USFDA recalls blood pressure drugs for potential cancer-causing component

The United States Food and Drug Administration (USFDA) has announced the voluntary recall of a batch of blood pressure drugs, after tests showed that it contained a potential cancer-causing component.

The recall involved one lot of Losartan Potassium Hydrochlorothiazide Tablets after tests showed that it contained a trace of an impurity called N-nitrosodiethylamine or NDMA, the USFDA said in a statement dated November 8.

"This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC),” the announcement read.

According to the USFDA, the affected lot is JB8912 which only involves 100 milligram/25 milligram tablets in 1,000-count plastic bottles, and released in the United States.

“Distributors and retailers that have the product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor,” it said.

“This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018,” it said.

Lozartan (100 mg) is sold in most drug stores in the country, ranging from P16 to P21 per tablet—depending on the manufacturer.

The 50 mg variety is priced at P10 to P27 per table, according to a sales clerk of a major Philippine drug store chain.

In a separate report earlier this November, CNN noted that several drugs that contain valsartan have been recalled in the US due to an “impurity” in the drug that poses a potential cancer risk. The drugs are used to treat high blood pressure and heart failure.

The impurity, NDMA, is classified as a probable human carcinogen, based on results from lab tests, it said.

Last July, the USFDA alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan.

“However, not all products containing valsartan are being recalled,” the agency said in a statement on July 13.

“The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” it said.

On Monday, GMA News Online has contacted officials of the Philippine Food and Drug Administration (FDA) to find out if a similar action has been, or will be, implemented in the country. But no response has been received as of this posting.

Text messages were also sent and calls made to Health Secretary Francisco Duque III, but no response has so far been received.

The drug was voluntarily recalled by Sandoz Inc., which clarified that it has not received any reports of adverse events related to the lot, according to the company's statement posted on the USFDA site.

In a separate statement on October 30 from ScieGen Pharmaceuticals Inc. and posted by the USFDA, the company said it “is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level.”

ScieGen noted the products were being recalled due to the presence of an impurity, N-nitrosodiethylamine contained in API Irbesartan, USP manufactured by Aurobindo Pharma Limited. —With Anna Felicia Bajo/Jon Viktor Cabuenas/VDS, GMA News