FDA expands drug recall

FDA expands drug recall

Some Indian-supplied batches of a heart medicine may pose cancer risk

The Food and Drug Administration (FDA) has expanded its recall of valsartan, a medicine used to control blood pressure and help prevent heart failure, after some ingredients were found to contain an impurity.

In the latest alert, the FDA is recalling the batches of valsartan that use pharmaceutical ingredients supplied by India's Hetero Labs Limited.

The ingredients contain high levels of N-nitrosodimethylamine (NDMA), a substance that poses a potential cancer risk.

Surachoke Tangwiwat, the FDA deputy secretary-general, said the recall affects three pharmaceutical companies -- two of them being importers and distributors of valsartan supplied by the Indian-based manufacturer, and the other a licensed manufacturer of the drug using ingredients from the Indian firm.

Valsartan is off-patent and is used as a component in other generic medicines.

Two formulas that are being withdrawn from the shelves are DOFORGE-160 and VALSAN-160.

The importers of the drugs are also required to submit the details of the imports and the sales of valsartan with the impurity since 2015 to the FDA by Aug 31 while the local manufacturer is required to recall the drug within 15 days.

"The FDA has ordered the importers to suspend sales of valsartan that use the ingredients from Hetero Labs Limited and to submit the details of the drug imported since 2015. The licensed manufacturer has been instructed to end the production and sales," he said.

Last month the FDA recalled five formulas of valsartan that used pharmaceutical ingredients supplied by Zhejiang Huahai Pharmaceuticals. The materials from the China-based manufacturer were found to contain NDMA.

The five formulas that were already withdrawn are Valatan 80, Valatan 160, Valsarin 80, Valsarin 160 and Vasarin 320.

The expanded recall is unlikely to affect patient care due to the availability of other valsartan products.

According to Dr Surachoke, following the extended recall, a total of 36 formulas of valsartan are still available for consumption. Thirty-one of them are imported and the rest are locally produced.

"The FDA will see to it the recalled medicine is properly destroyed. A rapid alert has been sent to relevant agencies nationwide," he said.

Dr Surachoke is urging users of valsartan to check their medicine and return them to hospitals or clinics that prescribed the drug if they are DOFORGE-160 or VALSAN-160 and ask their doctors for new prescriptions.

Two weeks ago, the FDA recalled serratiopeptidase after doubts over its anti-inflammatory efficacy were raised in Japan after more than 40 years on the market.

The drug, also known as serrapeptase, or Dasen in Japan, has been ordered removed from the market within 15 days and its production formula has also been withdrawn from registration in Thailand, according to the FDA.


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