EMA Re-examines Zantac; Confirms Suspension In The EU

EMA Re-examines Zantac; Confirms Suspension In The EU

Introduction

On September 18, the European Medicines Agency (EMA) issued a press release confirming its prior recommendations dated April 3, 2020, to suspend ranitidine throughout the European Union due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA). The suspension confirmation is the result of a request made by one of the drug makers selling the generic Zantac to re-examine its decision over the ban.

The recent re-examination of Zantac safety was conducted by EMA’s human medicines committee (CHMP). The committee announced the conditions over lifting the suspension, along with the requirements for companies to provide more data on the possible formation of NDMA from ranitidine inside the body. The CHMP revised the conditions for lifting the suspension for those ranitidine medicines that are given by injection or infusion as a single dose, stating that the NDMA formation in the body is expected to be very low when administered by the stated method.

The Food and Drug Administration (FDA) had issued a similar recall of the heartburn drug from the U.S. market on April 1, 2020, after finding that independent tests showed the levels of NDMA could increase over time and with exposure to high temperatures in ranitidine medications.

The public was not aware of the high levels of NDMA produced by Zantac until the testing was done by an independent online pharmacy, Valisure, in September 2019. The pharmacy claimed that each pill might result in a level of exposure higher than the limit set by the FDA regarding the intake of NDMA and filed a citizen’s petition with the FDA, calling for the recall.

Last month, the FDA also issued guidance recommending the manufacturers of active pharmaceutical ingredients and drug products to implement steps to avoid drug contamination with cancer-causing chemical by-products, such as NDMA and other nitrosamine impurities.

Several lawsuits have been filed in the U.S., after the recall, by former users of Zantac who were diagnosed with bladder cancer, kidney cancer, colorectal cancer, stomach cancer, and other forms of cancer allegedly caused due to years of exposure to NDMA in Zantac.