Study Links Zantac Problems To Degradation Of Ranitidine

Study Links Zantac Problems To Degradation Of Ranitidine

Introduction

A study was published this month in the medical journal Organic Process Research & Development in which U.K. researchers working with Zantac manufacturer GlaxoSmithKline (GSK) suggested that the degradation of the active pharmaceutical ingredient ranitidine results in the formation of the cancer-causing chemical N-nitrosodimethylamine (NDMA).

Ranitidine hydrochloride is a drug sold under the name of Zantac, used to treat and prevent ulcers in the stomach and intestine. Earlier this year, the FDA requested manufacturers to discontinue all versions of Zantac from the market after finding that the cancer-causing chemical NDMA levels in the drug exceeded the set daily acceptable limit.

According to the latest study, the researchers conducted a root cause analysis and confirmed that the heat produced by the human body’s digestive processes aids in the transformation of the ranitidine molecule into the toxic chemical. The researchers further found that the impurities did not play any role in Zantac NDMA contamination.

The analysis was done using suitably isotopically labeled ranitidine hydrochloride, which revealed that the factors that influence the transformation were heat, humidity, and the crystal morphology of ranitidine hydrochloride with the material that exhibits a columnar habit showing a slower rate of degradation.

The manufacturer of the heartburn drug is facing more than 500 Zantac lawsuits, which were centralized under MDL No: 2924 in the Southern District of Florida for coordinated discovery and pretrial proceedings.

U.S. District Judge Robin L. Rosenberg, overseeing the Zantac litigation, is expected to establish a bellwether program that will set aside a small set of representative cases to be prepared for a series of early trials, unlikely to begin until at least 2022.

In October, Judge Rosenberg issued a pretrial order that outlined the information and reports that will be made available to the parties, which are extracted from census forms submitted as of September 30.

The court established the census in April to gather more information about all filed and unfiled claims. The census will enable the parties and the court to have a robust and timely understanding of the scope and size of the litigation and to facilitate early case management decisions.