The Food and Drug Administration on Tuesday approved a new generic version of valsartan to alleviate recent shortages of the blood pressure medication following a series of … Follow-up testing last fall showed some batches of valsartan also contained another probable carcinogen, N-Nitrosodiethylamine, or NDEA.More recent recalls revealed a third probable carcinogen – N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA – found in some blood pressure drugs.On Feb. 28, Camber Pharmaceuticals Inc. recalled 87 lots of losartan that contained small amounts of NMBA, the company said in a recall notice.
The U.S. Food and Drug Administration has approved a new generic of the blood pressure medication valsartan to help alleviate a recent shortage due to multiple safety recalls. Learn about side effects, warnings, dosage, and more. "About 2,300 batches were involved in the earlier recall across Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta, Sign-up to our daily newsletter for more articles like this + access to 5 extra articlesSee why nearly a quarter of a million subscribers begin their day with the Starting 5.Is Valsartan Safe?
"We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products," Gottlieb said.Gottlieb said the FDA will work with drug manufacturers to ensure other similar blood pressure medications, part of a class of drugs called angiotensin II receptor blockers, or ARBs, are available to consumers.
Valsartan is used to treat high blood pressure and heart failure. Not all products containing valsartan were recalled, however, the FDA said.The agency has launched an investigation into the levels of NDMA in the recalled medications, which will include an assessment of the potential harm to patients who have taken the drug.As medications that contain valsartan are often used to treat serious medical conditions, patients taking the recalled drugs should not stop until they have a replacement product, the FDA emphasized.Patients worried about their mediation should contact the pharmacy that dispensed it.Those who are taking the recalled medication should Valsartan by Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries Ltd, as well as Valsartan/Hydrochlorothiazide (HCTZ) by Solco Healthcare and Teva Pharmaceuticals Industries Ltd. were affected.Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement: "We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards. FDA Commissioner Scott Gottlieb said the recalls of valsartan that contained nitrosamine impurities "resulted in a shortage of these important medicines. Valsartan/hydrochlorothiazide oral tablet is available as a brand-name drug and a generic drug. On July 13, 2018, the U.S. Food and Drug Administration (FDA) issued a recall on pharmaceuticals containing the active ingredient valsartan. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Valsartan is in a class of medications called angiotensin II receptor antagonists. Brand name: Diovan HCT. The U.S. Food and Drug Administration has recalled a common drug used to treat heart conditions after it was found to contain a chemical linked to cancer. The FDA flagged concerns about valsartan, which is used to treat high blood pressure and heart failure, on July 13. A day later, Torrent Pharmaceuticals recalled 114 lots of losartan combination tablets that had trace amounts of NMBA.Consumers can check the FDA's website for a complete list of the recalled blood pressure drugs.Doctors advise affected consumers to continue taking their medication until a pharmacist replaces the drugs or provides another treatment.
Discontinuing a recalled drug could cause more immediate harm than staying on the medication.In the wake of its competitors' recalls, Alembic Pharmaceuticals last July more than tripled the price of 17 of its own formulations of valsartan.Those price hikes ranged from 329 percent to 469 percent, according to data from the health care analytics firm Elsevier.
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