FDA widens its recall of tainted blood pressure drugs

FDA widens its recall of tainted blood pressure drugs Do you know someone with high blood pressure? Be aware that the FDA has widened its re...

FDA widens its recall of tainted blood pressure drugs

Do you know someone with high blood pressure? Be aware that the FDA has widened its recall of tainted blood pressure medication containing the drug valsartan. A limited recall began in July but has since been expanded to this list of drugs.

The impurity in question, N-nitrosodimethylamine or NDMA, which was detected in several batches, is considered a possible carcinogen by the Environmental Protection Agency. It is an organic chemical that has been used to make liquid rocket fuel, and it can be unintentionally introduced through certain chemical reactions. It’s also a byproduct of the manufacturing of some pesticides and fish processing, according to CNN.

The latest recall includes medications made by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmac eutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).

“The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D., as the Dallas Morning News reported. “When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market. As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

The original recall has been li nked to a manufacturer in China, CNN reports. The substances were supplied by Zhejiang Huahai Pharmaceuticals, based in Linhai, in eastern China, which said it notified authorities as soon as it identified the impurity.

Patients who have been prescribed these drugs are advised to talk with their doctor or pharmacist about switching to a different company’s product. They should not quit the drugs until they are given a replacement, the FDA said.

Valsartan is an angiotensin II receptor blocker (ARB), and the FDA is investigating whether other types of ARBs are at risk for the presence of NDMA, the agency said. The investigation is ongoing and more brands could be added to the recall list.

“It’s not the drug valsartan that’s the problem. It’s a contaminant that was included in the manufacturing process that’s the problem. Patients shouldn’t lose faith in the drug itself,” Dr. Victoria Shin, a cardiologist with Torrance Memorial Medical Center in Tor rance, California, told Healthline.

Patients who have a bad reaction to a valsartan-containing drug should report it to the FDA’s MedWatch program by downloading this form online.

Source: Google News US Health | Netizen 24 United States