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All ranitidine should be discarded, says US drug agency

BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m1390 (Published 06 April 2020) Cite this as: BMJ 2020;369:m1390
  1. Owen Dyer
  1. Montreal

The heartburn and stomach ulcer drug Zantac (ranitidine) and its generic equivalent should be removed from pharmacy shelves and should be discarded if found at home, the US Food and Drug Administration has said.

The agency cited new findings from its analysis of stockpiled ranitidine, which showed that levels of the probable carcinogen N-nitrosodimethylamine (NDMA) increased over time in the drug during storage.1

New FDA testing, the agency said, had “confirmed that NDMA levels increase in ranitidine even under normal storage conditions, and 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.”

Levels could rise above the acceptable daily intake limit, the FDA’s announcement warned. “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,” it said.

“I can’t recall anything exactly like this happening before,” said Janet Woodcock, a senior FDA official, at a press briefing.

String of recalls

The FDA first warned of NDMA in ranitidine last September after testing a new product. The agency said that the levels found were usually not dangerous—little higher than the level in many foods. But there followed a string of recalls from various manufacturers of batches that tested higher.

Meanwhile, the FDA and its counterparts the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency were investigating claims that the NDMA level could rise during storage. Sales plummeted late last year as the FDA began counselling doctors to consider alternative drugs.

In the UK all ranitidine products were discontinued in November, and doctors were told not to start patients on them.2 In December injectable ranitidine became available again in the UK, but its stockpiling was discouraged.3 The oral product is still unavailable in the UK while investigations continue. The FDA is asking for both oral and injectable products to be discarded and their sale discontinued.

The European Medicines Agency said last month that it was also investigating findings of NDMA in some batches of metformin, a standard diabetes treatment considered a critical medicine.4

References

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