FDA recalls heart meds used to treat high blood pressure over cancer concerns

[Swordsmyth]

The U.S. Food and Drug Administration has issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.
“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement Saturday. “However, not all products containing valsartan are being recalled.”
Officials say NDMA is classified as a probable human carcinogen —a substance that could cause cancer. They said those findings are based on results from recent laboratory tests.
The administration said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”


To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
Below are the specific medicines being recalled:

Medicine	Company
Valsartan	Major Pharmaceuticals
Valsartan	Solco Healthcare
Valsartan	Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)	Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)	Teva Pharmaceuticals Industries Ltd.

More at: https://www.charlotteobserver.com/ne...214917390.html

[Swordsmyth]

In an ongoing investigation, the Food & Drug Administration has expanded the swath of the recall of the drug valsartan, which is used to treat high blood pressure and heart failure. The recalled drugs, manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, contain the chemical N-nitrosodimethylamine, or NDMA, which has been found to cause cancer in humans based on laboratory studies, the agency says.

Last month, the FDA issued a voluntary recall for some valsartan tablets and has since expanded it twice to include additional products from more drug companies, as well as some tablets with valsartan and hydrochlorothisazide (HCTZ).
The recall has spread globally with Health Canada and the European Medicines Agency having also recalled drugs using valsartan provided by Zhejiang Huahai.
The valsartan tablets (dosages 40mg to 320mg) the FDA has recalled include products from the following drug companies:

• A-S Medication Solutions (labeled as Solco Healthcare)
• Bryant Ranch Prepack
• HJ Harkins Company
• Northwind Pharmaceuticals
• Prinston Pharmaceutical Inc. (labeled as Solco Healthcare)
• Teva Pharmaceuticals Industries Ltd. (some labeled as Actavis, some as Major Pharmaceuticals)

Recalled valsartan/hydrochlorothiazide tablets (dosages range from 80mg/12.5mg to 320mg/25 mg) include products from these drug companies:

• AvKARE
• A-S Medication Solutions
• Northwind Pharmaceuticals
• Prinston Pharmaceutical (labeled as Solco Healthcare)
• Proficient Rx
• Remedy Repack
• Teva Pharmaceuticals (some labeled as ACtavis)

Not all valsartan products contained NDMA, the agency says; the FDA has a list of drugs with NDMA and those not affected on its website.
Consumers taking any medication with valsartan can compare their prescription bottle to the FDA's list to determine if their drugs have been recalled. Patients can also contact their pharmacist, who may be able to provide valsartan from a drug maker not involved in the recall, the FDA says.
Patients taking these medications should continue taking them until their doctor or pharmacist has a replacement drug or treatment, the FDA says.
The Environmental Protection Agency considers NDMA a carcinogen that can cause liver damage in humans. The FDA's scientists estimate that one additional case of cancer would develop over the lifetime of 8,000 patients had they all taken the highest valsartan dose (320 mg) from the recalled batches daily for four years – the length of time some levels of the chemical impurity may have been added.

More at: https://www.usatoday.com/story/money...ity/921566002/

[timosman]

How expensive it is to manufacture these drugs that the production needs to be off-shored?

[phill4paul]

Another Chinese pharmaceutical recall. Tell me again why globalized free trade with a country that doesn't adhere to our standards is so wonderful? First they killed the dogs, now they are killing the elderly. This is the second medication my mom is on that has been recalled in a month, the first being Valsartan.

Thyroid medication recalled: Chinese manufacturer's failed inspection leads to recall.

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

https://www.fda.gov/Safety/Recalls/ucm616601.htm

[timosman]

Everything was fine until Trump showed up.

[donnay]

Yay! Big cHARMa! No safety test, No transparency-- sounds a lot like Big pHARMa.

[Zippyjuan]

The U.S. Food and Drug Administration has issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.
“This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, the FDA said in a statement Saturday. “However, not all products containing valsartan are being recalled.”
Officials say NDMA is classified as a probable human carcinogen —a substance that could cause cancer. They said those findings are based on results from recent laboratory tests.
The administration said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”


To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
Below are the specific medicines being recalled:

Medicine	Company
Valsartan	Major Pharmaceuticals
Valsartan	Solco Healthcare
Valsartan	Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ)	Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ)	Teva Pharmaceuticals Industries Ltd.

More at: https://www.charlotteobserver.com/ne...214917390.html

https://www.precisionvaccinations.co...umans-says-epa

It is estimated that over the course of a person’s lifetime, consuming 96 nanograms of NDMA would result in less than one additional case of cancer for every 100,000 people.

Which means this risk to humans is minimal.

To put this in context, currently, 1 out of every 3 people in the USA will experience cancer during their lifetime.

[Swordsmyth]

https://www.precisionvaccinations.co...umans-says-epa

They don't tell you how many people were merely sickened and made more vulnerable to other ailments.

[phill4paul]

https://www.precisionvaccinations.co...umans-says-epa

Did they put on the disclaimer that there is a minimal risk of cancer from manufacturing impurities?

[timosman]

Did they put on the disclaimer that there is a minimal risk of cancer from manufacturing impurities?

He just explained to you it isn't necessary. An acceptable risk you don't need to know about.

[Swordsmyth]

European and North American regulators have found a second toxin that may cause cancer in humans in a commonly used blood pressure drug made by Chinese firm Zhejiang Huahai Pharmaceutical Co Ltd.

Health regulators in the European Union, United States and Canada had already recalled drugs made with the company’s active pharmaceutical ingredient valsartan after finding traces of the chemical N-nitrosodimethylamine (NDMA), considered a potential human carcinogen, in the medicine.

On Thursday, the European Medicines Agency (EMA) said a different chemical, N-nitrosodiethylamine (NDEA), had been detected in products produced before 2012. The U.S. Food and Drug Administration (FDA) also said it had detected the chemical in the recalled drug.

More at: https://uk.reuters.com/article/us-ph...-idUKKCN1LT2A7

[Zippyjuan]

European and North American regulators have found a second toxin that may cause cancer in humans in a commonly used blood pressure drug made by Chinese firm Zhejiang Huahai Pharmaceutical Co Ltd.

Health regulators in the European Union, United States and Canada had already recalled drugs made with the company’s active pharmaceutical ingredient valsartan after finding traces of the chemical N-nitrosodimethylamine (NDMA), considered a potential human carcinogen, in the medicine.

On Thursday, the European Medicines Agency (EMA) said a different chemical, N-nitrosodiethylamine (NDEA), had been detected in products produced before 2012. The U.S. Food and Drug Administration (FDA) also said it had detected the chemical in the recalled drug.

More at: https://uk.reuters.com/article/us-ph...-idUKKCN1LT2A7

Detected at what level? Anything potentially harmful? How much is bad? What is the actual risk? They can detect things at one part per trillion these days.

“Data on levels of NDEA are currently very limited, and EMA will provide further information on whether its presence impacts the risk assessment once more information becomes available.”