Part of our work throughout this process has been to mitigate and prevent shortages, where possible,” Gottlieb and Woodcock say in the statement.
The US Food and Drug Administration is warning of a shortage of a class of drugs used by millions to treat high blood pressure. FDA Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, issued a 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.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.
Reason for shortage: Requirements related to complying with good manufacturing practices. 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. Drug Shortage Report for TEVA-TELMISARTAN. Updated August 14, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. TELMISARTAN: Strength(s) 40MG: Dosage form(s) TABLET: Route of administration: ORAL: Packaging size: 100: ATC code: C09CA: ATC description: ANGIOTENSIN II ANTAGONISTS, PLAIN: Reason for shortage: Disruption of the manufacture of the drug. This field is for validation purposes and should be left unchanged.This field is for validation purposes and should be left unchanged. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. “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 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.
Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. It is a searchable database that provides up-to-date information for consumers and healthcare professionals related to current drug shortages. “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.
Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment.
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