The FDA Find Bits Of Trash In Genzyme Drugs
Posted on: Saturday, 14 November 2009, 07:10 CST
The FDA has found garbage floating around in vials of drugs made by Genzyme, the agency warned doctors today.
The FDA said on Friday that bits of steel and rubber were found in drugs made by Genzyme used to treat rare enzyme disorders, saying it could cause serious adverse health effects for patients.
The news sent Genzyme shares plunging 8% soon after the FDA posted a warning to doctors on its web site. The stock has since recovered somewhat and is now down 5% to $50.09.
The products will remain on the market, despite those problems, because there are few alternative treatments.
FDA regulators said doctors should return the product to Genzyme if they suspect contamination. Physicians should also watch for allergic reactions such as blood clots and other problems.
Shares of Genzyme Corp. dropped $4.17, or 7.8 percent, to $49 in afternoon trading.
The drugs affected include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.
Dr Jason Woo, FDA's associate director of medical affairs, says, "We have worked continuously with Genzyme to ensure the continued availability of safe and effective products to meet the medical needs of patients with rare medical disorders."
Genzyme specializes in biotech drugs to treat rare diseases.
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On the Net:
Source: RedOrbit Staff & Wire Reports
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User Comments (1)
| 1. |
Posted by biotech guy on 11/17/2009, 15:26 This is truly a bit of muckraking as others have suggested. No one seems to want to do anything other than repeat what others of reported. Is that even ethical? Why aren't reporters digging a little deeper into this story? Why has the FDA chosen to leak information it has held on to for more than 10 years? Why are they reporting that the particulates found are >1% of manufactured lots when the numbers are closer to >0.01%? This smacks not only of sensationalism, but also poor journalism. Did you know that the former Director of Quality from the Genzyme Plant is now the VP of Manufacturing at Shire Pharmaceuticals? Why is it then, that now, after decades of "not taking sides" between pharmaceutical brands, the FDA advocates (yes, outright recommendation) for Shire drugs which compete with Genzyme markets to be approved without clinical trials? Does that sound safe or even positive for the industry? It smells of corruption and dirty politics to me. That is very well the probable source of this "trash" your so-called journalists allude to. |
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