# Lifestyles & Discussion > Personal Health & Well-Being >  Another Heart Medicine Was Just Recalled For Containing A Likely Carcinogen

## Swordsmyth

If  you take a medicine called Irbesartan, used to treat high blood  pressure and hypertension, you'll want to check the label. The FDA  announced a voluntary recall of the drug due to trace amounts of the NDEA (N-nitrosodiethylamine) on behalf of Sciegen Pharmaceuticals.
The  substance occurs naturally in certain foods, drinking water, air  pollution, and industrial processes, and it has been classified as a  probable human carcinogen by the International Agency for Research on  Cancer.
Twenty-two  batches of the drug, with distribution dates between January 2016 and  December 2017, were recalled. The bottles affected are labeled  "Westminster Pharmaceuticals" or "GSMS Incorporated," and are 30- or  90-count bottles of 75mg, 150mg, or 300mg tablets. The FDA has full details of the bottles affected, including the lot number, on its website.
If you do have one of the affected bottles, contact your doctor before you stop taking the medicine, the announcement says.  "The risk of harm to a patients health may be higher if the treatment  is stopped immediately without any alternative treatment."

More at: https://www.yahoo.com/lifestyle/hear...185400209.html

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## Zippyjuan

> The substance occurs naturally in certain foods, drinking water,


Better ban those too, eh?

"Traces found".  How much and how much is associated with a cancer risk?

Study tried to find out:  https://www.bmj.com/content/362/bmj.k3851




> The results do not imply a markedly increased short term overall risk of cancer in users of valsartan contaminated with NDMA.

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## Swordsmyth

> Better ban those too, eh?
> 
> "Traces found".  How much and how much is associated with a cancer risk?
> 
> Study tried to find out:  https://www.bmj.com/content/362/bmj.k3851


Let's put trace amounts in everything we consume then.

As long as each source only contained trace amounts it couldn't possibly add up to a dangerous amount, right?

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## Zippyjuan

> Let's put trace amounts in everything we consume then.
> 
> As long as each source only contained trace amounts it couldn't possibly add up to a dangerous amount, right?


"Trace amounts" can now be measured in parts per trillion. At that level you can find almost anything in everything. One part per billion is the same as one pinch of salt on ten tons of potato chips. One part per trillion is a pinch of salt in 1,000 tons of potato chips.

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## Swordsmyth

*Blood pressure medicine recall expands amid cancer concerns*

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## donnay

> *FDA Recalls Yet Another Blood Pressure Medication, Losartan, Due to Cancer Concerns*
> 
> By BRITTANY SHOOT November 13, 2018
> The United States Food and Drug Administration (FDA) is recalling losartan, a blood pressure medication, after finding contamination that could cause cancer.
> 
> The voluntary recall of losartan potassium hydrochlorothiazide by pharmaceutical company Sandoz Inc., is for 100 milligram/25 milligram tablets with the lot number JB8912. The affected product was distributed nationwide on or after October 8, 2018. In total, the recall encompasses less than 1% of the national losartan drug products. The FDA reports that so far, Sandoz has not received any reports of adverse events related to the drug.
> 
> The losartan lot being recalled was found to be contaminated with trace amounts of an impurity, N-nitrosodiethylamine (NDEA). NDEA is an organic chemical that is classified as a probable human carcinogen and is used to make liquid rocket fuel. It’s also a byproduct of pesticide manufacture and of fish processing.
> 
> ...


http://fortune.com/2018/11/12/fda-dr...zen.yandex.com

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## donnay

> *Two more blood pressure drugs recalled for potential cancer risk*
> Brett Molina, USA TODAY
> 
> Teva Pharmaceuticals has launched a voluntary recall into two drugs used to treat high blood pressure as yet more medications face concerns over a possible cancer risk.
> 
> In a statement from Teva posted by the Food and Drug Administration, the recall affects all lots of combination tablets featuring the drugs amlodipine and valsartan and another combo drug featuring amlodipine, valsartan, and hydrochlorothiazide.
> 
> The drugs could contain an impurity called N-nitroso-diethylamine (NDEA), which has been classified as a possible human carcinogen, the FDA said.
> 
> ...


https://www.usatoday.com/story/news/...zen.yandex.com

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## Zippyjuan

So should government regulate what is allowed in medicines? Keep potentially harmful things out?  Or should a company be free to add whatever they want to them- free market- and let people die/ decide?

