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FDA seizes diabetes, antidepressant drugs Agency concerned about manufacturing quality
Friday, March 4, 2005 Posted: 2:05 PM EST (1905 GMT)
WASHINGTON (Reuters) -- The U.S. Food and Drug Administration said Friday that officials had seized batches of GlaxoSmithKline Plc's diabetes drug Avandamet and the controlled-release antidepressant Paxil CR because of concerns over manufacturing quality.
The FDA said in a statement that the manufacturing practices for the two drugs failed to meet standards for safety, strength, quality and purity.
However, the agency said it was not aware of any harm to consumers and did not believe there was a significant health hazard.
Patients taking the two drugs were advised to continue taking their medication but talk to their doctor about possibly using alternative products until the manufacturing problems have been corrected.
"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John Taylor, FDA Associate Commissioner for Regulatory Affairs.
There was no immediate comment from GlaxoSmithKline.