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The Food and Drug Administration alerts health care providers and patients that multiple versions of a common prescription drug used to treat cardiovascular disease are part of the voluntary recall due to the presence of A "chemical impurity" "unexpected" considered "probable". The US recall includes products containing the drug valsartan as an active ingredient supplied by a Chinese company and manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries and valsartan / hydrochlorothiazide sold by Solco and Teva
"We have carefully evaluated drugs containing valsartan sold in the United States, and we found that the valsartan sold by these specific companies does not meet our safety standards.These companies take immediate action to protect patients, "said the Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research, in Alert.
More than two dozen other countries have issued similar reminders, raising concerns about supply. A news report said that there were more than 2.5 million prescriptions for drugs involved in the recall distributed in Canada last year.
Ireland reported that its "precautionary recall" affected about 60,000 patients.
Scott Gottlieb said his drug shortage team was also working to meet the therapeutic needs of patients in the United States by providing them with adequate medications. "
" All medicines containing valsartan are not distributed. In the United States, valsartan is an active pharmaceutical ingredient (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. future products. "[19659002] It is thought that the impurity – n-nitrosodimethylamine – contaminated the active pharmaceutical ingredient during the manufacturing process.The chemical contained in tobacco smoke and some consumer products has been associated with liver and lung cancer in animals that have breathed for several weeks.
FDA webpage on valsartan It is advisable to check the product listings in any of the recalled products as "detection of an unexpected trace of impurity – NDMA."
The FDA advises concerned patients to check the name of the drug and the name of the company on the label of They indicate that patients should contact their health care professional and continue taking the recalled valsartan-containing medications until they have a replacement product.
Valsartan is described as a prescription drug. replaces An angiotensin II receptor antagonist used to treat hypertension, recent heart attacks and heart failure. It is said that it is available alone or in combination with other active substances.
Novartis is the company that originally developed the drug that is now said to be off-patent and used as a component of other generic drugs.
The European Medicines Agency began examining drugs containing the active substance valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company from Linhai, China, on July 5th.
The study was conducted at the request of the European Commission. Active pharmaceutical ingredient of valsartan may be as a result of changes in the way it is made.
The company provides the ingredient to manufacturers producing some of the valsartan drugs available in the European Union, and some initial reports were that US manufacturers were not affected.
NDMA is described as "a semi-volatile organic chemical that is formed in industrial and natural processes".
It is classified by the United States Environmental Protection Agency as a probable carcinogen to humans. It was formerly used in the production of rocket fuel, antioxidants and softeners for copolymers. On 5 July, UK regulatory authorities advised pharmacies to recall "all lots of drugs containing valsartan manufactured by Dexcel Pharma Ltd and Accord Healthcare as a precaution" following an "emergency".
Similar recalls have been issued elsewhere, including in Germany, Norway, Finland, Sweden, Hungary, Netherlands, Austria, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada Bosnia and Herzegovina, Bahrain and Malta.
The FDA has stated that it "will continue to investigate this issue and provide additional information as soon as it is available". The survey would include "studying the levels of NDMA in the recalled products" as well as "evaluating the possible effect on the patients who took them".
Patients and healthcare professionals are encouraged to report adverse reactions to products recalled to the FDA MedWatch Program.
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