In the United States, withdrawals of parcels for cores are withdrawn: pharmacies already have shortages
Over the past six months, the Food and Drug Administration (FDA) has withdrawn dozens of batches of medicines prescribed for the treatment of high blood pressure. The reason was the fear that they might be contaminated with a carcinogenic chemical.
On Friday, the FDA said that currently the country lacks the often prescribed medicine Valsartan, but other drugs used in the treatment of high blood pressure may also become scarce due to ongoing reviews.
It has been discovered that some of the common Valsartan drugs sold in the United States are contaminated with the chemical NDMA, which is associated with cancer.
“Overall, the risk to individual patients remains very small, although this does not diminish the significance of this episode or our concerns,” said FDA Commissioner Dr. Scott Gottlieb and Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research.
The most recent review came on 18 in January, when Prinston Pharmaceuticals announced the voluntary recall of one batch of Irbesartan tablets and seven batches of Irbesartan HCTZ tablets, a common blood pressure medication.
Most of the identified lots were infected with NDEA or NDMA, N-nitrosodimethylamine, which the FDA has classified as “a probable human carcinogen”. These environmental pollutants are also found in water and food products, including meat, dairy products and vegetables,
Contaminated drugs were found in factories in China that produce Valsartan ingredients and send them to generic companies around the world.
In the summer of 2018, the FDA warned Chinese company Zhejiang Huahai Pharmaceutical Co. that some drugs containing Valsartan contain NDMA impurities and present a potential safety hazard. The FDA issued a warning letter to the company, which reported several production disruptions, including the control of impurities and cross-contamination from one production line to another.
"Companies knew they had a problem, but they didn't address it for six years," said Rosemary Gibson, a health care expert at the Hastings Center and author of "China Rx: Identifying the Risks of America's Dependency on China." “This is not an accident, this was a known serious problem.” This company was producing a dangerous product for people."
An FDA spokesperson told NBC News that the agency cannot predict how long reviews will last.
In 2016, about 14 million prescriptions for Valsartan or a drug that includes it were written out. Another 3,6 million appointments were written at Irbesartan this year.
According to representatives of pharmaceutical companies, side effects were not reported, but experts believe that foreign companies can minimize the risks to health.
"The primary manufacturer in question had more than 200 times the permissible level of NDMA per tablet," Gibson told NBC News. “This was much higher than the levels that the FDA found in other Valsartan products.”
The FDA has full list of drugs which can check.
The FDA offers to return the drugs from the list to the pharmacy or the doctor who issued them. Since not all batches of Lozartan, Valsartan or Irbesartan are involved in the recall, patients may switch to a version made by another company.
How serious is the risk of cancer
The FDA, which tests all drugs from foreign plants for use in the US, says the risk is very low. However, the FDA also notes that the levels of NDEA or NDMA, cancer-causing agents contained in samples are at unacceptable levels.
Because stopping heart medication is more at risk than infected drugs in the short term, doctors advise patients to continue taking blood pressure drugs until a replacement is prescribed, even if this drug is included in a review.
As the FDA is investigating the manufacturing process that has led to contamination, Gibson expects more drug reviews from blood pressure.
“This is just the tip of the iceberg,” she said.
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