FDA: Recalled blood pressure medicine has cancer-causing chemical

(WDHN) – A common drug used to treat blood pressure problems is now under a massive, international recall after being said to contain a cancer-causing chemical.

The U.S. Food and Drug Administration said valsartan contains a chemical that can cause cancer called N-nitrosodimethylamine (NDMA).

“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 in a news release.

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 Dr. 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. The list was compiled by the FDA:

• 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, which can be found here.

The agency also advised patients to contact their healthcare providers — both the doctor and pharmacist who prescribed and dispensed the medication.