Federal agencies say they have identified the cause of the carcinogenic impurities that have contaminated millions of bottles of commonly used generic blood pressure and heart failure medicines by drug manufacturers over the past seven months.
The carcinogens are a chemical by-product of the process used in the synthesis of the active substance in the medicinal products, which include valsartan, losartan and irbesartan. According to the Food and Drug Administration, people who take these medicines may have been exposed to contaminants for at least four years after companies changed their mode of production.
An FDA statement announced on Friday that the pollutants, called N-nitrosodimethylamine and N-nitrosodiethylamine, are formed when "certain chemicals and reaction conditions are present. , , and may also result from the reuse of materials such as solvents. "The agency said these by-products have not been detected during routine inspections as the process depends on scientists knowing which chemical intruders are randomly generated during the process. They said regulators and companies have not existed until recently.
But David Light, chief executive of Valisure, an online pharmacy that chemically validates medicines before they are shipped to consumers, said it was possible that companies would not clean up drugs as a cost-saving measure. It would not have been unexpected, he said, that the synthetic process would produce impurities.
"In chemistry, it's pretty easy to throw some chemicals together and get a reaction," said Light. "What's hard to do is clean it up and just get the product you want. , , , The manufacturers know or should have known about the pollution. There are common precision tools to analyze these pollutants, and there are standard methods to eliminate them. "
It is not yet clear how many patients may have been exposed to carcinogens, but authorities have estimated that 1 to 2 million people could have taken the drugs containing the impurities.
"We are taking important steps to understand how these impurities have come about, to reduce the risk to patients and to learn what steps need to be taken to avoid this happening again in the future." Commissioner Scott Gottlieb and Drug Evaluation and Research Director Janet Woodcock said in a statement. "While the overall exposure of these contaminants was low in most patients, we are deeply concerned that patients were exposed to this contaminant at all and the presence of nitrosamines remained undetected for a period of time."
The Agency has done this The risks to public health of the contamination have been downplayed and it has been pointed out that the carcinogens are also found in smoked and grilled meats. If 8,000 people took the highest dose of a drug, valsartan, for four years, there could be another cancer case. However, the official limit, which is considered "safe" for human consumption, is much lower – and would be in the course of a lifetime cause less than one additional case of cancer in 100,000 people.
The study of unfolding illuminates the dark corners of a complex. international supply chain for pharmaceuticals – and especially the difficulties that can arise when generic generic safety problems arise for multiple drug manufacturers and repackaging companies Use ingredients from a factory or a small handful of them.
The problems were first noted in medicines derived from Zhejiang Huahai Pharmaceutical Co., a drug manufacturer in China, but also in drugs made from Hetero Labs drugs in India. Generic drug companies include Mylan Pharmaceuticals, Teva Pharmaceuticals, Sandoz, Prinston Pharmaceuticals, ScieGen, and Torrent Pharmaceuticals. Some of these companies also sell the drugs under different brands. For example, Prinston recalled batches of medicines labeled with Solco Healthcare, and Teva recalled batches manufactured by Actavis and Major Pharmaceuticals.
Valsartan has been in short supply since August, and the agency warned in its statement that "other types of drug-related products could run out soon," without giving any specifics. "The agency is calling on patients to take their medication until it is over a pharmacist or doctor offers another option as they need to balance the risk of runaway blood pressure for a small increased risk of cancer.
An FDA spokeswoman said the investigation is continuing and it's impossible to predict how many more recalls it will She said pharmaceutical companies would continue to test their products and withdraw pills containing impurities beyond an FDA-mandated transition period to ensure that patients can continue to access the drugs in the short-term.
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