* The acceptable intake is a daily exposure to a compound such as NDMA or NDEA that results in a 1:100,000 cancer For comparison with the levels of NDMA found in some common foods, please see our Aug. 20, 2018, The agency also updated the list of valsartan products under recall and the list of valsartan products not under recall.Teva is recalling all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to the presence of N-Nitrosodiethylamine (NDEA). (PDF/46.54 KB) (PDF/50.51 KB) (PDF/97.56 KB)
Through each step of our investigation, we’ve uncovered new information and taken a number of actions, including regulatory and advisory actions, where appropriate, to prevent the presence of unacceptable levels of these impurities. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Patients may have returned medication unnecessarily if their supply was not part of a recall, but they were unsure. Health care professionals and patients should check this statement frequently for any updates.FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. (PDF/142.79 KB) (PDF/699.84 KB) The agency reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. For the full list of all side effects reported with Exforge HCT, see the Exforge HCT must not be used in people who are hypersensitive (allergic) to the Exforge HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.For more information about treatment with Exforge HCT, read the Please note that the size of the above document can exceed 50 pages.You are therefore advised to be selective about which sections or pages you wish to print.Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.This medicine is authorised for use in the European Union. Our website services, content, and products are for informational purposes only. FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities.
It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Exforge HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide). (PDF/706.75 KB) It also is important to know not all ARBs contain NDEA or NDMA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.ScieGen’s recall affects about 1 percent of the irbesartan drug products in the U.S. market.Additionally, Aurobindo, which manufactures the active pharmaceutical ingredient (API) for ScieGen’s irbesartan products, is recalling all unexpired lots of its irbesartan API supplied to the U.S. market with NDEA. (PDF/94.4 KB)