I ran into the shortage issue in October 2019. Canadians with questions about the recalls can contact: Torrent recalled several lots of losartan tablet presentations due to an impurity found in the active pharmaceutical ingredient. OTTAWA – Health Canada is advising Canadians that multiple lots of Losartan-containing drugs are being voluntarily recalled by Teva Canada, Apotex Inc., Pharmascience Inc., and Pro Doc Limitée because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). A non-compliant rating does not necessarily indicate a product safety concern. Any application of this information for any purpose shall be limited to personal, non-commercial use.

USA TODAY. Losartan is an angiotensin receptor blocker (ARB) drug, also known as a “sartan.” Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. In December 2018, Health Canada requested all companies that market sartans in Canada to test products already on the market and those to be released in Canada for N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). B.P. Health Canada routinely inspects facilities or assesses inspection results from trusted international regulatory partners to make sure they meet these standards and maintains a

Drug shortages can occur for a variety of reasons.The factors currently affecting drug supply are shortages of raw materials, quality control issues which lead to voluntary withdrawal and longer production times for some products and competition among drug manufacturers. 0 comment. Amid blood pressure medicine shortage, take tainted losartan, says FDA. Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA) 200 mg SDV (NDC 63323-710-50) Available Check Wholesaler Inventory Demand increase for the drug: 500 mg SDV (NDC 63323-711-00) Backordered. Teva Canada is voluntarily recalling two lots of combination Losartan/hydrochlorothiazide (HCTZ) tablets after testing of one lot identified levels of NMBA above what is considered reasonably safe if the drug were taken over a lifetime. Lupin, Sandoz, and Zydus did not provide a reason for the shortage. A 47-year-old female asked: Is it safe to quit bystolic (nebivolol) 5 mg on it for a year new dr doesn't want me to take it Thanks ? Health Canada continues to hold companies responsible for the safety and effectiveness of drugs sold in Canada and expects manufacturers to take any necessary actions to prevent the generation of nitrosamine impurities. Patients with questions or concerns about any drug they are taking, including on what to do if that drug is not readily available, should speak to their healthcare professional. NMBA is potentially a human carcinogen, which means that long-term exposure could increase the potential risk of cancer. As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients taking these medications, since the potential risk of cancer is with long-term exposure to the impurities. The problem is expected to ease somewhat with renewed production in some cases and takeover of supply by … There are alternative products currently available on the Canadian market. Canadians with questions about the recalls can contact: Apotex Inc., Pharmascience Inc., and Pro Doc Limitée are voluntarily recalling multiple lots of Losartan-containing products as a precaution.  Losartan is an angiotensin receptor blocker (ARB) drug, also known as a “sartan.” Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. medications: Bystolic (nebivolol) typically doesn't cause a change in potassium level. Being the kind of patient who does as he/she is told and think little of the pills. Health Canada has tested more than 50 samples of sartan drugs and will continue to post results of any new samples it tests on its  A non-compliant rating means that Canadian companies can no longer import drugs that contain APIs from this site unless they are medically necessary.  The Department will take further steps as required to confirm that appropriate and timely action is taken to protect the health and safety of Canadians. Patients should not stop taking their medication unless advised to do so by their healthcare provider. 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. Health Canada encourages consumers to report any health product-related side effects or complaints to the Department. An API is the active ingredient in a drug that produces an effect on the body. Rising discontinued losartan in August 2019. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. Monthly Archives: January 2020 Story 59 – Losartan again. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Teva discontinued losartan in 2018. It means that the Department has identified issues with how the company is following good manufacturing processes and procedures. Created June 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. A reader from northern Ontario writes: I am also caught in the shortage of Losartan 100 mg and with previous writers, I fear for the future. If t ... Read More. Health Canada encourages Canadians to visit drugshortagescanada.ca for information on drug shortages and discontinuances. These recalls represent all lots of drugs distributed in Canada that contain Losartan API manufactured at Hetero Labs Ltd. Unit 1. 0. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. APIs are used in the manufacture of finished “dosage form” drugs (such as pills, capsules or tablets).  Health Canada continues to monitor the supply situation. Next release September 2020.