Zantac’s Original Maker Halts Shipping on Carcinogen Concern

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(Bloomberg) -- GlaxoSmithKline Plc, the original branded maker of Zantac, halted global distribution of the popular stomach medicine, adding momentum to actions aimed at stopping access to drugs that are tainted with a potential human carcinogen.

Glaxo will also recall the drug in India, where it’s known as Zinetac, and Hong Kong. The recalled medicine is made with an active ingredient from two India-based suppliers, Dr. Reddy’s Laboratories Ltd. and Saraca Laboratories Ltd., Kristen Neese, a spokeswoman for Glaxo, said in an email Wednesday.

Dr. Reddy’s, one of India’s largest generic drugmakers, is cleared to sell its own finished versions of prescription and over-the-counter generic Zantac in the U.S. It hasn’t recalled any product, but last week it suspended all its shipments of the drug.

“Dr. Reddy’s is still evaluating potential impact of the issue,” Lori McCreary, a spokeswoman for the company, said in an email Wednesday. “We expect to provide an update in the coming days.”

A recall means drugs must come off of pharmacy shelves, while a distribution halt means the company is no longer supplying the drugs, though typically those already on shelves can be sold.

Not The First Time

Novartis AG’s Sandoz unit recalled its generic version of the drug, called ranitidine, on Tuesday, confirming it had found worrisome levels of the carcinogen called NDMA. Sandoz had already halted global distribution of generic Zantac.

Since last year, the U.S. Food and Drug administration has been overseeing a recall of a type of generic blood-pressure pills that originated in China and India and were also contaminated with NDMA.

Glaxo’s shares fell less than 1% to 1,676.60 pence in London trading. Novartis barely budged at 85.05 Swiss francs in Zurich.

Glaxo first won FDA approval for Zantac in 1983, though later discontinued it, according to the agency’s website. About two dozen generic drugmakers have since gained permission to sell their own versions of Zantac. Glaxo doesn’t supply or manufacture ranitidine products in the U.S. or Canada, said Kathleen Quinn, a spokeswoman for the company. Glaxo does supply ranitidine products in multiple markets in Europe that are made at sites in Italy and Spain, and via third-party manufacturers in Germany, according to Quinn.

French drug giant Sanofi won approval beginning in 1995 to sell the branded Zantac without a prescription. Sanofi has halted distribution in Canada, where health officials required such a move, but doesn’t have any plans to stop distributing Zantac elsewhere, Ashleigh Koss, a spokeswoman for the company, said in an email.

FDA’s Own Tests

The FDA put out a statement Tuesday evening about Sandoz’s recall but Jeremy Kahn, an agency spokesman, declined to share the levels of carcinogen detected in the products.

“Our testing of ranitidine products is ongoing and we will take appropriate measures based on the results of the investigation,” Kahn said in an email.

The FDA investigation came after online pharmacy Valisure, which tests all medications that it distributes to customers, detected NDMA in brand-name and generic versions of Zantac. Some versions of the drug are available only with a prescription while others can be bought over the counter.

In the meantime, the Italian Drug Agency said last week it was ordering a recall of all versions of Zantac made with active ingredient from Saraca, the Indian manufacturer. Italian regulators also banned the use of some types of Zantac produced by other pharmaceutical companies pending analysis of the drugs.

Germany’s drug regulator indicated last week that there were wider recalls of ranitidine made with active ingredient from Saraca in Europe.

©2019 Bloomberg L.P.

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