October 26, 2020

Volume X, Number 300

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October 23, 2020

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FDA Zantac Recall: Too Little, Too Late

In the face of mounting nationwide lawsuits and continuing alarming testing data, the United States Food and Drug Administration (FDA) has finally announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. As a result of this immediate market withdrawal request, ranitidine products (commonly known by the brand name Zantac) will not be available for new or existing prescriptions or OTC use in the U.S.

The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, and seek other drugs approved for the same or similar uses as ranitidine that do not carry the same cancer risks.

We have previously discussed early independent laboratory testing that showed high levels of the harmful compound N-Nitrosodimethylamine (NDMA) in ranitidine medications. Initially, we reported that the FDA had a relatively tepid response to these very troubling findings, suggesting that some of the high NDMA levels may have merely been produced by the testing methods employed (basically saying that the samples were subject to high temperatures during testing that may have caused the ranitidine to break down into NDMA).

With this latest action, the FDA now asserts that:

New FDA testing and evaluation prompted by information from third-party laboratories 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. 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.

The FDA also stated that “sustained higher levels of exposure may increase the risk of cancer in humans.” This forms one of the many bases of the Zantac lawsuits that continue to be filed across the nation. Previously, we discussed the best way to determine whether you may have a claim encompassed within those lawsuits.

COPYRIGHT © 2020, STARK & STARKNational Law Review, Volume X, Number 101
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About this Author

Martin P. Schrama, Stark Law, Intellectual Property and Litigation Law Attorney
Shareholder

Martin P. Schrama is a Shareholder in Stark & Stark's Commercial Litigation, Mass Tort, Intellectual Property and Green Litigation Groups. Mr. Schrama has extensive experience litigating on both the trial and appellate levels of the federal and state courts of New Jersey and New York, as well as numerous other jurisdictions throughout the nation in a pro hac vice capacity. This experience also extends to regular practice before AAA, JAMS and various other alternate dispute resolution fora.

The primary focus of Mr. Schrama’s practice is...

609-895-7334
Stefanie Colella Walsh, Pharmaceutical Litigation Attorney, Stark Law Firm
Shareholder

Stefanie Colella-Walsh is a Shareholder and member of Stark & Stark’s Litigation, Insurance Coverage & Liability, Intellectual Property and Mass Torts Groups where she concentrates her practice in complex litigation with a focus in mass tort and pharmaceutical litigation. She also handles litigation related to nursing home negligence and abuse claims, elder abuse, and assisted living facility litigation.

Recently, Ms. Colella-Walsh was a member of the national trial team involved the first trial in the country of a TVT-Secur transvaginal mesh device case against Ethicon/Johnson and Johnson. 

609-219-7416
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