FDA expands recall of blood pressure drug valsartan
The US Food and Drug Administration expanded the list of drugs being recalled that contain valsartan. The drug is used as a component in a set of drugs used to treat heart failure and blood pressure.
New to the list are some valsartan products manufactured by Hetero Labs Ltd. in India, which are labeled as Camber Pharmaceuticals Inc. Test results show that some of the products may be tainted.
The FDA announced a valsartan recall in July after lab tests revealed that some drugs could have been tainted with a substance linked to higher risk of cancer. The drug had been recalled in 22 other countries. The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide. Not all of the drugs containing valsartan were affected.
N-nitrosodimethylamine or NDMA, the impurity the lab tests found, is considered a possible carcinogen by the US 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 a byproduct of the manufacturing of some pesticides and fish processing.
The medicines that are now a part of this expanded list in the recall are tablets sold by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical 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 also published a list of valsartan products that are not currently recalled. Only the drugs suspected of being tainted with NDMA are on the recall list. If you are taking a valsartan drug, look for the company name on your prescription bottle. If the information isn’t on the label, you can call your pharmacy for those details.
The recalled medicine is linked to a manufacturer in China. 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.
“We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time … all the drug materials for the Chinese market were recalled by July 23,” the company said in a statement to the Shanghai stock exchange last month.
The FDA said on its website that it’s working with drug manufacturers “to ensure future valsartan active pharmaceutical ingredients are not at risk.”
If you are worried that your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.
If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.
To get a sense of what taking a tainted drug could mean, FDA scientists estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) from the recalled batches every day for four years, there may be one additional case of cancer.
“The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful,” Dr. Mary Ann Bauman, a representative for the American Heart Association, said in July. “You don’t want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first.”