Genzyme just can't seem to catch a break. Vials of five of its meds for rare diseases may be tainted with bits of rubber, steel, or foreign fibers, the FDA said. And while the contamination doesn't seem to be widespread, it does raise more questions about quality control at the company. Genzyme has only just finished ramping up production after viral contamination shut down an entire plant.
The contaminated vials contained the two meds affected by the viral contamination--Cerezyme for Gaucher disease and Fabrazyme for Fabry disease--as well as Myozyme, a treatment for Pompe disease; Aldurazyme for mucopolysaccharidosis; and Thyrogen, a thyroid cancer drug. FDA says the steel and fiber was introduced at Genzyme's Boston factory, where all five drugs are put into vials, the New York Times reports. The rubber fragments' source is the stoppers on those vials.
But FDA isn't recalling the drugs, saying that the supply of these rare-disease remedies is critical. The agency had to hustle an alternative to Cerezyme to the market to help combat a shortage caused by the previous manufacturing problems. So the agency has alerted healthcare professionals to visually inspect the vials and take other measures to ensure safety.
Genzyme says it hasn't received any adverse-event reports related to the contamination, and that the the rate of contamination--an estimated 1 percent at this point--is about the same as it has been historically.
- see the release from Genzyme
- read the FDA news
- get more from the FDA's information for healthcare professionals
- read the news from Reuters
- check out the NYT story