This impurity, N-nitrosodimethylamine or NDMA, is classified as possibly carcinogenic to humans, based on laboratory test results.
Valsartan is a non-patent medicine, but not all drugs containing "Our drug shortage team also strives to meet the therapeutic needs of patients in the United States by providing them with adequate medications", said Dr. Scott Gottlieb, Commissioner of the FDA, in a statement. declaration.
Amlodipine can be used alone or in combination with other drugs to treat lymphatic arthritis. high blood pressure and chest pain.
"It is also important to know that the drug Entresto – – is made by Novartis which contains valsartan and sacubitril and is for heart failure – is not affected by the remember, "he said." Patients taking this medication should not stop their medication. "
Recall does not affect Novartis or Sandoz valsartan products in the United States or Novartis Pharma products containing of valsartan, according to a statement from the company. [19659004Rappeld] a medicament for cardiovascular disease in 22 countries for a possible placement with the campaign "data-src-mini =" // cdn.cnn.com/cnnnext/dam/assets/111107161021-blood-pressure-small-169.jpg " data-src-xsmall = "// cdn.cnn.com/cnnnext/dam/assets/111107161021-blood-pressure-medium-plus-169.jpg" data-src-small = "http: //cdn.cnn. com / cnnnext / dam / assets / 111107161021-blood-pressure-large-169.jpg "data-src-medium =" // cdn.cnn.com/cnnnext/dam/assets/111107161021-blood-pressure-exlarge-169 .j pg "data-src-large =" // cdn.cnn.com/cnnnext/dam/assets/111107161021-blood-pressure-super-169.jpg "data-src-full16x9 =" // cdn.cnn.com/ cnnnext / dam / assets / 111107161021-blood-pressure-full-169.jpg "data-src-mini1x1 =" // cdn.cnn.com/cnnnext/dam/assets/111107161021-blood-pressure-small-11.jpg "data-demand-load =" not-loaded "data-eq-pts =" mini: 0, xsmall: 221, small: 308, medium: 461, large: 781 "src =" data: image / gif; base64, R0lGODlhEAAJAJEAAAAAAP /////// wAAACH5BAEAAAIALAAAAAAQAAkAAAIKlI + py + 0Po5yUFQA7 "/>
" The API valsartan (19659016) " Active Pharmaceutical Ingredient) does not come from the same source. According to reports, specific batches of Sandoz valsartan and Sandoz valsartan and hydrochlorothiazide film-coated tablets were recalled outside the United States this month.
Patients in the United States who are taking these drugs at valsartan or Diovan, HCT Diovan, Exforge, Exforge HCT or Entresto should continue as directed by their physicians, the report said.
The FDA noted that patients should look at the name of the drug and the name of the company on the labels of their prescription vials to determine if their drug has been recalled. If the information is not on the bottle, patients should call their pharmacy for these details.
Alternatives to valsartan are available
"Patients taking the recalled valsartan medications should consult their physician or pharmacist, and continue to take their medications until the date is reached. they have a substitute, "said Steinbaum.
" The conditions of drug treatment – heart failure and high blood pressure – are serious and patients could be injured if they suddenly stop taking it without a substitute prescription "
A health professional could help provide information on other products containing valsartan or other treatment options.
Patients" could switch to another generic drug manufacturer, or they could switch to another drug of the same class of drugs. "There are eight drugs on the market in this category, so there are a number of drugs that they can substitute for, aside from valsartan, for example losartan, irbesartan, olmesartan, and there are several more, "he said." In addition to ARB drugs, there are many other blood pressure medications that can be easily and safely substituted for valsartan, even outside this category, what varies from one patient to another. "
According to Erin Michos, associate professor and associate director of preventive cardiology at Johns Hopkins Medicine, it is possible that their blood pressure responds differently to the new drug and at doses, "said Michos, whose own patients asked him questions about the recall of valsartan.
" Whenever I change or adjust new blood pressure medications, I recommend Patients keep a logbook. With their blood pressure numbers and time of day, the action was taken, and share this diary with their health care provider to review and make adjustments, "she said. "I'm just transferring my patients from valsartan to another ARA, it's the simplest solution."
What is the risk of valsartan cancer?
To date, the long-term risks posed by NDMA found in certain drugs containing valsartan remain somewhat unknown, and the amount of NDMA consumed would play a role in these risks, said Michos.
In other words, "the dose is poisonous," she says.
"What we know about the dangers of this impurity comes mainly from laboratory studies: it is a toxin that can affect the liver and cause liver fibrosis and scarring. "In these animal studies, they usually give large amounts, so again, the risk is probably not the same in humans," said Michos
. ", did she say.
NDMA, an organic chemical and natural processes, has been used to make liquid fuels, softeners and ants lubricants, among other products. It can also be unintentionally produced by certain chemical reactions and is a byproduct of the manufacture of certain pesticides, the manufacture of rubber tires or fish processing.
Exposure to high levels of NDMA can cause liver damage. Agency:
"I am definitely changing my patients to this medicine if it is provided by one of the affected companies," Michos said. "I'm definitely worried, but I think it's too early to panic. This reminder is a safety precaution."
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To put the recall into perspective, Dr. Howard Weintraub, a cardiologist and NYU Langone Health professor of medicine, said that he told his patients a meta-analysis about receptor blockers of the 39, angiotensin in general and the risk of cancer.
This study, published in the journal Medicine in 2016, involved the analysis of data from 19 randomized controlled trials involving 148,334 patients. In all those trials that were conducted with a variety of these drugs within the ARB family, there was no indication of a cancer risk, "said Weintraub, who did not not participated in the study.
"It was a very good … done analysis of older tests, and there there was no ambiguity that it was. there was not a signal of cancer risk, "he said.
" Taking drugs does not replace a good lifestyle "
In the 39 together, drugs containing valsartan "recalls Weintraub
It is important to continue taking medications prescribed by your doctor, but" taking medication does not replace a good lifestyle. "
"You and your doctor or health practitioner should work together to make sure you are watching your weight, watch your diet, especially your salt intake, and try to exercise regularly. " "Each of those individually and together can have a significant impact on your blood pressure."
