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Several common medications containing valsartan, used to treat high blood pressure and heart failure, have been recalled in the United States because of an "impurity" drug that presents a potential cancer risk .
This impurity, N-nitrosodimethylamine or NDMA, is clbadified as probable carcinogen for humans, depending on the results of laboratory tests.
Drugs included in the voluntary recall are Major Pharmaceuticals' valsartan, Solco Healthcare and Teva Pharmaceuticals Industries, as well as Solco and Teva's valsartan / hydrochlorothiazide.
The medications that were recalled on October 24 are sold by Teva Pharmaceuticals, Major Pharmaceuticals, Prinston Pharmaceutical Inc., called Solco Healthcare LLC, Teva Pharmaceuticals USA and named Actavis, AvKARE (Teva / Actavis), RemedyRepack Inc. (Prinston / Solco), AS Medication Solutions LLC (Teva / Actavis and Prinston / Solco), Bryant Ranch Prepack Inc. (Teva / Actavis), HJ Harkins Company Inc. dba Pharma Pac (Prinston / Solco), Northwind Pharmaceuticals (Teva / Actavis) , Hetero Labs, Inc. known as Camber Pharmaceuticals, Inc., NuCare Pharmaceuticals Inc. (Prinston / Solco), RemedyRepack, Inc. (Straight / Camber), AvKARE (Straight / Camber), Preferred Pharmaceuticals, Inc. (Straight / Camber) , Torrent Pharmaceuticals Limited and RemedyRepack, Inc. (Torrent).
Additional information on recalled products, including doses, lot numbers and expiry dates, is detailed on the FDA website.
Valsartan no longer has a patent and is used as a component of other generic drugs, but all drugs containing the ingredient are not concerned with the booster.
The US Food and Drug Administration said in a press release that "the presence of NDMA was unexpected" and would be linked to changes in the way the active substance was manufactured.
"Our team of drug shortages is also working hard to ensure that patients' therapeutic needs are met in the United States with an adequate supply of unaffected drugs," said Dr. Scott Gottlieb, FDA Commissioner, in his report. communicated.
The FDA action took place after 22 other countries had recalled 2,300 lots of valsartan sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium , France, Poland, Croatia and Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.
Since the recall in the United States, some patients taking drugs containing valsartan are wondering what to do about their regimen.
"Their biggest concern is about their risk of cancer and how they should be affected," said Dr. Suzanne Steinbaum, Director of Cardiovascular Disease Prevention, Health and Wellness in Canada. Mount Sinai in New York and spokesman for the American Heart Association.
"They are asking if there are any tests that should be done." Patients are now asking if they should only ask for brand name drugs rather than generic drugs to make sure this does not happen. Finally, they all want to stop treatment, "Steinbaum said, noting that it was not the right action to take.
The experts offered four take-away meals to patients following the recall.
All drugs based on valsartan do not have any impurity
Generally, all drugs containing valsartan are not included in the recall as all drugs containing valsartan were not supplied with the supply of valsartan related to the "impurity" of the NDMA.
Since the recall, the external supplier related to the problem has stopped distributing its ingredient to valsartan, and the FDA is working with the companies involved to reduce the risks that such a recall will occur in future products, according to the company. agency.
In the meantime, "there are other drugs containing valsartan, some in combination with amlodipine, and these do not seem to be part of the recall," said Dr. Gregory Prokopowicz, Director of the Johns Hopkins Hypertension Center and Assistant Professor of Medicine. at the Johns Hopkins University School of Medicine.
Amlodipine can be used alone or in combination with other medicines to treat high blood pressure and chest pain.
"It is also important to know that the drug Entresto, manufactured by Novartis and containing valsartan and sacubitril and intended for heart failure, is not concerned with the recall," he said. . "So patients taking this medication should not stop their treatment."
The recall does not involve any Novartis or Sandoz valsartan product in the United States or any Novartis Pharma product containing valsartan, according to a company statement.
"The valsartan (active pharmaceutical ingredient) contained in these products does not come from the same source as the products affected outside the United States," the statement said, recalling that specific batches of Sandoz valsartan and Sandoz hydrochlorothiazide film-coated tablets have been recalled. outside the United States this month.
