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Manufacturing problems lead to seizure of GSK drugs

07-Mar-2005

GlaxoSmithKline has become the latest drugmaker to fall foul of regulatory authorities for failing to meet manufacturing standards.

Just as contamination problems at Chiron's manufacturing plant in Liverpool cut into supplies of flu vaccine this winter, patients may also see short-term shortages of two GSK drugs, after US Food and Drug Administration (FDA) officials seized them from three company facilities on Friday.

The FDA said that the drug company failed to meet Good Manufacturing Practice (GMP) standards that ensure 'product safety, strength, quality and purity' when producing Paxil CR (paroxetine), an antidepressant, and GSK's combination diabetes treatment Avandamet (rosiglitazone and metformin). Officials seized the drugs from a distribution facility in the US, and a manufacturing plant and distribution facility in Puerto Rico.

"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, in a statement.

Among the violations noted by the FDA was the finding that the Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets did not have an accurate dose of rosiglitazone.

GSK said it has identified the cause of the Avandamet problem, and initiated a full inspection of Paxil CR, butr wouldnot be drawn on when the issues would be resolved.

The uk-headquartered company recalled some batches of the two products last month, and alerted doctors to the problem. But the FDA said that failure to recall all of the affected batches led to the manufacturing license suspension.

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