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FDA
Failed to Inspect Chinese Maker of Heparin Ingredient Linked to
Deaths; House Democrat Calls for FDA Commissioner's Resignation |
February
18, 2008--The US FDA said use
of heparin in multi-dose vials made by Baxter International had been
tied to life-threatening side effects, and four patients taking the
drug died. The Chinese plant that makes the heparin ingredient tied
to the adverse effects was not inspected by US regulators due to a
records mix-up. Authorities are urging doctors to use non-Baxter
vials of heparin. Heparin generates about $30 million in annual
sales for Baxter, which had about half the US market. Bloomberg.com
See
also: In the wake of the
heparin problems, Rep. Bart Stupak (D-Mich.) said FDA Commissioner
Andrew C. von Eschenbach should resign. Stupak has also alleged that
the FDA approved Sanofi-Aventis’ antibiotic Ketek (telithromycin)
despite knowledge that a key safety study of the drug was plagued by
faulty data; Ketek was linked to death and liver failure in 2006.
AP/Los
Angeles Times (2/15)
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Genstruct: Patience, Persistence, and Payoff
By John Russell |
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Finding the right business model for systems biology (SB) technology providers has been challenging — that’s hardly a new theme in biotech.
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