FDA recalls a very long list of Blood pressure medication

[TechHDS]

Was reading the net came across a article about the FDA recalling Blood pressure medication many can lead to cancer. So if anyone is taking blood pressure medication you can go on FDA site and look up to see if your medication is on the recall list.

Mike

 

[Swerd]

Was this the announcement?

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

https://www.nytimes.com/2018/07/16/health/fda-blood-pressure-valsartan.html

 

[TechHDS]

Was this the announcement?

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

https://www.nytimes.com/2018/07/16/health/fda-blood-pressure-valsartan.html

Thanks Swerd for posting the link! that’s the article, I’m good on the one I take.

Mike

 

[TLS Guy]

Yes, the whole thing is a disgrace. I found out about it over a month ago from the AMA morning news. SO that spoilt my breakfast for a start.

Anyhow as usual the Chinese are to blame. All brands except one made in India are affected. This one Chinese manufacturer that supplies the BRAND NAME and the generics, had started using a new method to manufacture Valsartan, an ARB used to treat high BP. The drug was best in class and widely used including by yours truly.

Anyhow the Chinese manufacturer was contaminating the drug with NDMA, which is used by cancer researchers to induce cancerous tumors in laboratory animals.

Worse it seems this contamination likely started February of 2017, so over a year before it was discovered which is another disgrace.

The drugs were recalled and I kept some of mine, and I am trying to find a lab to test them. I don't usually consider suing, but on this occasion I have the urge to, they deserve it.

Pharma is out of control. I just picked up a tube of ointment for early rhinophyma. The pharmacist told me the retail price for this 45 gm (1.5 oz) is $600. This drug was on this evil voucher card system from the manufacturer so they can screw anybody vulnerable and bulk buyer consultants can line their pockets. It is basically a kick back for them and should be made illegal pronto.

 

[TechHDS]

Yes, the whole thing is a disgrace. I found out about it over a month ago from the AMA morning news. SO that spoilt my breakfast for a start.

Anyhow as usual the Chinese are to blame. All brands except one made in India are affected. This one Chinese manufacturer that supplies the BRAND NAME and the generics, had started using a new method to manufacture Valsartan, an ARB used to treat high BP. The drug was best in class and widely used including by yours truly.

Anyhow the Chinese manufacturer was contaminating the drug with NDMA, which is used by cancer researchers to induce cancerous tumors in laboratory animals.

Worse it seems this contamination likely started February of 2017, so over a year before it was discovered which is another disgrace.

The drugs were recalled and I kept some of mine, and I am trying to find a lab to test them. I don't usually consider suing, but on this occasion I have the urge to, they deserve it.

Pharma is out of control. I just picked up a tube of ointment for early rhinophyma. The pharmacist told me the retail price for this 45 gm (1.5 oz) is $600. This drug was on this evil voucher card system from the manufacturer so they can screw anybody vulnerable and bulk buyer consultants can line their pockets. It is basically a kick back for them and should be made illegal pronto.

TLS, It sure scared the hell out of me, I sure hope no complications come from the one you were taken. Your one of the good guys in here I for one have picked up some awesome tips and learned a lot just from your posts. I still believe your system setup is one of the best I have ever seen to date.

Mike

 

[Steve81]

I get to take all sorts of good stuff these days too; fortunately for me I'm taking lisinopril instead of valsartan (not that such a recall gives a high confidence in the manufacturing of other drugs).

 

[TLS Guy]

I get to take all sorts of good stuff these days too; fortunately for me I'm taking lisinopril instead of valsartan (not that such a recall gives a high confidence in the manufacturing of other drugs).

Unfortunately I can't take ACE inhibitors as they make me cough and wheeze.

There obviously needs to be much more random batch testing.

 

[KEW]

What is the incentive for manufacturing drugs in China?
I understand products that involve a high amount of labor where wage rates are a huge cost.
I've never toured a pharmaceuticals plant, but always imagined them to be pretty chemical process oriented without a large amount of manual labor.

I guess I am wondering:
Am I wrong and they do require lots of labor?
Is it relaxed environmental/safety laws that benefit Chinese manufacture?
Is it tax laws that benefit Chinese manufacture?

 

[TLS Guy]

Is it relaxed environmental/safety laws that benefit Chinese manufacture?

Mainly this one: - Is it relaxed environmental/safety laws that benefit Chinese manufacture? Correct answer yes.

 

[TechHDS]

I get to take all sorts of good stuff these days too; fortunately for me I'm taking lisinopril instead of valsartan (not that such a recall gives a high confidence in the manufacturing of other drugs).

Steve81, that’s the one I take, but who know really knows what will come up down the road.
I can only imagine how Doctor’s feel, not knowing they have been prescribing poison to their patients. I can remember my orthopedic surgeon when he did my knee replacement telling me all the sh&t he had to go through just to get paid from the insurance companies.

