Another Heart Medicine Was Just Recalled For Containing A Likely Carcinogen

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

Quote:

---

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

Quote:

---

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

---

Quote:

---

Originally Posted by Zippyjuan

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.:rolleyes:

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

Quote:

---

Originally Posted by Swordsmyth

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

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

---

"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.

Blood pressure medicine recall expands amid cancer concerns

Quote:

---

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.

If this sounds familiar, it’s because the FDA recently recalled blood pressure drug irbesartan for the exact same reason. That product callback followed on another NDEA-related drug recall, for another blood pressure medication, valsartan, back in July.

As with previous recalls, the FDA cautions that if you take these hypertension medications, it is important to consult a pharmacist or physician before discontinuing use of the drug, as that may have even more severe effects than taking a contaminated pill.

---

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

Quote:

---

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.

Patients taking either drugs should contact their doctor or pharmacist for advice or alternative treatments. Stopping the drugs immediately with no comparable alternative could pose a greater risk to patients' health, said Teva.

More: Doctors: Blood pressure drug substitutes are available for patients affected by recalls

More: FDA chief: Blood pressure medicine recalls reflect increased scrutiny on drug safety

More: Want more news like this? Subscribe to get the Daily Briefing in your inbox.

Customers and patients with questions can contact Teva by phone at 888-838-2872, or email at druginfo@tevapharm.com.

In August, the FDA announced an expanded recall of valsartan because products may contain the impurity. Last month, two more recalls were announced: one for the drug irbesartan and a second recall for losartan potassium hydrochlorothiazide tablets.

During an interview in November with USA TODAY, FDA commissioner Scott Gottlieb said the blood pressure drug recalls reflect an increased focus on drug quality to ensure no impurities are present.

---

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

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?

Quote:

---

Originally Posted by 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?

---

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

Quote:

---

Originally Posted by donnay

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.

Quote:

---

Originally Posted by Zippyjuan

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.

Quote:

---

Originally Posted by donnay

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.

Quote:

---

Originally Posted by Zippyjuan

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.

Quote:

---

Originally Posted by donnay

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

With liberty there are always risks.

---

With everything there are risks.

Quote:

---

Originally Posted by Zippyjuan

With everything there are risks.

---

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

Quote:

---

Originally Posted by Zippyjuan

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.

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

Quote:

---

Originally Posted by Zippyjuan

So should government regulate what is allowed in medicines?

---

NO

That is the consumers responsibility.

Quote:

---

Originally Posted by pcosmar

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?

Quote:

---

Originally Posted by Zippyjuan

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.

Quote:

---

Originally Posted by Zippyjuan

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

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

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

Quote:

---

Originally Posted by Zippyjuan

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?

https://www.youtube.com/watch?v=ffZUHWG66EA

Quote:

---

Originally Posted by Zippyjuan

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.

Quote:

---

Originally Posted by pcosmar

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.

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

Quote:

---

Originally Posted by Stratovarious

''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.

Quote:

---

Originally Posted by pcosmar

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....:frog: