[e-drug] Glaxo GMP problems in USA; FDA bans distribution

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: Glaxo GMP problems in USA; FDA bans distribution
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[Another lesson that GMP inspection is also very needed for big farma in the developed world! Copied as fair use. From the Wall Street Journal. WB]

FDA Stops Distribution of Two Glaxo Drugs

*A *WALL STREET JOURNAL ONLINE* NEWS ROUNDUP*
March 4, 2005 5:08 p.m.

*GlaxoSmithKline* said Friday that the Food and Drug Administration has
halted distribution of two of its drugs  Paxil and Avandamet  as U.S.
marshals seized remaining batches of the drugs because of continued
violations at the pharmaceutical giant's manufacturing plants.

The FDA said, however, that it doesn't believe the products pose a
significant health hazard, and it urged patients who use the drugs to
continue taking them.

Shares of Glaxo fell $1.59, or 3.2%, to $48.91 in trading Friday on the
New York Stock Exchange.

Glaxo said the FDA action applies to all strengths of depression and
panic-disorder drug Paxil CR (12.5 mg, 25 mg, and 37.5 mg), as well as
all strengths of Type II-diabetes drug Avandamet (1 mg, 2 mg, and 4 mg).

The FDA said lots of both Paxil and Avandamet were confiscated from the
British company's plants in Puerto Rico and Tennessee.

"Manufacturing practices for the two drugs  failed to meet the
standards laid out by FDA that ensure product safety, strength, quality
and purity," the FDA said in a statement. Glaxo had voluntarily recalled
some of the affected lots of these products, but hadn't recalled all of
the affected lots. "This failure on the part of GSK resulted in today's
seizures by federal authorities," the statement said.

Among the violations found in the FDA's latest inspection, the statement
said, were that Paxil CR tablets could split apart, which would mean
that 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."

The FDA also found that Avandamet tablets didn't have an "accurate dose"
of rosiglitazone, which is one of the drug's active ingredients.

Neither the company nor the FDA believe that consumers were hurt by the
drugs, according to statements from both. The FDA added, however, that
patients on the drug should speak to their doctors about switching to
alternative drugs until the manufacturing problems are corrected.

The FDA said patients taking Paxil CR and Avandamet should continue
taking the drugs until they speak to their doctors. "The agency is
concerned that GSK's violation of manufacturing standards may have
resulted in the production of poor-quality drug products that could
potentially pose risks to consumers," the FDA said.

Glaxo said that it is working with the FDA to resolve these issues as
quickly as possible.

*Write to* the Online Journal's editors at newseditors@wsj.com