Sandoz-Losartan medicines sold in PHL ‘are safe’

The blood pressure maintenance drug Losartan sold in the country is safe, a corporate  executive of Sandoz in the Philippines said Tuesday.

The Sandoz Losartan that is sold in the Philippine market is different from the Losartan 100 mg and 25 mg tablets that were flagged for voluntary recall by the United States Food and Drug Administration, Christine Fajardo, country public affairs and corporate responsibility head of Sandoz Philippines Corporation, told GMA News Online.

The products were eventually recalled by Sandoz Inc. in the US market early this November.

The USFDA’s alert for voluntary recall was prompted by the presence of an impurity identified as N-nitrosodiethylamine—a potential human carcinogen.

Specifically, the US FDA identified the red-flagged medicine as Sandoz-Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020.

“Those referred to by the USFDA are sold in the United States and Taiwan. These are not sold in the Philippines. Sandoz-Losartan’s coated tablets sold in the Philippines are safe,” Fajardo said.

“We are issuing this clarification to prevent unnecessary discontinuation of regular intake of medicines which is crucial to maintaining the blood pressure of hypertensive patients. Rest assured that Sandoz’s products meet the highest quality and safety standards,” Fajardo said.

Undersecretary Rolando Domingo of the Department of Health earlier told GMA News Online that the Health department will make sure that contaminated medicines would be pulled out of the market.

“All reported recalls are being checked by our FDA. If such red-flagged medicines entered our market, we will recall them,” Domingo said.

In a separate text message, the DOH official said the FDA Philippines cannot yet officially confirm if the supply of Losartan in the country is safe.

"FDA asked for the distribution list of Sandoz to confirm this," Domingo said.

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 at a major Philippine drug store chain. —with Ted Cordero/VDS/NB, GMA News