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Two Million People Have Been Exposed to Carcinogenic Chemicals in Contaminated Blood Pressure Drugs, According to US Regulators
- Last summer, it became apparent that widely prescribed drugs for heart failure and hypertension had dangerously high levels of recognized carcinogens.
- Drugs include valsartan, losartan and irbesartan
- More than one million people affected are in the United States, announced today the FDA
- The FDA has stated that chemicals have emerged as a byproduct of other chemicals accidentally mixing together
By
Mia De Graaf Health Editor For Dailymail.com
published:
6:37 pm EST, January 25, 2019
|
Update:
6:37 pm EST, January 25, 2019
At least two million people in the world have been exposed to carcinogenic chemicals that have altered the blood pressure drugs made in China, the FDA announced today.
More than one million people affected are in the United States, which is heavily dependent on China for its pharmaceutical ingredients.
Last summer, many medications widely prescribed for the treatment of heart failure and high blood pressure, including valsartan, losartan, and irbesartan, had dangerously high rates of carcinogens, NDEA and NDMA, well above the limit set by US legislation.
This caused a global recall that lasted seven months – and it is only now that the FDA publishes details on how this happened and how much was affected.
Expressing its findings on Friday, the FDA downplayed the exposure, insisting that despite finding levels of carcinogens above the legal limit, the risk of developing cancer was not high, compared to the cancerous byproducts that appear when you grill meat.
However, health policy experts believe that the situation is much more worrying than what regulators are willing to concede – for the millions of people at risk and exposing America's imbalanced relationship with the China.
In the summer of 2018, it was discovered that valsartan produced in China was contaminated with a carcinogen called NDEA, which resulted in a worldwide recall. Months later, more drugs are still recalled
FDA inspectors claim to know now how carcinogenic chemicals end up in millions of antihypertensive drugs, which has triggered a worldwide recall and desperate shortage.
The impurities found in some of the most requested medications for heart failure and hypertension are a byproduct that appears when certain active ingredients are mixed.
If the drugs are made according to the "recipe", there should be no risk of this by-product occurring.
The problem, say the experts, is that the supplier of Zhejiang Huahai Pharmaceutical Co, located in Linhai, China, may not have been completely cleaned up or invested in tools for screening these contaminants.
The FDA insists that it would have been impossible for its inspectors to detect such a problem because they can not search for a specific byproduct and do not know which materials are inadvertently mixed.
While shortages are hitting the United States, Europe and even India (which is the second largest producer of drugs after China), it is becoming increasingly clear that most of the world depends heavily China without being able to control, inspect or coordinate quality. .
"I think the FDA is losing influence on China in terms of inspection," ChinaRx co-author Rosemary Gibson told DailyMail.com. the agency for several months. the country in 2014 and 2015.
& # 39; They [China] wanting to make the work of the FDA difficult. Why do we allow this?
But Gibson says the FDA should not become the scapegoat for this story.
We must examine how China has been allowed to exert such influence on global drug supply and badyze all controllers capable of moving this pendulum.
Take the 2001 anthrax attacks: America had to ship antibiotics from China. If such a crisis recurred and it coincided with any kind of trade war or political struggle, this could be a significant problem.
"China is quickly preparing to become the world's best-selling pharmacy," warns Gibson.
"I see the centralization of our global supply chain in one country very quickly, which will increase the risk of scarcity.
"If we are organizing a global public health event, you do not want to rely on one country."
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