FDA recalls some drugs for high blood pressure because of cancer risk | Health care

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SILVER SPRING, Md. – The United States Food and Drug Administration alerts health care professionals and patients of a voluntary recall of several drugs containing the active ingredient valsartan, used to treat bad cancer. # 39; arterial hypertension and heart failure

This recall is due to an impurity, N-nitrosodimethylamine (NDMA), present in the recalled products. However, not all products containing valsartan are recalled.

NDMA is clbadified as possibly carcinogenic to humans (a substance which can cause cancer) according to the results of laboratory tests. The presence of NDMA was unexpected and would be related to changes in the way the active substance was manufactured.

The FDA review is underway and included the study of NDMA levels in the recalled products, evaluating the possible effect on the patients who took them and what measures can be taken to reduce or eliminate the impurity of future batches produced by the company.

"The FDA is committed to maintaining our standard of excellence in safety and effectiveness." When we identify failures in the quality of drugs and manufacturing problems that may create risks for patients, we are able to determine the quality of drugs and the safety of their manufacture, "says Scott Gottlieb, MD, FDA.We are committed to taking prompt action to alert the public and help facilitate the removal of the products from the market and I am also working hard to ensure that the therapeutic needs of patients are met in the United States with an adequate supply of unaffected drugs. "

Information for Patients and Health Professionals [19659007] Valsartan is used in drug therapy patients taking medications containing valsartan recalled should continue to take their medications until they have a substitute.

  • To determine if a specific product has been recalled, patients should consult the name of the drug and the name of the company. of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that administered the medication to them.
  • If a patient is taking any of the medications listed below, 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.
  • The companies listed below recall all lots of unexpired products that contain the ingredient valsartan provided by a third party. All drugs containing valsartan distributed in the United States do not contain valsartan pharmaceutical active ingredient (API) provided by this specific company.
  • The supplier has stopped distributing its API valsartan and the FDA is working with the companies concerned to reduce or eliminate valsartan API impurity of future products

    • Recalled Products

    • Valsartan / Main Pharmaceuticals
    • Valsartan / Solco Healthcare
    • Valsartan / Teva Pharmaceuticals Industries Ltd.
    • Valsartan / Hydrochlorothiazide (HCTZ) / Solco Healthcare
    • ] Valsartan / Hydrochlorothiazide (HCTZ) / Teva Pharmaceuticals Industries Ltd.

    "We have carefully evaluated drugs containing valsartan sold in the United States, and we have found that valsartan sold by these specific companies does not meet our safety and that is why we asked these companies to take immediate action to protect patients, "said Janet Woodbad, MD, director of the FDA Cent for Drug Evaluation and Research.

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