will significantly reduce the risk of administration of contaminated products, the lack of FDA-approved therapeutic alternatives for Cerezyme, Fabrazyme, Myozyme, and Aldurazyme, and the fact that levothyroxine withdrawal, an effective and well-established alternative for Thyrogen, may not be suitable for all patients.

To reduce the risk of administering a contaminated product, healthcare professionals should:

• Visually inspect the powder in the vial for the presence of particles, before reconstitution.

• Visually inspect the reconstituted powder (in solution) and the Aldurazyme solution for the presence of particles.

• Do not administer any product with visualized particles. The product should be returned to Genzyme Corporation (1-800-745-4447, option 2).

• Continue to use an in-line, low protein-binding 0.2 or 0.22 micrometer filter as recommended in the drug labeling for Cerezyme, Fabrazyme, Myozyme, and Aldurazyme. Note that at this time, FDA has not determined whether using an in-line, low protein-binding 0.2 or 0.22 micrometer filter will remove all foreign particles or whether foreign particles might affect the integrity of the in-line filter.

• Observe for local or systemic infusion reactions after administration.‹