Yet another brand of blood pressure medication has been recalled for carcinogenic infection, the US Food and Drug Administration (FDA) announced Wednesday.
Unsafe levels of the chemical NMBA were found in two types of losarton tablets made by Macleods Pharmaceuticals, a New Jersey-based maker of nearly 100 common drugs.
With this recall of 32 many of the pills, there are now a total of 1,109 entries on the FDA's huge list of contaminated drugs.
The agency urges patients to continue taking their medication, even if they are infected, until their pharmacy can offer a replacement.
But there are now only 43 untouched brands of losartan, valsartan and irbestartan – and pharmacies are already struggling with shortages in the major recall campaigns.
The US and Europe have suffered serious cardiac medication deficits since last summer when millions of people were taking pills made in China along with carcinogenic chemicals
The memory of the Macleods comes just two weeks after the FDA found a fourth carcinogen in the American range of blood pressure products.
The US and Europe have been suffering from serious shortages of heart medication since last summer, when millions of people (at least one million Americans and another million in Europe) were taking pills containing carcinogenic chemicals.
The chemicals could be traced back to shortcomings in quality control in factories in China and India, which produce two-thirds of the ingredients for medicines in the world cheaply and efficiently.
Officials and pharmaceutical companies were forced to get most of the heart drugs from the US, allowing millions of people to choose between contaminated drugs or nothing.
Earlier this year, the US Food and Drug Administration (FDA) published a list of safe alternatives, when the deficit was still falling.
But today, a new FDA application shows that these are also contaminated with another, previously undiscovered chemical: dimethylformamide (DMF), a solvent used in plastics, pesticides and synthetic leathers.
HOW CARCINOGEN IN THE US DRUG FOOD HAVE GOT
In January 2019, FDA inspectors released a report on how cancerous chemicals ended up in millions of blood pressure drugs, leading to a worldwide recall and desperate shortages.
The impurities in some of the most in-demand drugs for heart failure and hypertension are a by-product that appears when certain active ingredients are mixed together.
If the medicines are according to the & # 39; prescription & # 39; be made, there must be no risk of this by-product arising.
The problem, the experts say, is that the supplier in Linhai, China, Zhejiang Huahai Pharmaceutical Co., may not have cleaned itself up or invested in tools to screen these contaminants.
The FDA emphasizes that it would have been impossible for its inspectors to detect such a problem because they could not look for a specific by-product and they would not know which materials were accidentally mixed together.
The chemical was spotted in many valsartan supplied by various top companies, including Novartis, after testing conducted by Valisure, an online pharmacy.
Valisure presented its findings to the FDA last week and forced the agency to a new mystery about how to work around the problem.
Global authorities have been involved in the sale of certain blood pressure medicines for almost a year.
The drugs – valsartan and losartan, mainly made in China and India – were found to be contaminated with two likely carcinogens: N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA).
European regulators first discovered the infection in the spring of 2018 and have begun to take measures to close the offensive offer. In the summer of 2018, the FDA followed the example.
Generic drug makers such as Mylan NV, Teva Pharmaceutical and Novartis & Sandoz recovered products containing the contaminated ingredients in the fall.
In January, the FDA confirmed that another carcinogenic toxin, N-Nitroso-N-methyl-4-amino butyric acid (NMBA), was identified in 87 many losartan potassium pills made in India.
Checking NDEA, NDMA and NMBA is complicated.
They seem to be a by-product of chemical interactions, although it is not exactly clear which.
It is unclear what the FDA will do in light of the new report.
It is possible that the FDA will return to an earlier strategy: Americans are not worried and continue to use their potentially contaminated drugs, maintaining that the levels of NDEA, NMDA and NMBA are too low to pose a problem.
That attitude raised the eyebrows of doctors and researchers.
Rosemary Gibson, author of ChinaRx: Exposing The Risks Of America & Dependence on China For Medicine, told DailyMail.com in an interview: & # 39; Each Chinese-made tablet had an over 200 times acceptable limit, much more than other recalled products. & # 39;
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