Paxil CR recall and seizure hurt patients
In a response to ongoing concerns about manufacturing quality at plants of GlaxoSmithKline, Inc. (GSK), the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Paxil CR. Manufacturing practices for Paxil CR, approved to treat depression and panic disorder, failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity. The FDA action relates to all strengths of Paxil CR (12.5 mg, 25 mg, and 37.5 mg).
"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 this seizure and it does not believe that the drug poses a significant health hazard to consumers. Consequently, FDA urged patients who use Paxil CR 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 Paxil CR is not 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 Paxil CR 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.
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; 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 said that the company is working with the FDA to resolve these issues as quickly as possible. In a similar action and for similar reasons, FDA also seized lots of another drug Avandamet, also manufactured by GlaxoSmithKline.
Recommended article: What should you know about safety of prescription drugs?
"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 this seizure and it does not believe that the drug poses a significant health hazard to consumers. Consequently, FDA urged patients who use Paxil CR 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 Paxil CR is not 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 Paxil CR 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.
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; 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 said that the company is working with the FDA to resolve these issues as quickly as possible. In a similar action and for similar reasons, FDA also seized lots of another drug Avandamet, also manufactured by GlaxoSmithKline.
Recommended article: What should you know about safety of prescription drugs?
posted by eCreativa Media | 2:20 PM
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