The U.S. Food and Drug Administration has just issued yet another massive international recall of valsartan, a prescription medication that is generally used to regulate blood pressure and treat cases of heart failure. For the first several recalls, the FDA said certain brands of valsartan contain N-nitrosodimethylamine (NDMA), a cancer-causing impurity that can be toxic to vital organs such as the liver and may even cause cancer. This newest recall, affecting combination drugs of valsartan that contain amlodipine, points to a similarly dangerous and potentially cancer-causing impurity called N-nitrosodiethylamine (NDEA).
This is yet another expansion of the small, original recall announced in July that only impacted a generic version of the medication that was not available in the United States. The recalls are now world-wide, and this is the sixth recall of the drug since July.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is why we’ve asked these companies to take immediate action to protect patients.”
According to the FDA, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
The expanded recall includes the following manufacturers:
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 Industries Ltd.
[new] Valsartan/Amlodipine – Teva Pharmaceuticals Industries Ltd.
[new] Valsartan/Amlodipine/Hydrochlorothiazide – Teva Pharmaceuticals Industries Ltd.
[new] Valsartan/Amlodipine – Mylan
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“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA commissioner Dr. Scott Gottlieb.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” Dr. Gottlieb continued. “As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
Just in case you’re taking a blood pressure medication that contains the active ingredient valsartan, we’ve also got an FDA-approved list of drugs that are NOT being recalled. If you are taking any of the following medications, you are considered to be safe from the toxic substance that the FDA is warning against:
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
Valsartan/Hydrochlorothiazide (HCTZ) – Northwind Pharmaceuticals
Diovan – Novartis Pharmaceuticals Corp.
Amlodipine and Valsartan – Novel Laboratories, Inc.
Valsartan – Ohm Laboratories, Inc.
Please check the medication bottle label or call the pharmacy that distributed the medication to determine whether you are in possession of one of the recalled drugs. Visit the FDA’s website for instructions on what to do with the medications. You can report any adverse reactions here, on the FDA’s MedWatch page.
If you are taking one of the recalled drugs, contact your doctor as soon as possible, as well as your pharmacist. Because this medication is prescribed to patients with potentially life-threatening conditions, users are not advised to discontinue taking valsartan until an alternative medication is identified and obtained.
The FDA will continue to investigate and update the public as more information becomes available. Please keep an eye on the FDA’s website if you’re at all concerned about the safety of the medications you’re taking.Whizzco