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A popular drug used in medications to treat high blood pressure and heart failure was recalled on a potentially carcinogenic ingredient, according to the Food and Drug Administration (FDA).
The FDA recently announced a voluntary recall of the active ingredient valsartan – a drug used in several generic drugs to treat high blood pressure and heart failure.
During tests, the drug was found to contain an impurity called N-nitrosodimethylamine (NDMA), which is clbadified as a carcinogen, said the FFA, adding that the discovery of NDMA was "unexpected". The FDA has said that it believes that it is "related to changes in the way the active substance has been manufactured."
NDMA is also found in liquid fuels, additives for lubricants and softeners, among other processes, according to the website of the Environmental Protection Agency
. The FDA has stated that she was going to study the levels of NDMA in the recalled products, including "the possible effect on the patients who took them and what steps can be taken to reduce or eliminate the impurity of future batches produced by the company. "
The following products are listed in the recall, according to the FDA:
- Valsartan from Major Pharmaceuticals
- Valsartan from Solco Healthcare
- Valsartan from Teva Pharmaceuticals Industries Ltd.
- ] Valsartan / Hydrochlorothiazide (HCTZ) from Solco Healthcare
- Valsartan / Hydrochlorothiazide (HCTZ) from Teva Pharmaceuticals Industries Ltd.
In a statement, the FDA said it found that the drug "sold by these specific companies does not meet our"
"That's why we asked these companies to take immediate action to protect patients, "said Janet Woodbad, director of the FDA's Center for Drug Evaluation and Research, in her release [19]. 659,015]. encourages patients and healthcare professionals to report adverse reactions to the FDA's MedWatch program.
The FDA recommends the following to patients and health care professionals:
- Patients Taking the Medication Drugs containing valsartan should be stored until they are replaced.
- To determine if a specific product has been recalled, patients should consult the name of the drug and the name of the company on the label. If information is not available, patients should contact the pharmacy.
- If a patient is taking one of the recalled medications, he must follow the recall instructions provided by the company in question. This information will be posted on the FDA website
- Patients should also contact their healthcare professional (the pharmacist who prescribed the drug or the pharmacist who prescribed the medication) if their medication is included in this recall . include another valsartan product not affected by this recall or other treatment option.
For more information on the recall, visit the FDA's recall website at FDA.gov.
Spencer Kent can be reached at skent @ njadvancemedia .com. Follow him on Twitter @SpencerMKent . Find the Find NJ.com on Facebook.
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