The U.S. Food and Drug Administration issued a voluntary recall on Friday of a drug commonly used to control blood pressure and prevent heart failure.
The drug, valsartan, is often a component of generic medicines, but not all heart medicines that contain valsartan are involved in the recall, the FDA warns.
The recall is due to the presence of an impurity, N-nitrosodimethylamine (NDMA). It is an organic chemical that is often used in rocket fuel, softeners and lubricants.
NDMA is classified as a probable human carcinogen based on lab tests. The FDA believes this sudden presence of NDMA is because of the way the substance was manufactured.
Read Also : What Is NDMA?
Read Also : Valsartan Recall List
Here are some of the companies who are recalling products:
Major Pharmeceuticals
Solco Healthcare
Teva Pharmaceuticals Industries Ltd.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. “This is why we've asked these companies to take immediate action to protect patients.”
The FDA’s investigation into the drugs are ongoing.
Experts warn that patients who are on heart-monitoring medication should talk to their doctor to see if their prescriptions are affected.
Doctors say patients should not stop taking heart medications without a doctor’s supervision, because it could cause a life-ending catastrophe, according to the American Heart Association.
Not only FDA America 22 other country also recall this drug, Drugs for heart disease patients circulating widely in the market should be withdrawn because it contains a dangerous risk. Is valsartan, a drug commonly consumed heart patients, revoked its circulation in 22 countries. After going through a series of studies, known valsartan proved to have a potentially cancerous potential.
Quoted from CNN, Novartis as the producer revealed it has attracted the circulation of Sandoz valsartan and valsartan / HCT film-coated tablets. The withdrawal was made after they discovered that 'the drug has no standardized quality'. In the UK, the pharmaceutical industry was asked to withdraw valsartan drugs made by Dexcel Pharma Ltd and Accord Healthcare.
Massive withdrawals also occur for drugs already sent to several European countries. The list of countries is Germany, Norway, Finland, Sweden, Hungary, Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece. Canada, Bosnia and Herzegovina, Bahrain, and Malta are also included in countries exposed to valsartan circulation.
Nevertheless, Novartis spokesman Eric Althoff said products sold in the United States were not withdrawn. Sandy Walsh, a spokeswoman for The US Food and Drug Administration, said the pharmaceutical agent was aware of the situation but declined to comment.
The potential dangers of valsartan drugs are revealed in the pharmaceutical valsartan active drug stock (API) stock. Drug tests found the presence of N-Nitrosodimethylamine (NDMA), an organic chemical that is carcinogenic. Animal testing shows NDMA content can cause tumors in the liver, kidneys, and respiratory system. The same effect will be experienced by humans when taking drugs in certain amounts.
Read Also : What Is NDMA?
Read Also : Valsartan Recall List
The recall is due to the presence of an impurity, N-nitrosodimethylamine (NDMA). It is an organic chemical that is often used in rocket fuel, softeners and lubricants.
NDMA is classified as a probable human carcinogen based on lab tests. The FDA believes this sudden presence of NDMA is because of the way the substance was manufactured.
Read Also : What Is NDMA?
Read Also : Valsartan Recall List
Here are some of the companies who are recalling products:
Major Pharmeceuticals
Solco Healthcare
Teva Pharmaceuticals Industries Ltd.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. “This is why we've asked these companies to take immediate action to protect patients.”
The FDA’s investigation into the drugs are ongoing.
Experts warn that patients who are on heart-monitoring medication should talk to their doctor to see if their prescriptions are affected.
Doctors say patients should not stop taking heart medications without a doctor’s supervision, because it could cause a life-ending catastrophe, according to the American Heart Association.
Not only FDA America 22 other country also recall this drug, Drugs for heart disease patients circulating widely in the market should be withdrawn because it contains a dangerous risk. Is valsartan, a drug commonly consumed heart patients, revoked its circulation in 22 countries. After going through a series of studies, known valsartan proved to have a potentially cancerous potential.
Quoted from CNN, Novartis as the producer revealed it has attracted the circulation of Sandoz valsartan and valsartan / HCT film-coated tablets. The withdrawal was made after they discovered that 'the drug has no standardized quality'. In the UK, the pharmaceutical industry was asked to withdraw valsartan drugs made by Dexcel Pharma Ltd and Accord Healthcare.
Massive withdrawals also occur for drugs already sent to several European countries. The list of countries is Germany, Norway, Finland, Sweden, Hungary, Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece. Canada, Bosnia and Herzegovina, Bahrain, and Malta are also included in countries exposed to valsartan circulation.
Nevertheless, Novartis spokesman Eric Althoff said products sold in the United States were not withdrawn. Sandy Walsh, a spokeswoman for The US Food and Drug Administration, said the pharmaceutical agent was aware of the situation but declined to comment.
The potential dangers of valsartan drugs are revealed in the pharmaceutical valsartan active drug stock (API) stock. Drug tests found the presence of N-Nitrosodimethylamine (NDMA), an organic chemical that is carcinogenic. Animal testing shows NDMA content can cause tumors in the liver, kidneys, and respiratory system. The same effect will be experienced by humans when taking drugs in certain amounts.
Read Also : What Is NDMA?
Read Also : Valsartan Recall List
Causing Cancer, FDA & 22 Other Country Recall Common Drug
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