Mike

 

[speakerman39]

So, Valsartan is the only BP med that is of concern? I take Mavic and have for years. It works like a charm for me. Actually, I take the generic trandolapril. Glad mine is not on the list as I would hate to change. Thanks for the heads up folks!


Cheers,

Phil

 

[Swerd]

Yes, the whole thing is a disgrace. I found out about it over a month ago from the AMA morning news. SO that spoilt my breakfast for a start.

I completely agree. It's a disgrace.

Anyhow as usual the Chinese are to blame. All brands except one made in India are affected. This one Chinese manufacturer that supplies the BRAND NAME and the generics, had started using a new method to manufacture Valsartan, an ARB used to treat high BP.

Yes, the Chinese manufacturers are to blame. They are guilty of arrogance and greed. So are the US companies that import and distribute these contaminated drugs.

Anyhow the Chinese manufacturer was contaminating the drug with NDMA, which is used by cancer researchers to induce cancerous tumors in laboratory animals.

NDMA is a highly toxic chemical used to induce cancers in lab rats. I could look up how much NDMA it takes to do that, but that's not the point. There shouldn't be any NDMA at all in a pharmaceutical drug. And there wasn't until a Chinese manufacturer tried a short cut in the Valsartan synthesis and purification.

Worse it seems this contamination likely started February of 2017, so over a year before it was discovered which is another disgrace.

Pharma is out of control.

The FDA's budget has shrunk so much by the Trump administration that it is unable to perform it's job. This was not an accident of budget cuts, it was deliberately done. The present Secretary of Health & Human Services is a former executive of Lily, a major pharmaceutical manufacturer. It's easy to guess that his agenda has nothing to do with better safety from pharmaceuticals, or fair prices. His goal, as he has said himself, is to grant the entire pharmaceutical industry freedom from regulation. In my opinion, it's criminal.

I have my own health problems that require taking drugs everyday, but I'm thankful I don't suffer from high blood pressure, requiring medication.

 

[Hetfield]

I completely agree. It's a disgrace.
Yes, the Chinese manufacturers are to blame. They are guilty of arrogance and greed. So are the US companies that import and distribute these contaminated drugs.
NDMA is a highly toxic chemical used to induce cancers in lab rats. I could look up how much NDMA it takes to do that, but that's not the point. There shouldn't be any NDMA at all in a pharmaceutical drug. And there wasn't until a Chinese manufacturer tried a short cut in the Valsartan synthesis and purification.
The FDA's budget has shrunk so much by the Trump administration that it is unable to perform it's job. This was not an accident of budget cuts, it was deliberately done. The Secretary of Health & Human Services is now a former executive of Lily, a major pharmaceutical manufacturer. It's easy to guess that his agenda has nothing to do with better safety from pharmaceuticals, or fair prices. His goal, as he has said himself is to grant the entire pharmaceutical industry freedom from regulation. In my opinion, it's criminal.

I have my own health problems that require taking drugs everyday, but I'm thankful I don't suffer from high blood pressure, requiring medication.

That's what deplorables call winning.

Sent from my Pixel using Tapatalk

 

[BoredSysAdmin]

That's what deplorables call winning.

Sent from my Pixel using Tapatalk

I'm so tired of all of this "winning".
My wife is a pharmacist and she heard about this issue from her customers first about month ago or so, and they heard about it after EU banned the sales.
Like i said, I'm tired of the "winning"

 

[Swerd]

I'm so tired of all of this "winning".

Don't forget that thought. Election Day is November 6th.

 

[BoredSysAdmin]

Don't forget that thought. Election Day is November 6th.

In my opinion, if you don't make every single possible effort to vote in this and next one elections = you're as good as traitor in my eyes.

 

[donovapreuss]

Hi! Any update, guys?

 

[Swerd]

As far as I know, the latest relevant info from the FDA was on 28 Feb 2019, more than 3 years ago. I would hope that since then that issue of toxic contaminants in valsartan was cleared up. Ask your MD or pharmacist if they know anything more recent.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan

Here's the text & table in that 28 Feb 2019 valsartan update:

Update [2/28/2019] FDA is posting the updated table of interim acceptable intake limits for nitrosamine impurities to reflect N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) limits, which are the same as those for NDMA.

The agency will use the interim limits below to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug product. FDA is working with industry and international regulators to ensure products entering the market do not contain these impurities, but we are tolerating the impurities below the level established in the table for a short period of time to avoid a possible shortage of ARBs.

Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition.

* The acceptable intake is a daily exposure to a compound such as NDMA, NDEA, or NMBA that approximates a 1:100,000 cancer risk after 70 years exposure.
** These values are based on a drug's maximum daily dose as reflected in the drug label.
*** FDA is temporarily not objecting to losartan with NMBA below 9.82 ppm remaining on the market.