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## donnay

> So should government regulate what is allowed in medicines? Keep potentially harmful things out?  Or should a company be free to add whatever they want to them- free market- and let people die/ decide?


Free market and Judicial Systems would work just fine.  All of government's alphabet agencies give people a false sense of security.

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## Zippyjuan

> Free market and Judicial Systems would work just fine.  All of government's alphabet agencies give people a false sense of security.


So it OK for them to put whatever they want in.

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## donnay

> So it OK for them to put whatever they want in.


If they want to stay in business and not be sued or imprisoned for negligence, then yes.

I believe people would pay more attention then and not solely rely on the alphabet agencies that pretend they are there for their safety.

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## Zippyjuan

> If they want to stay in business and not be sued or imprisoned for negligence, then yes.
> 
> I believe people would pay more attention then and not solely rely on the alphabet agencies that pretend they are there for their safety.


The burden of proof of any risk or harm is on the consumers then.  They have to provide the testing and diagnostics to prove that that particular pill directly caused their problems. Then you need your own money to challenge the deep pockets of the company producing it.

If something causes cancer, how do you know it was the cause of your specific cancer?  Cancer takes time to develop.  You did, ate and drank thousands of different things.  Which of them caused your cancer? Who do you sue?  Or maybe it was just genetics- you inherited bad genes and your parents were at fault.

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## donnay

> The burden of proof of any risk or harm is on the consumers then.  They have to provide the testing and diagnostics to prove that that particular pill directly caused their problems. Then you need your own money to challenge the deep pockets of the company producing it.
> 
> If something causes cancer, how do you know it was the cause of your specific cancer?  Cancer takes time to develop.  You did, ate and drank thousands of different things.  Which of them caused your cancer? Who do you sue?  Or maybe it was just genetics- you inherited bad genes and your parents were at fault.


And you think the FDA and CDC do any of the testing?  Hahahahahahahahahaha!

With liberty there are always risks.

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## Zippyjuan

> And you think the FDA and CDC do any of the testing?  Hahahahahahahahahaha!
> 
> With liberty there are always risks.


With everything there are risks.

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## donnay

> With everything there are risks.


Correct, especially if you blindly trust the FDA and CDC.

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## Ender

> With everything there are risks.


No business would purposely put bad elements in a product in a free trade environment that is not controlled/subsidized by .gov.

If something bad happened to a customer- BAM- no more customers and no more money.

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## Swordsmyth

Mylan  NV said on Tuesday it is expanding a nationwide voluntary recall of its  blood pressure medicine valsartan to include all lots, two weeks after  it recalled select batches.The  drugmaker said it was recalling 104 additional lots "out of an  abundance of caution" after the valsartan-containing products were found  to contain traces of a probable cancer-causing impurity.
Several  drugmakers, including Teva Pharmaceutical Industries Ltd, have recalled  batches of valsartan and drugs containing the substance that are  suspected to be tainted with probable carcinogens N-nitrosodiethylamine  (NDEA)and N-nitrosodimethylamine (NDMA).
Global  health authorities have also clamped down, with European regulators  last month effectively banning sales of the product, made by Mylan's  India-based unit, in Europe.
The  finished products recalled by Mylan on Tuesday, were manufactured by  its units Mylan Pharmaceuticals Inc and India-based Mylan Laboratories  Ltd and distributed in the United States between March 2017 and November  2018, the company said in a statement.

The U.S. Food and Drug Administration had earlier halted imports of drug  ingredients or medicines containing ingredients produced at a factory  belonging to a Chinese bulk manufacturer of valsartan, Zhejiang Huahai  Pharmaceuticals.

More at: https://www.yahoo.com/news/mylan-rec...--finance.html

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## pcosmar

> So should government regulate what is allowed in medicines?


NO

That is the consumers responsibility.

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## Zippyjuan

> NO
> 
> That is the consumers responsibility.


How do you find out what is in every medicine on the market?  Do you take the time to look them up before you purchase anything?

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## donnay

> How do you find out what is in every medicine on the market?  Do you take the time to look them up before you purchase anything?


Most people don't because they think the FDA and the CDC are looking out for them.

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## pcosmar

> How do you find out what is in every medicine on the market?  Do you take the time to look them up before you purchase anything?


Why would you want to purchase something you Know Nothing About?

and in the old days we used a Physicians Desk Reference..  combined with our personal Knowledge.

Research and consumer Groups (Watchdogs) produced information..


