FDA Recalls Common High Blood Pressure/Heart Failure Drug due to Cancer Risk!

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Luckily I don't take any of these prescription drugs for high blood pressure/heart failure, but maybe some others here do. More here.

(CNN) — 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.

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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Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level.

This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product lots.

This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

The products are indicated for the treatment of hypertension.
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SOURCE


 

You're welcome rgp, good idea to get in touch with your doctor or pharmacy asap.
 

Update: I talked with my pharmacist and yes mine is recalled!! He said it was the manufacturer (Soloc China) that is the fault! He is searching for a US Manufacturer and will call me. He said not to stop talking it. The next alternative would be for my doctor to change my drug or dosage..
 
Thanks for the added info Ken, hoping they can give you something else not just lessen your dosage.
 
It's bad enough that most of these prescription drugs have serious side effects....but, now if a drug company is "outsourcing" it's manufacturing to China, who Knows What kind of "waste" might be included in the pills. I guess Making Money is more important to the drug companies, than "quality control".
 
Don M. said:
It's bad enough that most of these prescription drugs have serious side effects....but, now if a drug company is "outsourcing" it's manufacturing to China, who Knows What kind of "waste" might be included in the pills. I guess Making Money is more important to the drug companies, than "quality control".
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It is always about the money unfortunately. I already acknowledged the red flag many years ago about feeding chicken jerky treats from China to my dogs, now it's USA ingredients and manufacturing only for my pets.

Ultimately, I hold the FDA responsible, they should have the health of Americans in mind when they approve any drugs and drug manufacturers, from past history that doesn't seem to be the case, they approve drugs just to get them on the market to make money from them. The quality of the medications and side effects including death, take second place in priorities. Just read this letter regarding company that made this drug, and found it interesting...here.

Warning Letter: 320-16-06​

Via UPS

December 31, 2015

Mr. Hua Bai, CEO
Zhejiang Hisun Pharmaceutical Co., Ltd.
46 Waisha Road
Jiaojiang District
Taizhou City, Zhejiang Province
China 318000

Dear Mr. Bai:


From March 2-7, 2015, investigators from the U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Hisun Pharmaceutical Co., Ltd., 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province.


We identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (API).

These deviations cause your drugs to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your March 27, 2015 response in detail and acknowledge receipt of subsequent responses.

Our investigators observed specific deviations during the inspection, including, but not limited to, the following.
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Called my doc, they say they just did get the recall. But varying manufactures produce it. They are checking sources & will get back to me today.

Called the pharmacy , they too just became aware of the recalls, but claim that the manufacturer [Macleods] of the one I take is not part of the recall. And that it is OK to continue taking it.....

Just an opinion but.......sure seems our suppliers should know about this sort of thing , well before we do?
 
I wonder how many different manufacturers are putting out this drug? Seems several names have been flying around in the two articles I cited above.
 
All this is just another example of why I am leery of most things medical. I sometimes feel the best ingredient we can hope for is plain ol' good luck. If it misses us?...we can be in serious trouble.
 
Damn! I'm on Valsartan too. Guess I'd better contact my doctor and pharmacy too. My doctor is going on vacation for two weeks, maybe starting tomorrow but his office has coverage. Thank you for this post! I'm going to share it on another site in the medical discussion group I'm in.
 
Recall expanded

More here.

(CNN)The US Food and Drug Administration says another heart medicine is being voluntarily recalled after tests showed that it was tainted with a potential cancer-causing chemical.

The new recall of losartan potassium hydrochlorothiazide is sold by the company Sandoz. The voluntary recall only involves the 100 milligram/25 milligram tablets, it does not involve the other versions of the drug, sometimes sold under the brand names Hyzaar.

If you take Sandoz's losartan potassium, look on the bottle for the lot number. If it has the lot number JB8912, then you have the recalled pills. Patients use these drugs to keep their high blood pressure in check.

The drug is being recalled because the active ingredient has tested positive for N-Nitrosodiethylamine or NDEA, a suspected human and animal carcinogen that is used in gasoline as a stabilizer for industry materials and as a lubricant additive, according to the National Institutes of Health.

The ingredient was made by Zhejiang Huahai Pharmaceutical Company Co. Ltd. The FDA placed the Chinese company on an import alert at the end of September, meaning all of its active pharmaceutical products and finished products will not be permitted to enter the United States. The FDA made that decision after an inspection of the facility.


Several pills that contain valsartan, another drug used by heart patients, have been under a recall since July. The drugs were tainted with NDEA or NDMA, N-nitrosodimethylamine, an impurity that is also considered a possible carcinogen by the US Environmental Protection Agency.

NDMA is an organic chemical used to make liquid rocket fuel and is a byproduct of manufacturing some pesticides and processing fish. It can be unintentionally introduced into manufacturing through certain chemical reactions.


The FDA is testing all heart drugs known as ARBs for these impurities.


Not all medicine containing valsartan is recalled. The FDA keeps an ongoing list of products that are recalled and a list of the valsartan products that are not recalled.

The latest recall impacts less than 1% of the total losartan drug products in the US market, according to the FDA.


If your drug is on the recall list, the FDA suggests taking it until your doctor or pharmacist provides a replacement. Because not all valsartan and irbesartan drugs are involved in the recall, you might be able to switch to a version by another company.
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In the news again today, more here.

A Food and Drug Administration recall of a heart medication due to a cancer-causing chemical now includes two blood pressure medications.

Teva Pharmaceuticals has issued a voluntary recall of its amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets, both used to treat high blood pressure, according to the FDA.

The move is due to the detection of a probable human carcinogen known as NDEA, which has been found in valsartan API, the FDA said.

Valsartan API is an active pharmaceutical ingredient made by Mylan India, according to the FDA.

“This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes,” the FDA said in a news release.
The FDA said Teva has so far not received any reports of adverse events "signaling a potential link or exposure" to valsartan.

Patients who take either tablets were advised to continue their medication and to reach out to their pharmacist or doctor for further information on an alternative treatment.

“The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment,” the FDA said.
When reached for comment, a Teva spokesperson pointed ABC News to the FDA announcement and that of Mylan on Nov. 20.
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