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By Shamard Charles, MD
Over the past six months, over the past six months, the high and low blood pressure has been recalled by the Food and Drug Administration They may be contaminated with a cancer-causing chemical. On Friday, the FDA said it is currently in the process of being used in a short-term delivery procedure.
Several generic valsartan products sold in the US
"Overall, the risk of individual patients remains very small, although this does not diminish the significance of this episode or our concerns," FDA Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, said in a statement released on Friday.
Jan. 1
NDEA or NDMA, N-nitrosodimethylamine, which the FDA has classified as a "probable human carcinogen. "
The contaminated drugs were traced to factories in China that make valsartan ingredients and ship them to generic drug companies throughout the world
Woodcock told NBC News.
In the.
The process to make the generic version of the drug has the potential to generate the carcinogenic compound Zhejiang Huahai Pharmaceutical Co. Zhejiang Huahai Pharmaceutical Co., Ltd. is a generic valsartan-containing medicines NDMA impurity and posed a potential safety concern.
"The companies knew it had a problem, but did not fix it over the course of six "It's not a fluke, it's a known serious problem," said Rosemary Gibson, a health care expert at the Hastings Center and author of "China Rx: Exposing the Risks of America's Dependence on China for Medicine."
An FDA spokeswoman told NBC News that the agency could not predict how long the recalls would continue.
Nearly 60 million prescriptions were written for losartan in 2016 – the most prescribed drug in the US – and nearly 14 million for valsartan or a drug that includes it.
"The main manufacturer in question has had more than 200." times the acceptable level of NDMA via tablet, "Gibson told NBC News.
The FDA has a comprehensive list of medicines under recall which can be read by brand name.
The FDA has made changes to the manufacturing process process and a period where the impurity was undetected as to reasons why the tainted drugs got into the hands of consumers. The FDA statement from Gottlieb and Woodcock also noted that "NDMA or NDEA could not form during this particular manufacturing process."
Gibson admitted patients having prescriptions for the distributor and manufacturer.
"You can find that on the package or you can ask your pharmacist," she said.
The FDA suggests that the pharmaceuticals or doctor-to-patient list should be returned to the FDA them.
How serious is the risk of cancer?
The FDA, which inspects all drug products, reports that it is not safe to use any other drugs from foreign factories that make drugs in the US, says the risk is very low. However, the FDA notes that the levels of NDEA or NDMA are "the cancerous residuals contained in the samples are at unacceptable levels."
"FDA scientists estimate that if 8,000 people took the highest daily valsartan dose (320 mg) that contained NDMA, for four years, there may be an additional case of cancer among the 8,000 Americans, "the FDA said in the Friday statement.
Because of the fact that the drug is included in a short term,
As
"This is just the tip of the iceberg," she said.