But people still buy magic beans today

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## Swordsmyth

Another batch of blood pressure drugs have been recalled over fears they contain traces of a cancer-causing chemical.  
Valsartan  was originally developed by Novartis, marketed as Diovan, but it is now  off patent and US patients can instead use generic versions from  various companies around the world. 
However,  last summer it emerged some produced in China had been contaminated  with a carcinogen called NDEA, prompting a global recall. 
And  now, US regulators say an Indian generic drugmaker, Aurobindo Pharma  Ltd, will recall 80 lots of medicines containing the blood pressure drug  for the same reason.


In addition to tackling high blood pressure, it is also prescribed to treat heart failure. 
The  impurity NDEA (N-Nitrosodiethylamine) was detected in quantities above  the acceptable limit in certain tablets containing valsartan, the FDA  said.
The announcement comes a month  after Mylan NV said it will recall all lots of its blood pressure  medicines containing valsartan after global health authorities clamped  down on the drug.
The FDA said it will  continue to investigate and test all blood pressure drugs for the  presence of NDEA and another probable carcinogens.


More than two-thirds of all active drug ingredients originate in China and India, industry experts estimate.
This case shows, yet again, how heavily consumers around the world rely on medicines made in India and China.

More at: https://www.dailymail.co.uk/health/a...sartan-US.html

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## Swordsmyth

The  Japanese subsidiary of Pfizer Inc is recalling a drug for high blood  pressure which was found to contain a carcinogenic substance in its  active ingredient valsartan, the drugmaker said on Friday.More  than 763,000 tablets of the drug Amvalo, manufactured from April to  July in Mylan Laboratories Limited in India, are the subject of recall,  Pfizer Japan Inc said in a statement, adding there were no reports of  any damage to health.

More at: https://news.yahoo.com/pfizer-japan-...--finance.html

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## pcosmar

> How do you find out what is in every medicine on the market?  Do you take the time to look them up before you purchase anything?


Yes,, 
Why would you buy something you know nothing about?

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## pcosmar



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## angelatc

> Better ban those too, eh?
> 
> "Traces found".  How much and how much is associated with a cancer risk?
> 
> Study tried to find out:  https://www.bmj.com/content/362/bmj.k3851


It's  a voluntary recall, Zipster.  Settle down.  Just another instance of the private sector taking care of customers, no government required.

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## angelatc

> Why would you want to purchase something you Know Nothing About?


Because I majored in Accounting not Microbiology, so I pay other people for their knowledge like they pay me for mine.

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## Stratovarious

''We have to take it so we can find out what's in it.''

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## pcosmar

> ''We have to take it so we can find out what's in it.''


LOL,, literally

actually,, I have done that in the past.. and learned from it.

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## Stratovarious

> LOL,, literally
> 
> actually,, I have done that in the past.. and learned from it.


lmao, I guess that's what I was doing in HS as well....

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## Stratovarious

I'm out in the garage right now working on a vaccine for this, I'll be 
back if it works........

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## Swordsmyth

Teva Pharmaceuticals this week expanded its recall of losartan potassium tablets after detecting a possible human carcinogen in the blood pressure medication.
The Israel-based drugmaker recalled six more lots of losartan potassium that contained unacceptable levels of a nitrosamine impurity. In April, Teva pulled 35 lots of the drug after detecting the same impurity, N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA.
Teva sold  bulk lots of the drug to California-based Golden State Medical Supply,  which packaged and shipped the medication to pharmacies in bottles that  contain 30, 90 and 1000 tablets, according to a recall notice shared by the U.S. Food and Drug Administration.
Consumers  affected by the recall should continue taking their medication and ask  their doctor or pharmacist about alternatives or replacement drugs.  Discontinuing a medication without a replacement could cause a patient  more harm than continuing the drug.
Since July, two dozen drug companies have recalled hundreds of lots of commonly-prescribed blood pressure and heart medications  losartan, valsartan and irbesartan  after testing revealed some  versions had small amounts of suspected carcinogens. The recalls of the  class of drugs called angiotensin II receptor blockers (ARBs) have  highlighted the complex international drug supply chain with 80% of drug  ingredients consumed by U.S. residents made at factories overseas.


Teva said in its recall notice the NMBA impurity was traced  to ingredients made at Hetero Labs Limited in India, a factory linked to  multiple recalls. The FDA and European drug regulators first traced the  carcinogen-tainted ingredients last July to Zhejiang Huahai  Pharmaceutical in Linhai, China,

More at: https://news.yahoo.com/blood-pressur...220615313.html

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