FDA withdraws certain drugs that could pose a health risk

The United States Food and Drug Administration. alert health care professionals and patients about the convenience of voluntary withdrawal of various pharmaceuticals containing the active ingredient Valsartan used to treat hypertension and heart failure

The shrinkage is due to an impurity, N-nitrosodimethylamine (NDMA) that was found in the recalled products and is clbadified as probable carcinogen to humans (that is, a substance that could cause cancer.)

The presence of NDMA was unexpected and would be related to changes in treatment. He made the active substance. However, not all products containing Valsartan are recalled.

The review is underway and has included the study of NDMA levels in the recalled products. We have proceeded to the evaluation of the possible effect in patients who have already taken the affected drugs and measures that can be taken to reduce or eliminate the impurity of future batches produced by the patient. ;business.

FDA Commissioner Scott Gottlieb stated that the Agency is committed to maintaining its gold standard for "Safety and Efficiency" which would include "efforts to to ensure the quality of medicines and the safe way they are made. "

He added: "When we identify deficiencies in the quality of drugs and manufacturing problems that may create risks for patients, we are committed to taking prompt action to alert the public and help facilitate the safety of patients. Although we are looking to eliminate some drugs today, our shortage drug team is also working The therapeutic conditions of patients are met in the United States with an adequate supply of unaffected drugs. "[19659006] Whereas Valsartan is used in medications that treat serious medical conditions, patients who take medications that have been removed should continue to take it 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 on the label of their vial. Recipe

If the information is not in the bottle, then patients should contact the pharmacy that administered the medicine.

If a patient is taking any of the medications listed below, he should follow the withdrawal instructions provided by the specific company, which also appears on the FDA website.

If a drug is on the list, patients should also contact their health professional (the pharmacist who dispensed the drug or the doctor who prescribed it) to decide how to proceed, which may include a other valsartan product not affected by this recall or alternative treatment.

The companies listed below remove all lots of unexpired products containing the ingredient valsartan provided by a third party.

All drugs containing valsartan distributed in the United States do not contain the active pharmaceutical ingredient valsartan (API) provided by this specific company.

The supplier has stopped distributing its valsartan API and the FDA is working with the companies concerned to reduce or eliminate the API Valsartan impurity of future products.

Janet Woodbad (Director of the FDA Drug Evaluation and Research Center) stated that drugs containing valsartan sold in the United States have been carefully evaluated and that valsartan sold by these specific companies is not did not meet "safety standards". He added: "That's why we asked these companies to take immediate action to protect patients."

The media point out Monday that the FDA will continue to investigate the problem and provide additional information as soon as it is available.

The FDA asks patients and health professionals to report any adverse reactions to the FDA's MedWatch program.

The FDA, an agency of the US Department of Health and Human Services. UU., Protects public health and researches the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices.

He is also responsible for the safety of the food supply, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of our nation's tobacco products.