Published: Fri, September 20, 2019
Markets | By Otis Pena

Novartis halts distribution of its Zantac versions amid probe into impurities

Novartis halts distribution of its Zantac versions amid probe into impurities

There are concerns that the generic version of the drug known as Zantac may cause cancer.

Drugmaker Novartis said it is halting distribution of all ranitidine medicines made by Sandoz, a measure it called "precautionary" after the acid-reducing medications were found to contain an impurity.

NDMA is classified as a probable human carcinogen.

Ranitidine is an over-the-counter and prescription histamine-2 blocker, which decreases the amount of stomach acid.

In an update on the Health Sciences Authority's (HSA) website on Monday (Sept 16), the authority said the medicines were found to contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA), in excess of the internationally acceptable level. It is the same chemical that was detected in generic blood pressure pills from China and other countries previous year that resulted in a recall of multiple versions of the drugs across 30 countries.

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Although no recall was ordered, the FDA said last week that patients using OTC ranitidine "could consider using other OTC medicines approved for their condition". Novartis stopped the distribution of its prescription version as a precaution.

Similarly, neither the U.S. Food and Drug Administration nor the European Medicines Agency had asked patients to stop taking the drug when the regulators said last week they were reviewing the safety of ranitidine. "In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines". "There are multiple drugs on the market that are approved for the same or similar uses as ranitidine". Other versions of Zantac have also been recalled in Europe and Canada as well.

"Our internal investigation is ongoing to determine further details", he added. The recalled drugs, which were manufactured in China, had higher levels of the NDMA chemical than USA health officials deemed acceptable.

The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients and said it will share the information when it is available.

The federal agency said NDMA is risky in large quantities, but the amount found in the heartburn drugs barely exceeds levels found in common foods.

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