Valsartan Meds Recalled by Teva Pharmaceuticals for Possible Contamination

The United States Food and Drug Administration (FDA) on Tuesday, November 27, 2018 updated its blood pressure drug recall list to warn hypertension patients and consumers of another voluntary valsartan blood pressure medication recall.

Teva Pharmaceuticals issued another voluntary recall for valsartan combination tablets manufactured by Mylan India, including amlodipine-valsartan combination tablets and amlodipine-valsartan-hydrochlorothiazide combination tablets.

The drugs are being recalled due to the possibility that they are contaminated with organic chemical N-nitrosodiethylamine (NDEA), which (of all things) is used to make liquid rocket fuel and is classified as a probable human carcinogen. NEDA is also typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

As of this recall, Teva has now pulled back all of its valsartan drugs on the U.S. market. These ongoing 2018 blood pressure recalls began back on July 13 2018 when three drug companies, including Teva Pharmaceuticals, began recalling medications containing valsartan.

Other blood pressure drugs have been recalled over concerns they also contain trace amounts of NDEA. In early November 2018, another blood pressure drug, irbesartan, was recalled. Next in mid-November 2018 a voluntary recall of losartan potassium hydrochlorothiazide tablets, which are also prescribed to treat hypertension.

The FDA warned that the risk to health may be higher if patients suddenly stop taking any blood pressure medication. As with the other valsartan blood pressure medications recalled, patients taking Amlodipine / Valsartan combination tablets or Amlodipine / Valsartan / Hydrochlorothiazide combination tablets are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment. The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.

Teva Pharmaceuticals USA is notifying its distributors and customers by certified mail and is arranging for return/reimbursement of returned recalled products. Pharmacy distributors and retailers that have product that is being recalled should immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product.

Customers and patients with medical-related questions, information about an Adverse Event or other questions about the Teva products being recalled should contact Teva’s Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email [email protected].

Adverse reactions or other problems experienced with the use of the products may also be reported to Teva directly at 888-838-2872 or to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

A full list of the lots of Teva Pharmaceutical hypertension medications being recalled can be found here on the FDA website.

Valsartan is an angiotensin II receptor antagonist (commonly called an ARB, or angiotensin receptor blocker), that is selective for the type I (AT1) angiotensin receptor. Valsartan is the generic drug name associated with the trade name Diovan by Novartis.

Comparison to ACE Inhibitor Drugs
Valsartan blocks the actions of angiotensin II, which include constricting blood vessels and activating aldosterone, to reduce blood pressure.

Valsartan binds to angiotensin type I receptors (AT1), working as an antagonist. Valsartan’s mechanism of action is different compared to ACE inhibitor drugs, which block the conversion of angiotensin I to angiotensin II. Since valsartan acts at the receptor, it can provide more complete angiotensin II antagonism because angiotensin II is also generated by other enzymes in addition to ACE (angiotensin-converting-enzyme). Also compared to ACE inhibitors (such as lisonpril), valsartan does not inhibit the metabolism of bradykinin, which is an inflammatory mediator that causes vasodilation, reducing blood pressure. Bradykinin dilates blood vessels via the release of prostacyclin, nitric oxide, and Endothelium-Derived Hyperpolarizing Factor. Bradykinin-degrading activity in cells could be inhibited in a concentration-dependent manner by the ACE inhibitors lisinopril, ramiprilat, and captopril, which supports increased vasodilation effects of bradykinin during ACE inhibition treatment.

ACE, is a central component of the renin–angiotensin system (RAS), which controls blood pressure by regulating the volume of fluids in the body. ACE or Angiotensin-Converting-Enzyme converts the hormone angiotensin I to the active vasoconstrictor angiotensin II.

ACE indirectly increases blood pressure by causing blood vessels to constrict. ACE inhibitors are widely used as pharmaceutical drugs for treatment of cardiovascular diseases.

Teva Pharmaceutical Industries Ltd (TEVA) is an Israeli multinational pharmaceutical company headquartered in Petah Tikva, Israel, known primarily for generic drugs. Teva is also involved in active pharmaceutical ingredients and proprietary pharmaceuticals. Teva is the largest generic drug manufacturer in the world, and one of the 15 largest pharmaceutical companies worldwide.

SOURCE: Gräfe M1, Bossaller C, Graf K, Auch-Schwelk W, Baumgarten CR, Hildebrandt A, Fleck E. Effect of angiotensin-converting-enzyme inhibition on bradykinin metabolism by vascular endothelial cells. Am J Physiol. 1993 May;264(5 Pt 2):H1493-7.

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