The U.S. Food and Drug Administration has issued a worldwide recall of Valsartan, a high blood pressure medication. This drug, which also treats heart failure, is fear to have cancer-causing chemicals known as N-nitrosodimethylamine (NDMA).
FDA revealed that some drug prescriptions containing active ingredient valsartan are being recalled because of the possible contamination of carcinogen NDMA. This chemical is said to be dangerous to the liver and other organs.
"The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured," the FDA said, per Fox 46. FDA's Center for Drug Evaluation and Research director Janet Woodcock M.D. revealed that they have thoroughly checked the valsartan-containing medications sold in the United States.
From here, they found out that the valsartan sold by some companies didn't meet the FDA's safety standards. "This is why we've asked these companies to take immediate action to protect patients," she said.
Patients who use valsartan-containing medications should check the drug and company names on the prescription bottle's label to see if their medication is affected by this recall. However, if the medicine doesn't come with any information, they could call the pharmacy that sold the drug.
Also, KXAN noted that patients should also call their physicians who prescribed their medication if their medicine is affected by the recall. If it is, then they should talk about an alternative to this treatment to continue their medication.
According to NBC Chicago, FDA continuously works with drug companies to assure that their future valsartan-containing medicines don't contain NDMA. The federal agency, too, told these manufacturers to carefully assess its API manufacturing procedures and changes to see "unsafe impurities" quickly.
The FDA also asks patients and health care workers to report any of the medicine's adverse reactions to the agency's MedWatch program.
The FDA said in a news statement that it is now reviewing and investigating the amount of NDMA in the recalled drugs. It is, too, examining the possible effects of the said medication on the patients who already took it. It is also studying the possible measures to lessen or completely remove impurities from the future valsartan-containing medicines produced by drug companies.
The Brodie Lane Pharmacy owner and pharmacist Aaron Williams explained that the presence of NDMA found in valsartan-containing medicines is "thought to be related to changes in the way the active substance was manufactured."
The FDA has updated its list of products that are part of the recall and the list of the unaffected medicines.
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