The FDA decision comes a week after 22 other countries imposed similar recalls.
A week after 22 countries recalled drugs used to treat high blood pressure and assist in the prevention of heart failure, the U.S. Food and Drug Administration (FDA) has followed suit. CNN reports that the recalled drugs contain forms of the ingredient valsartan that include the chemical N-nitrosodimethylamine (NDMA), an organic chemical that has been identified as a carcinogenic. The FDA has determined that valsartan produced by Major Pharmaceuticals as well as the valsartan produced and sold by Solco Healthcare and Teva Pharmaceuticals contains NDMA. Only the medications containing valsartan from these manufacturers are included in the recall.
Included in last week’s recalls were medications in Europe, Asia, and the UK. Novartis developed valsartan and announced that the formulations manufactured by Sandoz would be recalled because they “do not meet our high standards.” Included in that recall are valsartan/HCT film-coated tablets. Medications containing the ingredient as manufactured by Dexcel Pharma Ltd and Accord Healthcare have been recalled in the UK. Following last week’s recalls, Novartis indicated that medications sold in the United States do not contain the cancer-causing ingredient. In a statement about the recall, the FDA said that, “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
In studies performed on animals, the toxic ingredient has been shown to cause tumors in the liver, kidneys, and respiratory tract. Similar effects can occur in humans when NDMA is consumed at higher levels. It’s been found to cause liver damage and “is a probable human carcinogen.” The FDA is continuing their study of the chemical. Commissioner Dr. Scott Gottlieb commented about the organization’s responsibility in situations like this.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
Any patient currently taking a medication containing valsartan should speak with their physician. No drug treatment should be stopped without consulting with your physician. Because not all drugs containing valsartan are impacted by the recall, there may be a similar and safer alternative available.
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