Another blood pressure drug, irbesartan, recalled over cancer-causing impurity

[Swordsmyth]

A drug company on Friday announced the recall of eight more lots of irbesartan blood pressure medication after testing revealed the drugs contained trace amounts of a carcinogen.
Prinston Pharmaceuticals recalled one lot of irbesartan tablets and seven lots of irbesartan HCTZ tablets. The medication contained unacceptable levels of the probable carcinogen nitrosodiethylamine, or NDEA, the company said.
The drugs ingredients were made by Zhejiang Huahai Pharmaceuticals, a factory in China that has been linked to several recalls of commonly prescribed blood pressure drugs since July. The Food and Drug Administration has issued a warning letter and halted all new drug shipments from Zhejiang Huahai since uncovering a series of problems at the factory.
Another factory in India, Hetero Labs Limited, also has been tied to multiple recalls.
The irbesartan recall is the latest involving a large class of blood pressure drugs called angiotensin II receptor blockers, which work by blocking the effects of a hormone that narrows blood vessels. Several versions of valsartan and losartan also have been recalled since July.
Many of these commonly prescribed drugs are not part of the recall. Consumers can check the FDA's website for a full list of recalled drugs or ask their pharmacist.


Prinston advised patients to check with their doctor or pharmacist before they stop taking their medications. Discontinuing a recalled drug could cause more immediate harm than staying on the medication.
Prinston said the following irbesartan and irbesartan hydrochlorothiazide tablets have been recalled:
• Irbesartan, 300 mg, 90 count, lot number 331B18009, expires February 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, 30 count, lot number 327A18001, expires March 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, lot number 327A18002, expires March 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, 90 count, lot number 327B18008, expires March 2021
• Irbesartan HCTZ, 300 mg/12.5 mg, 90 count, lot number 327B18009, expires March 2021
• Irbesartan HCTZ, 150 mg/12.5mg 30 count, lot number 325D18004, expires March 2021
• Irbesartan HCTZ, 150 mg/12.5 mg, 90 count, lot number 325B18004, expires March 2021
• Irbesartan HCTZ, 150 mg /12.5 mg, 30 count, lot number 325D18005 expires March 2021


https://news.yahoo.com/fda-another-b...225207558.html

[Zippyjuan]

Should all products containing trace amounts of nitrosodiethylamine, or NDEA be recalled? Including all cigarettes and cured meats?

Humans may be exposed to low levels of N-nitrosodimethylamine through the ingestion of food that contains it, such as cured meat products and smoked fish. Other exposures to the chemical may be from drinking contaminated water and from breathing cigarette smoke and contaminated ambient air

How much is potentially harmful?

Acute exposure to N-nitrosodimethylamine may cause liver damage in humans, with symptoms that
include nausea, vomiting, headaches, and malaise.

Cancer Risk:

Data from human studies are of limited use because human exposure to nitrosamines generally results from contact with mixtures of these compounds.

EPA estimates that, if an individual were to continuously breathe air containing N-nitrosodimethylamine at an average of 0.00007 micrograms per cubic meter (µg/m ) (7 x 10 milligrams per cubic meter, mg/m ) over his or her entire lifetime, that person would theoretically have no more than a one-in-a-million increased chance of developing cancer as a direct result of breathing air containing this chemical.

https://www.epa.gov/sites/production...ethylamine.pdf



Or should companies be able to put whatever they want into products? Get rid of regulations which only add costs to products? Let the free market decide?

[Swordsmyth]

Should all products containing trace amounts of nitrosodiethylamine, or NDEA be recalled? Including all cigarettes and cured meats?



How much is potentially harmful?







https://www.epa.gov/sites/production...ethylamine.pdf



Or should companies be able to put whatever they want into products? Get rid of regulations which only add costs to products? Let the free market decide?

Science, the courts and consumer advocates could handle those questions without the regulatory state and pharmaceutical companies in 3rd world countries can't be trusted.

The regulatory state creates the illusion of safety and the pharmaceutical companies take advantage of that.

[Swordsmyth]

A recall of common blood pressure medication losartan has been expanded for a fifth time after manufacturer Torrent Pharmaceuticals found a possibly carcinogenic impurity in more batches of the drug, federal health officials said.
Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were under recall, the U.S. Food and Drug Administration said Thursday.
The lots contained levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels determined by the FDA. NMBA is a "potential human carcinogen," the FDA says.


"The risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment," federal health officials wrote in a statement.
The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. The manufacturing change may generate the contaminants "when specific chemicals and reaction conditions are present" and can result of reusing materials such as solvents.

More at: https://news.yahoo.com/more-blood-pr...155742313.html

[Anti Federalist]

The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India

Why has the manufacturing of critical medical supplies been outsourced to China and India?

[donnay]

President Trump, Communist China, and Pharma Outsourcing
https://www.outsourcedpharma.com/doc...tsourcing-0001