http://www.attorneyatlaw.com/2009/11/pi ... fda-warns/Pieces of Metal, Plastic, Other Trash Found in Genzyme Drugs, FDA WarnsFive drug products made by Genzyme Corp. and used to treat a variety of life-threatening diseases may be contaminated with tiny fragments of stainless steel, plastic, and other foreign materials that pose a risk of serious injury and death to patients, the Food and Drug Administration said.
The FDA warning issued today covers all lots beginning with “A” of the following Genzyme drugs:
• Cerezyme (imiglucerase) an intravenous (IV) infusion for treatment of Gaucher disease
• Fabrazyme (agalsidase beta) IV infusion for treatment of Fabry disease
• Myozyme (alglucosidase alpha) IV infusion for treatment of Pompe disease
• Aldurazyme (laronidase) IV infusion for treatment of Mucoploysaccharidosis Type I
• Thyrogen (thyrotropin alpha) intramuscular injection used as an adjunctive diagnostic tool and treatment for thyroid cancer
No Injuries Reported, Yet
Less than one percent of the lots of the drugs may be contaminated with the foreign particles and there have been no reports of patients suffering adverse health events as a result of receiving the contaminated drugs, the FDA said. However, the risk of life-threatening complications associated with use of the contaminated drugs prompted the FDA to issue its warning.
Stainless steel fragments, pieces of non-latex rubber from the vial stopper, and a fibrous material used in the manufacturing process have been detected in some bottles of the drugs, the FDA said.
The FDA is still investigating to determine how the contamination occurred. In the meantime, the agency is advising health care professionals to conduct a careful visual inspection of vials of the drugs for the presence of foreign materials before administering them. Also, patients given the drugs should be closely monitored for signs of adverse reactions to potentially contaminated products, the FDA said
http://www.attorneyatlaw.com/2009/11/pi ... fda-warns/
