DENVER — A common drug used to treat blood pressure problems is now under a massive, international recall, according to FOX7 Austin.
The U.S. Food and Drug Administration said valsartan contains a chemical that can cause cancer called N-nitrosodimethylamine.
“The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA said.
While a valsartan recall was announced a few weeks ago, it did not include the U.S. and affected only the generic version.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The list of valsartan drugs being recalled now includes pills made around the world.
- Valsartan – Prinston – Pharmaceutical Inc.
- Valsartan – AvKARE
- Valsartan – A-S Medication Solutions LLC
- Valsartan – Bryant Ranch Prepack, Inc.
- Valsartan – HJ Harkins Company
- Valsartan – Major Pharmaceuticals
- Valsartan – Solco Healthcare
- Valsartan – Northwind Pharmaceuticals
- Valsartan – Teva Pharmaceuticals Industries Ltd.
- Valsartan/Hydrochlorothiazide (HCTZ) – Proficient Rx LP
- Valsartan/Hydrochlorothiazide (HCTZ) – Remedy Repack
- Valsartan/Hydrochlorothiazide (HCTZ) – Solco Healthcare
- Valsartan/Hydrochlorothiazide (HCTZ) – Teva Pharmaceuticals Injustries Ltd.
The FDA has also compiled an updated list of medications not included in the recall:
- Amlodipine and Valsartan – Alembic Pharmaceuticals Limited
- Valsartan/Hydrochlorothiazide (HCTZ) – Alembic Pharmaceuticals Limited
- Valsartan – Alembic Pharmaceuticals Limited
- Byvalson (Nebivolol and Valsartan – Allergan, Inc.
- Valsartan – American Health Packaging
- Valsartan – Amneal Pharmaceuticals LLC
- Diovan and Valsartan – Aphena Pharma Solutions
- Valsartan/Hydrochlorothiazide (HCTZ) – Apotex Corp.
- Amlodipine and Valsartan – Aurodindo Pharma Limited
- Valsartan – AcPAK
- Valsartan – Cardinal Health
- Diovan – Carilion Materials Management
- Amlodipine and Valsartan – Gavis Pharmaceuticals, LLC
- Valsartan – Jubilant Cadista Pharmaceuticals Inc.
- Valsartan – Lucid Pharma
- Amlodipine and Valsartan – Lupin
- Valsartan – Macleods Pharmaceuticals USA
- Amlodipine and Valsartan – Mylan
- Valsartan/Hydrochlorothiazide (HCTZ) – Northwind Pharmaceuticals
- Diovan – Novartis Pharmaceuticals Corp.
- Amlodipine and Valsartan – Novel Laboratories, Inc.
- Valsartan – Ohm Laboratories, Inc.
The FDA said if a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the specific company.
The agency also advised patients to contact their health care providers — both the doctor and pharmacist who prescribed and dispensed the medication.AlertMe