USFDA lists alternatives to controversial heart burn drug Ranitidine

Our Bureau New Delhi | Updated on October 24, 2019

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Dr Reddy's shares fell by 1.05 per cent post the announcement, showed slight upward revision later in the day

The Hyderabad-based pharma multi-national company Dr Reddy’s Laboratories Ltd confirmed on Wednesday that it had decided to take off shelves the controversial anti-acidity drug Ranitidine in its United States (US) markets.

It has also already issued a world wide recall in September. However. a company spokesperson confirmed that Ranitidine is not sold by Dr Reddy's in the Indian markets.

The voluntary nationwide recall of all products of Ranitidine expiring between September 2019 to June 2021, was initiated on October 1, at the retail level for over-the-counter (OTC) products and at the consumer level for prescription products of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA, an alert issued by the USFDA stated. 

Shares of Dr Reddy's fell by 1.05 per cent on National Stock Exchange (NSE), as compared to previous day's closing on Thursday morning but as the day progressed have been showing upward revision.

The company was trading at Rs 2797.10 a piece on Thursday morning as compared to Wednesday's closing of Rs 2826.70. 

"This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of Ranitidine. To date, Dr Reddy’s has not received any reports of adverse events related to the recall of Dr Reddy’s Ranitidine products. The recall includes all quantities in the US that are within expiry," the US-FDA alert recall states. 

Also, French pharma major, Sanofi initiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150, Zantac 150 Cool Mint, and Zantac 75.

USFDA issued a public statement on September 13, 2019, alerting that some Ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing.

"Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the US products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues," the USFDA alert read. Active ingredients used in Sanofi’s Ranitidine products outside of the US and Canada are sourced from different suppliers. Sanofi has also issued a voluntary recall in Canada.

Published on October 24, 2019

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