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"Overall, the risk for individual patients remains very small, although this does not reduce the significance of this episode or our concerns. FDA Commissioner Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Assessment and Research, said in a statement released Friday.
The most recent reminder occurred on January 1
Most of the identified lots are contaminated with traces of NDEA or NDMA, N-nitrosodimethylamine, which the FDA has classified as a "likely carcinogen for humans." Irbesartan These environmental pollutants are found in water and food, including meat, dairy products and vegetables.
The drug used for generic versions of the drug has the potential to generate the carcinogenic compound. In the summer of 2018, the FDA warned the Chinese company Zhejiang Huahai Pharmaceutical Co. that some generic drugs containing valsartan contain NDMA impurities and pose a potential safety hazard. The FDA issued a warning letter to the company citing several manufacturing violations, including impurities control and cross-contamination from one production line to another.
"Companies knew there was a problem, but they did not fix it for six. "said Rosemary Gibson, a health expert at the Hastings Center and author of" China Rx: Exposing the Risks of America's Relationship to China for Medicine. "" This is no accident, this is a serious problem.
An FDA spokeswoman told NBC News that the agency can not predict how long withdrawals will continue.
Nearly 60 million prescriptions are written for losartan in 2016 – the 9th most prescribed drug in the US – and nearly 14 million for valsartan or a drug that includes it. This year, another 3.6 million recipes for irbesartan have been written.
No adverse effects have been reported by drug company staff, but experts believe that foreign companies can minimize health risks. to an acceptable level of NDMA per tablet, "Gibson told NBC News. "This is far higher than the level the FDA has found in other valsartan products."
The FDA has an exhaustive list of medicines that can be searched for under a trademark.
The FDA cites changes made in the manufacturing process and a period in which uncleanness is unnoticed for reasons why tainted medicines fall into the hands of consumers. The FOT statement by Gottlieb and Woodcock also notes that "neither regulators nor industry have fully understood how NDMA or NDEA could be formed during this particular manufacturing process. distributor and manufacturer.
"You can find this on the pack or ask your pharmacist," she said. "And I will call them and ask," Is the product you gave me made with the active ingredients of the company in question? "
The FDA offers the drugs on the list to be returned to the pharmacy or the doctor who issued it. them. Since not all batches of losartan, valsartan or irbesartan are included in the seizure, patients may switch to a version made by a different company.
How serious is the risk of cancer?
The FDA, which checks all medicines from foreign factories that produce drugs for use in the US, says the risk is very low. However, the FDA also notes that levels of NDEA or NDMA, the cancer-causing agents contained in the samples, are at unacceptable levels. "FDA scientists believe that if 8,000 people received the highest daily dose of valsartan (320 mg) that contained NDMA for four years (the time when we think the affected products were in the US market) , there may be an extra cancer case out of the average cancer rate among those 8,000 Americans, "the FDA statement said. Since stopping heart treatment poses a greater risk to contaminated medicines in the short term, doctors advise patients to continue taking blood pressure medications until a replacement is prescribed even if the drug is included in the seizure. The FDA is investigating the production process that has led to pollution, Gibson expects more blood pressure drugs.
"It's just the tip of the iceberg," she said.