March 4, 2005U.S. Marshals Seize Lots of
GlaxoSmithKline's Paxil CR and Avandamet Tablets Because of
Continuing Good Manufacturing Practice Violations
In a response to ongoing concerns about manufacturing quality,
the Food and Drug Administration (FDA) and the Department of Justice
today initiated seizures of Paxil CR and Avandamet tablets
manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices
for the two drugs, approved to treat depression and panic disorder (Paxil
CR) and Type II Diabetes (Avandamet), failed to meet the standards
laid out by FDA that ensure product safety, strength, quality and
purity.
"FDA and the Department of Justice will not allow drug
manufacturers to ignore our high public health standards for drug
manufacturing," said 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 is not aware of any harm to consumers by the products subject
to this seizure and it does not believe that these products pose a
significant health hazard to consumers. Consequently, FDA urges
patients who use these two drugs to continue taking their tablets
and to talk with their health care provider about possible
alternative products for use until the manufacturing problems have
been corrected. FDA has determined that neither product is medically
necessary and that alternative products are available for consumer
use.
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. Among the
violations noted during FDA's latest inspection 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, an active ingredient in this product.
The seizures follow warrants issued by the U.S. District Courts
for the District of Puerto Rico and the Eastern District of
Tennessee. The seizures were executed today by the U.S. Marshals
Service at GSK's Cidra, Puerto Rico manufacturing facility, its
Knoxville, Tennessee distribution facility, and a Puerto Rico
distribution facility. GSK has voluntarily recalled some of the
affected lots of Paxil CR and Avandamet; however, it has failed to
recall all affected lots of these products. This failure on the part
of GSK resulted in today's seizures by federal authorities.
IF YOU HAVE BEEN PRESCRIBED PAXIL, YOU MAY WANT TO CONTACT AN
ATTORNEY TO DECIDE WHETHER YOU MAY HAVE RECOURCE.
Related Paxil Information:
Questions
and Answers about the Seizure of Paxil CR
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