Order Requires Valsartan Recall Lawsuits To Provide Product Identification for Specific Generic Drug Makers Named
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Suboxone Tooth Decay Lawsuit Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.
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Bard PowerPort Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
AngioDynamics Port Catheter Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Processed Food Lawsuit Lawsuits are being pursued against the food industry over their manufacturing and advertising of ultra-processed foods, which have caused a generation of children to face an increased risk of developing childhood diabetes and other chronic illnesses.
Blood Pressure Drug Recalls Cause Widespread Shortages, As FDA Closes In On Root Cause Of Contamination January 28, 2019 Irvin Jackson Add Your Comments Federal regulators warn that a number of blood pressure drug recalls issued in recent months due to potential cancer-causing impurities in generic valsartan ingredients have led to widespread shortages of the medication, and that similar problems could result in limited supply for other drugs that may be susceptible to the same manufacturing problems. FDA Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, issued a statement on January 25, to update the public about ongoing investigations into impurities in valsartan and other generic versions of angiotensin II receptor blocker (ARB) medications. To mitigate the effects of drug shortages, the agency has set “interim acceptable levels” of nitrosamine impurities, including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which are probable human carcinogens that have been found in valsartan and other similar blood pressure drugs. VALSARTAN LAWSUITS Were you prescribed contaminated Valsartan drugs? Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug. Learn More SEE IF YOU QUALIFY FOR COMPENSATION VALSARTAN LAWSUITS Were you prescribed contaminated Valsartan drugs? Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Since July, the agency has announced numerous recalls for valsartan and other generic drugs, indicating that the impurities likely got into the pills during the manufacturing process, and the agency has been investigating the causes of the contamination. The statement notes, however, that there have been so many recalls due to contamination, that it has led to a valsartan shortage. “We know patients rely on these medicines. Part of our work throughout this process has been to mitigate and prevent shortages, where possible,” Gottlieb and Woodcock say in the statement. “Currently, valsartan products are in shortage, and we know that other types of products may fall into shortage soon.” The statement indicates the potential for shortages has weighed into the FDA’s evaluation of acceptable intake levels for the impurities, leading to what the statement calls “interim acceptable levels.” Those are levels they believe are safe for patients to take for a short period of time until the problem is sorted out. The statement notes that the agency is trying to balance the risk of patients ingesting very low levels of NDMA and NDEA versus not having the medications at all. “While consumers should limit exposure to NDMA and NDEA, these impurities exist in other ingested products, such as some charcoal grilled food items,” the statement notes. “We remind patients taking these medications or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option.” In addition to shortages, the recalls have led to a spike in prices, with the cost of 160 milligram and 80 milligram tablets of generic valsartan more than doubling in September 2018. Valsartan Impurities Investigation Gottlieb and Woodcock also updated the FDA’s investigation into what caused the impurities. The first manufacturer linked to the problem was China-based Zhejiang Huahai Pharmaceutical Co. (ZHP), whose drugs have been placed on import alert, meaning its active ingredients and finished drugs are barred from entering the United States. Since then, NDMA and NDEA have been detected in the drugs of a number of other generic drug manufacturers as well. To date, FDA investigators have determined that the impurities appear to be created when specific chemicals and reaction conditions occur during the manufacturing process, and when manufacturers reuse some materials, such as solvents. However, they warn that the FDA and other investigators are still trying to determine the root causes of the contamination, and NDMA is hard to detect in standard laboratory testing. Gottlieb and Woodcock note that since summer 2018, FDA scientists have developed and refined new testing methods and continue to investigate what processes specifically led to the creation of the impurities. They indicated the FDA will continue to keep the public informed, and encourage anyone who has suffered side effects from recalled valsartan and other hypertension drugs to submit reports to its MedWatch adverse event reporting program. As consumers nationwide continue to face concerns about the safety of pills they have taken in recent years, a number of valsartan lawsuits have been filed by individuals diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other digestive tract cancers after receiving contaminated versions of the blood pressure drug. Tags: Cancer, Drug Recall, Hypertension, NDEA, NDMA, Valsartan More Valsartan Lawsuit Stories Order Requires Valsartan Recall Lawsuits To Provide Product Identification for Specific Generic Drug Makers Named March 27, 2025 Deadlines Leading to First Valsartan Bellwether Trial on Sept. 8, 2025 Outlined by Special Master March 4, 2025 Parties Propose Schedules for Second Wave of Valsartan Bellwether Lawsuits February 20, 2025 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermPhoneThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Hair Relaxer Lawyers To Meet With MDL Judge Amid “Contentious” Disputes Over Bellwether Discovery Plans (Posted: yesterday) Lawyers involved in the federal hair relaxer lawsuits submitted a status report in advance of an MDL status conference tomorrow, highlighting a number of ongoing disputes over Defendant Fact Sheets and a potential Science Day. 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Order Requires Valsartan Recall Lawsuits To Provide Product Identification for Specific Generic Drug Makers Named March 27, 2025
Deadlines Leading to First Valsartan Bellwether Trial on Sept. 8, 2025 Outlined by Special Master March 4, 2025
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