FDA Expands Recall: Updates
A medicine manufacturer has issued a worldwide recall of a commonly-used medication. Government investigators have found "traces of a dangerous carcinogen" in the medication on Sunday, according to a CNN report on Monday.
The Chinese medicine manufacturer has been through this before. This is its second major medical issue in less than a month. The first one involved hundreds of thousands of children's vaccines. These vaccines were found to be "faulty," and has put many infants at risk.
The medication recall began in July, and the product was recalled in 22 countries across North America and Europe after investigators discovered a contaminated batch containing N-nitrosodimethylamine (NDMA), which is an organic chemical that is linked to potent carcinogens.
Since then, the recall has been expanded twice, according to CBS News. The amount of NDMA found in these medications has exceeded the acceptable levels.
"The FDA estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of those 8,000 people," according to CBS.
According to animal studies and the U.S. Environmental Protection Agency, NDMA has been shown to cause kidney, liver, and respiratory track tumors. In just the U.S. alone, all Valsartan products were a market worth of $20 million in sales in 2017.
The heart medication in question is called Valsartan. This drug is used to help prevent heart failure, and it is used to treat high blood pressure. A list of the recalled medications can be found on the FDA's website. Only products that have been contaminated with NDMA are being recalled, not all Valsartan tablets are being removed.
"It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications," according to the FDA.
The supplier of Valsartan is Zhejiang Huahai Pharmaceuticals (ZHP). They are based in Linhai which is located in eastern China. ZHP said that they notified health officials as soon as they discovered the defect.
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