DOH says FDA Philippines to recall blood pressure drugs

The Department of Health said Monday the Food and Drug Administration Philippines intends to recall blood pressure maintenance drugs in the market if found to be part of the batches that were alerted by FDA’s US counterpart for voluntary recall.

FDA Philippines has vowed to recall any medicine which will be found contaminated by any harmful component, a department official told GMA News Online.

“All reported recalls are being checked by our FDA,” Health Undersecretary Rolando Domingo said.

Domingo issued the statement in light of voluntary recalls put in place by pharmaceutical companies in the US after the USFDA red-flagged specific batches of blood pressure drugs due to the presence of an impurity identified as N-nitrosodiethylamine—a potential human carcinogen.

Losartan and Irbesartan are part of the voluntary recalls issued by their respective manufacturers

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.

“The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020,” Sandoz Inc. said in a statement on Nov. 8, 2018.

The Sandoz statement was posted by the USFDA on its website “as a public service.”

Losartan (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 dosage is priced at P10 to P27 per table, according to a sales clerk of a major Philippine drug store chain.

ScieGen Pharmaceuticals Inc. also issued a voluntary recalled on Irbesartan tablets (75 mg, 150 mg, and 300 mg) from the US market late last October due to the presence of an impurity identified as N-nitrosodiethylamine.

“If you are taking Irbesartan, please examine your tablets and look for the specific markings to determine if you’re product is affected by this recall. Products can be best identified by patients as being white, oval shaped tablets debossed with SG 160; SG 161; or SG 162,” SieGen said.

Irbesartan is also a popular blood pressure drug in the Philippines.

“All reported recalls are being checked by our FDA,” DOH’s Domingo said.

Last July, the USFDA also 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.—VDS, GMA News