Drugs

Emery Pharma Wants Zantac Recalled and Sales Suspended

Emery Pharma, an FDA-registered and inspected laboratory, says the agency should issue a regulation, revise industry guidance, and request a recall and suspension of sales of Zantac (ranitidine) and take other steps in response to an Emery study showing that the ranitidine molecule may not be heat stable and, under elevated temperatures, generates significant amounts of N-Nitrosodiumethylamine (NDMA). A 1/2 Emery citizen petition cites a 9/9/19 petition from a pharmacy reporting extremely high levels of NDMA irrespective of the manufacturer, manufacturing lot, dosage, and formulation of ranitidine.

The petition says that Emery found that while seemingly stable at room temperature, the ranitidine molecule is heat-labile and under elevated temperatures progressively accumulates NDMA. It says the finding was concerning because significantly elevated temperatures can occur within closed vehicles during transportation and during storage of the drug since there is no requirement that ranitidine be shipped in temperature-controlled conditions and stored under refrigeration.

While a potential solution to the issue would be to test each batch of ranitidine products for NDMA at the site of sale, rather than only at the production site, this could be impractical for many retailers, Emery says. The company says that ranitidine products should be shipped in temperature-controlled trucks and stored under refrigeration. It also says they should be labeled with clear warnings about storage conditions and could be required to carry a temperature indicator label that would inform consumers of excessive exposure to heat.

The petition calls on FDA to:

request a recall and suspend sales of all products containing ranitidine;
conduct examinations and inspections of ranitidine products, specifically stability assessment and the manufacturer submissions made for FDA approval;
provide information to the public about the high-temperature instability of ranitidine products;
issue additional guidance to the public on the safe disposal of ranitidine;
direct manufacturers of ranitidine products to conduct a thorough stability assessment of the compound for the formation of NDMA in both drug substance and product forms;
direct manufacturers and distributors to ship ranitidine products in temperature-controlled vehicles;
direct manufacturers to clearly label ranitidine products with a high-temperature warning; and
require that products containing ranitidine be moved behind the counter and dispensed by prescription only and ideally be tested for NDMA or otherwise assessed for heat exposure at the dispensing pharmacy and not just at the manufacturing site.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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