FDA Seizes Paxil, Avandamet Tablets

Patients Should Discuss Alternatives With Their Doctor

By Miranda Hitti
WebMD Medical News Reviewed By Michael Smith, MD
on Wednesday, March 09, 2005

March 9, 2005 -- U.S. marshals have seized tablets of the
antidepressant Paxil CR and the diabetes drug Avandamet from several
facilities because of manufacturing problems, the FDA says.

However, the FDA says in a news release that it does not believe there
is any significant danger to patients taking either drug. The FDA urges
patients to keep taking the drugs and to discuss alternatives with
their doctors until the problem is cleared up.

Paxil is used to treat depression and panic disorder. Avandamet is
prescribed for diabetes. Only the long-acting version of Paxil - called
Paxil CR -- is affected by this seizure. The immediate- release form -
called simply Paxil -- is not affected.

Manufacturing practices for the two drugs failed to meet FDA standards
for product safety, strength, quality, and purity, says the FDA. The
manufacturer, GlaxoSmithKline, has voluntarily recalled some of the
affected products but not all of them, prompting today's seizures, says
the FDA.

The seizures took place at GlaxoSmithKline's plant in Cidra, Puerto
Rico, and at distribution facilities in Puerto Rico and Knoxville,
Tenn.

"FDA and the Department of Justice will not allow drug manufacturers to
ignore our high public health standards for drug manufacturing," says
John M. Taylor, FDA associate commissioner for regulatory affairs.

"Once we discover a company is not following the standards, which were
created to ensure safety and quality, we expect them to correct the
deficiencies in an expedited manner. American consumers deserve the
best health care products on the market today, and companies that are
not adhering to these standards cannot assure FDA and American
consumers of the quality of their products."

"FDA has determined that neither product is medically necessary and
that alternative products are available for consumer use," says the FDA
statement.

The FDA says it's concerned that GlaxoSmithKline's violation of
manufacturing standards may have resulted in the production of
poor-quality drug products that could potentially pose risks to
consumers.

Among the violations noted during the FDA's latest inspection was the
finding that the Paxil CR tablets could split apart. That could leave
patients with a portion of the tablets lacking any active ingredient.
Or patients might receive part of a tablet that contains active
ingredient but lacks the intended controlled-release effect.

The FDA also says some Avandamet tablets did not have an accurate dose
of rosiglitazone, an active ingredient in the drug. Avandamet is a
combination of two diabetes medications, rosiglitazone and metformin.


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SOURCE: News release, FDA.