In the United States, patients taking valsartan, Diovan, Diovan HCT, Exforge, Exforge HCT or Entresto should continue to follow their doctor's recommendations, the statement said.
The FDA noted that patients should consult the name of the drug and the company name on the labels of their drug vials to determine if their drug has been recalled. If the information is not on the bottle, patients should contact their pharmacy for this information.
Alternatives to valsartan are available
"Patients taking the recalled medicines containing valsartan should consult their doctor or pharmacist and continue to take their medication until they have a substitute," said Steinbaum.
"The drug treatment conditions – heart failure and high blood pressure – are serious and patients could be harmed if they suddenly stopped taking it without a replacement order," she said.
A health professional may be able to help you provide information on other products that contain valsartan or other treatment options.
Patients "could switch to another generic manufacturer.They could also use another drug belonging to the same clbad of drugs.This clbad of drugs is known as angiotensin receptor blockers, or ARA, "said Prokopowicz.
"There are eight medications on the market in this category.Therefore, there are a number of drugs they could be substituted for, other than valsartan.Examples are losartan, irbesartan, olmesartan, and several others, "he said. "In addition to ARA medications, there are many other antihypertensive medications that can easily replace valsartan safely, even outside of this category, so it varies from one patient to another."
Patients who have switched to another medication should carefully monitor their blood pressure, said Dr. Erin Michos, Associate Professor and Associate Director of Preventive Cardiology at Johns Hopkins Medicine.
"Their blood pressure may react differently to the new drug and the doses of these medications may be adjusted under the supervision of their health care provider," said Michos, whose own patients asked him about the drug. reminder of valsartan.
"Whenever I change or modify new blood pressure medications, I recommend that patients keep a diary of their blood pressure numbers and the time the action was taken, and share this diary with their health care provider for it to review and adjust, "she said. "Most of the time, I'm replacing my valsartan patients with another ARA – it's the simplest solution."
What is the risk of valsartan cancer?
For now, the long-term risks posed by NDMA in some drugs containing valsartan remain largely unknown and the amount of NDMA consumed would play a role in these risks, said Michos.
In other words, "the dose produces the poison," she said.
"What we know about the dangers of this impurity comes mainly from laboratory studies.This is a toxin that can affect the liver and cause fibrosis or scarring of the liver and tumors. of the liver in the rat, so it is supposed to be toxic to humans, "Michos said.
"In these animal studies, they usually give large amounts, so again, the risk is probably not the same as in humans," she said.
NDMA, an organic chemical found in industrial and natural processes, has been used for the production of liquid fuels, softeners and lubricants. It can also be produced unintentionally during certain chemical reactions and is a by-product of the manufacture of certain pesticides, the manufacture of rubber tires or the processing of fish.
According to the US Environmental Protection Agency, exposure to high levels of NDMA can cause liver damage in humans.
"I am definitely moving my patients out of this drug if they are provided by one of the affected companies," Michos said. "I'm certainly worried, but I think it's too early to panic.This reminder is a safety precaution."
To put the recall in perspective, Dr. Howard Weintraub, a cardiologist and professor of medicine at NYU Langone Health, said he spoke to his patients about a meta-badysis study on receptor antagonists in the US. angiotensin in general and the risk of cancer.
This study, published in the journal Medicine in 2016, included the badysis of data from 19 randomized controlled trials involving 148,334 patients.
"Looking at all the trials conducted with a variety of these drugs in the ARA family, there was no indication of a cancer risk," said Weintraub, who did not participate in the study.
"It was a very successful badysis of old tests, and there was no ambiguity about the lack of cancer risk signal," he said. he declares.
"Taking drugs does not replace a good lifestyle"
Overall, the conversation around drugs containing valsartan is a reminder for patients to be alert to maintaining healthy habits and their drug regimen, Weintraub said.
It's important to continue taking prescriptions from your doctor, but "taking medication does not replace a good lifestyle," he said.
"You and your doctor or health practitioner have to work together to pay attention to your weight, monitor your diet, especially your salt intake, and try to exercise regularly," he says. declared. "Each of these individually and together can have a significant impact on your blood pressure."
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