(Source-Reuters)
NEW YORK (Reuters) - The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television's 60 Minutes program.
The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients.
It had been given to as many as a third of all heart bypass patients in the United States at the height of its use over a period of many years, according to the report.
He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.
Showing posts with label recall. Show all posts
Showing posts with label recall. Show all posts
Monday, February 18, 2008
Monday, December 17, 2007
US-Made Child Meningitis Vaccine Recalled in China
(Full Story)
Over 100,000 doses of US-made vaccines for childhood meningitis have been recalled in China due to sterilisation concerns, the Chinese government said.
US pharmaceutical firm Merck and its China importer have recalled 104,930 doses of the vaccine as Merck cannot assure their sterility, the State Food and Drug Administration said in a statement posted on its website Sunday.
It came, however, amid US concerns surrounding a host of Chinese products ranging from fake drugs and toxic seafood to dangerous toys and substandard tyres.
Over 100,000 doses of US-made vaccines for childhood meningitis have been recalled in China due to sterilisation concerns, the Chinese government said.
US pharmaceutical firm Merck and its China importer have recalled 104,930 doses of the vaccine as Merck cannot assure their sterility, the State Food and Drug Administration said in a statement posted on its website Sunday.
It came, however, amid US concerns surrounding a host of Chinese products ranging from fake drugs and toxic seafood to dangerous toys and substandard tyres.
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