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FDA expands recall of blood pressure drug valsartan due to cancer concern

| CNN – The US Food and Drug Administration expanded the list of drugs being recalled that contain valsartan.

The drug is used as a component in a set of drugs used to treat heart failure and blood pressure.

New to the list are some valsartan products manufactured by Hetero Labs Ltd. in India, which are labeled as Camber Pharmaceuticals Inc. Test results show that some of the products may be tainted.

“China and India supply more than two-thirds of all active drug ingredients used in medicines, industry experts estimate.” – Reuters 

The FDA announced a valsartan recall in July after lab tests revealed that some drugs could have been tainted with a substance linked to higher risk of cancer.

The drug had been recalled in 22 other countries. The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide.

Not all of the drugs containing valsartan were affected.

N-nitrosodimethylamine or NDMA, the impurity the lab tests found, is considered a possible carcinogen by the US Environmental Protection Agency.

It is an organic chemical that has been used to make liquid rocket fuel, and it can be unintentionally introduced through certain chemical reactions.

It’s a byproduct of the manufacturing of some pesticides and fish processing.

Valsartan recall: 4 things patients should know

The medicines that are now a part of this expanded list in the recall are tablets sold by:

  • AvKare
  • A-S Medication Solutions LLC
  • Bryant Ranch Prepack Inc
  • Camber Pharmaceuticals, Inc.
  • H J Harkins Company
  • Northwind Pharmaceuticals
  • NuCare Pharmaceuticals Inc.
  • Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC)
  • Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals)
  • Teva Pharmaceuticals USA (labeled as Actavis).

If you are taking a valsartan drug, look for the company name on your prescription bottle. If the information isn’t on the label, you can call your pharmacy for those details.

The recalled medicine is linked to a manufacturer in China … Read the full story at CNN. 

Expert: Contamination of China-Made Heart Drug Is Just the Tip of the Iceberg

| Paul Huang, Epoch Times – Contamination of a key drug used for treating high blood pressure and heart failure has caused a worldwide recall.

An expert who has been sounding an alarm over the growing reliance by the United States on Chinese-made medicines said this is just another case highlighting the extensive problems of pharmaceuticals made in China.

The U.S. Food and Drug Administration announced on July 13 the recall of 29 types of single and 51 types of combination valsartan medicines.

The recall followed the same move by the European Medicines Agency (EMA) on July 5 when it was informed by China’s Zhejiang Huahai Pharmaceutical—a major global manufacturer of generic valsartan—that the drug had been contaminated by a substance called N-Nitrosodimethylamine (NDMA), which could cause cancer.

Valsartan contamination could have started as early as 2012 according to European regulators, who speculated that it was caused by Zhejiang Huahai changing its manufacturing processes at that time.

This also means that for six years, a large number of patients worldwide likely have been exposed to the cancer-causing element in their valsartan.

Zhejiang Huahai Pharmaceutical did not respond to The Epoch Times’ repeated requests for comment.

The company, which sold $50 million worth of valsartan in 2017 alone, acknowledged in a public statement that some of its valsartan was definitely contaminated, although it did not give out any additional details.

Rosemary Gibson, a senior adviser at The Hastings Center, told The Epoch Times that the case is just the latest scandal showing how defective medicines and pharmaceutical ingredients made by Chinese manufacturers are becoming a health care hazard and even a national security threat for the United States.

“There is a lack of trust in medicines made in China now,” Gibson said … Read more Epoch Times.


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