FDA Recalls Common Heart Drug For Potential Cancer Risk

CBS ^ | 7/16/2018 | Jen Christensen

[sodpoodle]

The recall of a common drug used to control blood pressure and help prevent heart failure was announced by the US Food and Drug Administration on Friday, a week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk. Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA.

The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

[sodpoodle]

Check your prescriptions!!!

[EQAndyBuzz]

I’m screwed! Been taking it for several years.

[catnipman]

bad news ... but valsartan itself is OK ... generic versions (including combo drugs) have manufacturing impurities that cause cancer ...

[catnipman]

“I’m screwed! Been taking it for several years.”

only if you’ve been taking a generic ...

[Mariner]

There’s probably 10 million Americans taking HCTZ (Diuretic). But, buy far, most of them ARE NOT taking the HCTZ with Valsartan.

[rlmorel]

People need to be careful about this. I honestly pay little attention to these types of things, expecially when you read the text. Here is the text from the article:

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"...The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, according to an FDA statement. NDMA is an organic chemical that is in a family of potent carcinogens. It has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.

Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen, according to the US Department of Health and Human Services.

Novartis spokesman Eric Althoff said after the initial recall last week that products sold in the US were not affected by this recall, but the FDA’s ongoing review and laboratory tests found otherwise. “The presence of of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” the FDA release said.

“The amounts of NDMA found in Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA,” Althoff wrote in an email July 6. “There is no certainty as to how much this contaminant may potentially increase cancer risk in humans. Thus, the amount of NDMA found in the Valsartan API would not represent a significantly increased risk to the patients taking of Sandoz Valsartan and Sandoz Valsartan HCT Film coated tablets.”

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So...you get more exposure to it just walking around and existing, or having your body produce it at some level (which it sounds like it must, otherwise why would it say that? Granted that is from Novartis and should be taken with a grain of salt as well.

Thing is, if you have heart failure and are taking HCTZ, there may be a better alternative, or there may not be. Your risk of going into heart failure far, Far, FAR outweighs any apparent cancer risk, if I read the text of this correctly.

Good to be cautious about these kinds of things.

[Eleutheria5]

If you got it, call a lawyer.

[Red Badger]

THAT’S MY STUFF!...................

[rlmorel]

One more thing-even though taking one of these drugs could at most potentially double your exposure to what you normally get, that doesn’t mean it doubles your risk.

Think of it like radiation.

They don’t have a threshold level under which you are safe, or over which you are screwed (excepting concepts like the LD50 dosage (in which 50% of a population exposed at that level may die in 30 days, but...in that other 50%, some may live to the age of 100 with no long term effects)

[stylecouncilor]

Ping

[oblomov]

Original brand name = Diovan

[Grampa Dave]

Thing is, if you have heart failure and are taking HCTZ, there may be a better alternative, or there may not be. Your risk of going into heart failure far, Far, FAR outweighs any apparent cancer risk, if I read the text of this correctly.

My grandparents were on this drug decades ago and so were my parents. They lived into their 80’s with no cancer.

[ifinnegan]

Everyone should read rlmorel’s post 6.

Realize this is precautionary.

[PapaBear3625]

It’s not valsartan itself, but rather impurities found in batches made by five particular manufacturers. You should check if your prescription came from one of the list in the link below.

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

[i_robot73]

Wow, it’s a good thing we have an (illegal/anti-A1S8) FDA to protect the People before these types of drugs get Rx’d

Wait. What?!

Never mind.

Sure isn’t those HURT getting anything from any of the trials that’ll soon sprint up either.

[EQAndyBuzz]

“only if you’ve been taking a generic ...”

Yes, I am taking the generic.

[Sans-Culotte]

I take Valsartan/HCT; have for years. According to my bottle from OptumRX, mine is made by Mcleods.

[EQAndyBuzz]

Just got off the phone with my pharmacist. I’m clear.

[onedoug]

Auribindo not mentioned.
I’d expect to get a letter from my doc shortly.

[lonevoice]

bkmk