Avandamet patients hurt by recall and seizures
In a response to ongoing concerns about manufacturing quality, the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Avandamet tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for Type II Diabetes drug 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."
While it is too early to say if the FDA is getting its act together but FDA has not done a terrific job when it comes to drugs like Vioxx, Celebrex, Bextra, Crestor, Tysabri, Adderall, and Prozac.
FDA says that 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 urged patients who use Avandamet 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 Avandamet is not medically necessary and that alternative products are available for consumer use. 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.
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. 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.
GlaxoSmithKline says that in the short term, it is expected that the FDA action will result in a shortage of patient supplies for Avandamet. It added that the company is working with the FDA to resolve these issues as quickly as possible.
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"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."
While it is too early to say if the FDA is getting its act together but FDA has not done a terrific job when it comes to drugs like Vioxx, Celebrex, Bextra, Crestor, Tysabri, Adderall, and Prozac.
FDA says that 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 urged patients who use Avandamet 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 Avandamet is not medically necessary and that alternative products are available for consumer use. 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.
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. 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.
GlaxoSmithKline says that in the short term, it is expected that the FDA action will result in a shortage of patient supplies for Avandamet. It added that the company is working with the FDA to resolve these issues as quickly as possible.
Recommended article: What should you know about prescription drugs?
posted by eCreativa Media | 2:04 PM
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