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March 6, 2005

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FDA seizes depression, diabetes drugs at GlaxoSmithKline
Houston Chronicle Mar 5 2005 1:29PM GMT
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FDA News

March 4, 2005
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

U.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.

Questions and Answers about the Seizure of Paxil CR and Avandamet
March 4, 2005

1. What are these drugs and what are they used to treat?

Avandamet is a combination product containing 2 drugs (rosiglitazone maleate and metformin hydrochloride) for the treatment of type 2 diabetes mellitus.

Paxil CR is a controlled release medication for the treatment of major depressive disorder and panic disorder.

2. What action did FDA take?

FDA and the Department of Justice have filed three actions in federal court to seize remaining stocks of these products (Avandamet and Paxil CR) in three locations. The seizures are meant to prevent further distribution of the products.

3. Why did FDA take this action?

FDA took this action because several inspections of the GSK manufacturing facility where these products are made since 2002 revealed significant violations of FDA's current Good Manufacturing Practice (GMP) regulations at this facility. These violations have not been adequately corrected by the firm and could result in production of poor quality drug products that potentially could pose risks to consumers.

FDA inspections of the facility that manufactures Avandamet and Paxil CR revealed deficiencies in the process controls in place to help assure manufacturing conditions and practices result in a high quality product.

4. What were the manufacturing problems that resulted in FDA's seizure action?

FDA inspections revealed that some lots of Avandamet tablets are not always manufactured uniformly and that these tablets may not have an accurate dose of rosiglitazone (one of the two active ingredients in Avandamet). FDA also found that some lots of Paxil CR tablets are not manufactured properly and can split apart, so that patients may receive a portion of the tablets that lack any active ingredient or a portion that contains the active ingredient and does not have the intended controlled-release effect.

5. What impact will FDA's seizure of these drugs have on their supply?

The seizure of Avandamet and Paxil CR could result in a lack of availability of both drugs until the company is able to correct the manufacturing problems that necessitated the seizure.

FDA has determined that there are other products to treat the diseases for which these two products are used.

Approved versions of the individual components of Avandamet (i.e., rosiglitazone and metformin) are available in the same doses as those found in the combination Avandamet tablets subject to seizure, with the exception of the 1 mg dose of rosiglitazone.

Approved versions of the immediate release form of Paxil are also available.

6. When will these drugs be available again?

FDA will attempt to ensure that the manufacturer corrects the manufacturing deficiencies as soon as possible so that production of new product that meets our public health high quality standards can occur.

7. What does the seizure of these drugs mean for patients? What should patients do?

Patients taking either of these drugs should continue taking their Avandamet and/or Paxil CR tablets and should talk to their health care provider about alternative forms of rosiglitazone (Avandia), metformin and/or Paxil or alternative products that could be taken until the manufacturing problems with these drugs have been corrected.

8. Does either of these products pose a risk to consumers taking them?

FDA does not believe that the products subject to this seizure pose a significant health hazard to consumers.

FDA is concerned that the extent of the manufacturing problems noted at the Cidra GSK facility could adversely affect the quality of these drug products, resulting in potential risk to consumers.

9. What doses of each drug are affected?

The following doses of Avandamet and Paxil CR tablets are subject to the seizure:

Avandamet 1 mg/500mg
Avandamet 2 mg/500 mg
Avandamet 2 mg/1,000 mg
Avandamet 4 mg/500 mg
Avandamet 4 mg/1,000 mg
Paxil CR 12.5 mg, 25 mg and 37.5 mg tablets

10. Is the immediate release form of Paxil subject to the seizure?

No, 10 mg, 20 mg, 30 mg, 40 mg of the immediate release form of Paxil are approved and not subject to these seizures. Patients can take these with confidence.

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