Glaxo sees two drugs seized in US
The US Food and Drug Administration (FDA) has seized batches of two GlaxoSmithKline drugs, because of concerns over manufacturing quality
In a statement, the FDA
said the two drugs affected were diabetes tablets Avandamet and the slow-release
anti-depressant Paxil CR.
The FDA said the two products failed to meet standards for safety, strength,
quality and purity.
Yet it added that it did not believe they posed a health hazard.
Patients who are taking either medication have been advised to continue to do
so, but also talk to their doctor about the possibility of using alternative
products until the manufacturing problems are corrected.
Shares down
The FDA said that the Paxil CR tablets could split apart, leaving a person with
part of a tablet that did not contain the active ingredient.
And the Avandamet tablets did not have an accurate dose of their active
ingredient, it said.
"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.
Glaxo said it was working to resolve manufacturing problems as quickly as
possible.
Yet it added that both drugs would be in short supply in the United States in
the short term. UK-based Glaxo saw its shares closed down 2.2% in London
following the FDA announcement.
A spokesman for the company said it was too early to assess the financial impact
of the seizures.