Yet another brand of blood pressure medication has been recalled for carcinogen contamination, the US Food and Drug Administration (FDA) announced Wednesday.
Unsafe levels of the chemical NMBA were found in two types of losarten tablets made by Macleods Pharmaceuticals, a New Jersey-based maker of nearly 100 common medications.
With this recall of 32 lots of the pills, there are now a total of 1,109 entries on the FDA’s massive list of contaminated drugs.
The agency is urging patients to keep taking their medications, even if they are contaminated, until their pharmacy can provide a replacement.
But there are now just 43 untouched brands of losartan, valsartan and irbestartan – and pharmacies are already facing shortages amid the sweeping recalls.
The US and Europe have faced severe shortages of heart medications since last summer, when it emerged that millions of people were taking pills made in China laced with cancer-causing chemicals
The Macleods recall comes just two weeks after the FDA found a fourth carcinogen in America’s supply of blood pressure drugs.
The US and Europe have faced severe shortages of heart medications since last summer, when it emerged that millions of people (at least a million Americans, and another million in Europe) were taking pills laced with cancer-causing chemicals.
The chemicals were traced back to quality control failings at factories in China and India, which cheaply and efficiently produce two-thirds of drug ingredients in the world.
Officials and pharmaceutical companies were forced to pull most heart drugs from the US, leaving millions of people to choose between contaminated drugs or nothing.
Earlier this year, as the shortage dragged on, the US Food and Drug Administration (FDA) released a list of safe alternatives.
But today, a new FDA filing reveals those, too, appear to have been contaminated with another, previously undetected chemical: dimethylformamide (DMF), a solvent which is used in plastics, pesticides, and synthetic leathers.
HOW CARCINOGENS GOT IN THE U.S. DRUG SUPPLY
In January 2019, FDA inspectors released a report on how cancerous chemicals got into millions of blood pressure drugs, prompting a global recall and desperate shortages.
The impurities found in some of the most in-demand medications for heart failure and hypertension are a byproduct that emerge when certain active ingredients are mixed together.
If the drugs are made according to the ‘recipe’, there shouldn’t be a risk of this byproduct occurring.
The problem, experts say, is that the supplier in Linhai, China, Zhejiang Huahai Pharmaceutical Co, may not have been cleaning up after itself, or failing to invest in tools to screen for these contaminants.
The FDA insists that it would have been impossible for its inspectors to spot such an issue, since they can’t look for a specific byproduct, and they wouldn’t know which materials are inadvertently being mixed together.
The chemical was spotted in lots of valsartan provided by various top firms, including Novartis, after testing conducted by Valisure, an online pharmacy.
Valisure presented its findings to the FDA last week, forcing the agency into a new conundrum over how to get around the shortage.
Global authorities have been clamping down on sales of some blood pressure medicines for almost a year.
The drugs – valsartan and losartan, mainly made in China and India – were found to be tainted with two probable carcinogens – N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA).
European regulators first detected the contamination in spring 2018 and started taking action cutting off the offending supply. In summer 2018, the FDA followed suit.
In the fall, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis’ Sandoz recalled products containing the tainted ingredients.
Then, in January, the FDA confirmed that another cancer-causing toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), had been identified in 87 lots of losartan potassium pills made in India.
Controlling for NDEA, NDMA and NMBA is complicated.
They appear to be a byproduct of chemical interactions, though it’s not clear exactly which ones.
It’s unclear what the FDA will do in light of the new report.
It’s possible the FDA will return to an earlier strategy: telling Americans not to worry, and to keep taking their possibly contaminated drugs, insisting the levels of NDEA, NMDA, and NMBA were too low to be a concern.
That stance raised eyebrows among doctors and researchers.
Rosemary Gibson, author of ChinaRx: Exposing The Risks Of America’s Dependence on China For Medicine, told DailyMail.com in an interview: ‘Each Chinese-made tablet had more than 200 times acceptable limit, much more than other recalled products.’