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USFDA orders complete withdrawal of Ranitidine from the market

PT Jyothi Datta Mumbai | Updated on April 02, 2020 Published on April 02, 2020

Six months after the US Food and Drug Administration sounded a note of caution on Ranitidine, it has called for a complete withdrawal of the heart-burn drug from the market.

The move is expected to impact Indian drugmakers and suppliers of the active ingredient that go into the medicine, as regulators across the world, including the Drug Controller General of India, examine the USFDA’s latest action.

In its latest communication, the USFDA requested manufacturers to withdraw all prescription and over-the-counter versions of Ranitidine. The move followed ongoing investigation into the contaminant known as N-Nitrosodimethylamine (NDMA), a probable human carcinogen or cancer causing substance, the USFDA said.

Drug companies in India are making the medicine and exporting it, a regulatory expert told BusinessLine, adding that the USFDA had not explicitly “banned” the product.

The ranitidine market in India is pegged at  over ₹640 crore, according to market intelligence company AIOCD-AWACS. Key companies in the segment include Cadila Pharmaceuticals and JB Chemicals. There are also combination versions of the drug, for eg. domperidone with ranitidine or ondansetron with ranitidine. GlaxoSmithKline a larger producer of ranitidine exited the category after the USFDA’s alert last September. Ranitidine is commonly known as Zantac and Sanofi, which sells Zantac globally, does not sell it in India.

Explaining its decision announced on Wednesday, the USFDA said, the impurity in some ranitidine products increases over time and when stored at higher than room temperatures, it may result in consumer exposure to unacceptable levels of this impurity. Following the immediate market withdrawal request, “ranitidine products will not be available for new or existing prescriptions or OTC use in the US,” the agency said.

“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research.

September concerns

Concerns over contaminations started in September 2019, when the FDA became aware of independent laboratory testing that found NDMA in ranitidine. “Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans,”the US regulator said.

New FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, the USFDA said. NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers, the agency explained. “The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”

However, the FDA clarified that its testing had not found, till date, the presence of NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

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Published on April 02, 2020
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