All over the world, the core cancer medicine is massively withdrawn due to the threat of cancer
The Food and Drug Administration (FDA) has added to the revocation list dozens of batches of drugs prescribed for the treatment of high blood pressure. The reason was the fear that they might be contaminated with a carcinogenic chemical. This time the review is distributed worldwide.
"Valsartan" (Valsartan)A prescription drug is usually prescribed to treat blood pressure and heart failure, and is currently being used extensively throughout the world.
The FDA claims that the drug contains a cancer-causing chemical called N-nitrosodimethylamine (NDMA). This chemical is toxic to the liver and other organs.
“The presence of NDMA was unexpected and is believed to be related to changes in the way the active substance is manufactured,” the FDA said.
Ранее contaminated drugs were found in factories in China that produce Valsartan ingredients and send them to generic companies around the world.
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“We have carefully evaluated the valsartan-containing products marketed in the United States and have found that the Valsartan marketed by these specific companies does not meet our safety standards. That’s why we asked these companies to take immediate action to protect patients,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Now the review has become global due to the fact that the FDA added to the list of new manufacturers:
- Valsartan - Princeton - Pharmaceutical Inc.
- Valsartan - AvKARE
- Valsartan – AS 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 also compiled an updated list of drugs 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 - Lupine
- 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 offers to return the drugs from the list to the pharmacy or the doctor who issued them.
How serious is the risk of cancer
The FDA, which tests all drugs from foreign plants for use in the US, says the risk is very low. However, the FDA also notes that the levels of NDEA or NDMA, cancer-causing agents contained in samples are unacceptably high.
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Because stopping heart medication is more at risk than infected drugs in the short term, doctors advise patients to continue taking blood pressure drugs until a replacement is prescribed, even if this drug is included in a review.
As the FDA is investigating the manufacturing process that led to pollution, Gibson expects more feedback in the near future.
“This is just the tip of the iceberg,” she said.
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