Zantac settlements

Ranitidine, a heartburn medicine sold under the brand name Zantac among others, was pulled from shelves in 2019,[1] following disclosure [2] of potential carcinogenic effects,[3][4] which its manufacturers were accused of "engaging in a decades-long scheme to conceal."[5]

By 2020, the US Food and Drug Administration was telling consumers to discard whatever Zantac they still had.[6]

## Contents

* 1 Overview
* 2 Oversight
* 2.1 Infants and children
* 3 Lawsuits
* 4 Zantac pill switching settlements
* 5 See also
* 6 References

## Overview

Zantac was first marketed in 1981,[7] and it was described in 1989 as "one of the most expensive drugs on the market",[8] and "the world's biggest-selling prescription drug".[9] Addiction to taking it ("a habit") was how some of its users described Zantac.[10] The focus of Glaxo, its manufacturer, was to gain market share "from Zantac competitors like Tagamet."[9] Cimetidine, sold under the brand name Tagamet among others, was listed in 2020 as an alternative to Zantac.[11]

The company also introduced a half-strength[12] Line Extension named Zantac 75.[13]The Los Angeles Times headlined "Public Faces Overdose of Similar Drug Names."[14]

The market for Zantac[15] and its competitors was described in 2005 as 13.5 billion US dollars.[16]

The product's problem was described by The New York Times as being "that a potential cancer-causing contaminant can build up in the drug when stored for long periods."[6] Heavy marketing expenditures resulted in Zantac being consumed by those who might have satisficed with less harmful alternatives.[9] As the potential harmful effects were identified, lawsuits were filed.

## Oversight

By the time of the FDA's 1983 provisional approval for Zantac, it had already been approved for sale in 31 counties.[17] Marketing expenditures were measured by hundreds of millions of dollars.[18][13][19]

The 2019 New York Times headline "Heartburn Drugs Can Lead to Fatal Heart or Kidney Disease"[20] was a herald for Zantac being pulled from store shelves.[1]

### Infants and children

A lower dose version of Zantac[9] had been given to children. A liquid form for ingestion by infants also had been marketed.[6]

## Lawsuits

By 2022, a wave of Class action lawsuits was underway, and illegal robocalls were being made, even to those registered on the Federal Do-Not-Call list regarding settlement options.[citation needed] Also by then, "a wave of recalls" had taken place.[21]

Some of the lawsuits, which by October 2021 included over 100,000 plaintiffs,[5] were filed due to impending statute of limitations laws; estimates of how many people used Zantac have been given as high as 15 million.[citation needed] Facets of the legal rangling included:

* whether or not certain internal eMails were privileged[22] (and that deleting them was or was not a violation of a judge's orders to preserve them).[23]
* voluntary withdrawal of products and whether this removed them from oversight.[5]

Related to courtroom action were offers for a cash advance on impending settlements. Another money matter related to lawsuits and impending settlements is market timing.[24]

In June 2023, GSK reached a confidential settlement for one of the lawsuits related to Zantac causing cancer. [25][26]

## Zantac pill switching settlements

In 2008 settlements were reached regarding switching Medicaid patients taking Zantac from capsules to the "more costly" tablet form. [27] [28]

## See also

* Zantac 360 (Famotidine)
* List of largest pharmaceutical settlements

## References

1. ↑ 1.0 1.1 Sandra E. Garcia (September 30, 2019). "Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears". The New York Times. https://www.nytimes.com/2019/09/30//health/zantac-recall-cancer.html.
2. ↑ Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S., October 23, 2019, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us
3. ↑ Katie Thomas; Sheila Kaplan (September 13, 2019). "Zantac Has Low Levels of a Cancer-Causing Chemical". The New York Times. https://www.nytimes.com/2019/09/13/health/zantac-cancer-ndma.html.
4. ↑ Katie Thomas (October 18, 2019). "Zantac Recall Widens as Sanofi Pulls Its Drug Over Carcinogen Fears". The New York Times. https://www.nytimes.com/2019/10/18/health/zantac-recall-carcinogen-sanofi.html.
5. ↑ 5.0 5.1 5.2 Nate Raymond (October 7, 2021). "Sanofi, GSK can't escape Zantac proposed class actions, judge rules". Reuters. https://www.reuters.com/legal/litigation/sanofi-gsk-cant-escape-zantac-proposed-class-actions-judge-rules-2021-10-07.
6. ↑ 6.0 6.1 6.2 Katie Thomas (April 1, 2020). "Zantac Products Should Not Be Sold or Used, F.D.A. Warns, Citing Cancer Danger". The New York Times. https://www.nytimes.com/2020/04/01/health/zantac-cancer-fda.html.
7. ↑ Steve Lohr (March 31, 1986). "Ulcer Drug Succeeds, but GLAXO Won't Relax". The New York Times. https://www.nytimes.com/1986/03/31/business/ucler-drug-succeeds-but-glaxo-won-t-relax.html.
8. ↑ Elsie Dragonetti (June 18, 1989). "The Zantac Saga Includes the Cost". The New York Times. https://www.nytimes.com/1989/06/18/sports/l-the-zantac-saga-includes-the-cost-025189.html.
9. ↑ 9.0 9.1 9.2 9.3 Steven Prokesch (October 11, 1989). "Glaxo's Search: Son of Zantac". The New York Times. https://www.nytimes.com/1989/10/11/business/glaxo-s-search-son-of-zantac.html.
10. ↑ "Reader Responses". The New York Times. October 18, 2006. https://www.nytimes.com/2006/10/18/business/18leonhardt-responses.html.
11. ↑ Christina Caron (April 18, 2020). "Should Pregnant Women Avoid Zantac?". The New York Times. https://www.nytimes.com/2020/04/18/parenting/pregnancy/zantac-recall.html.
12. ↑ "No Prescription Needed: Zantac, the ulcer medicine". The Los Angeles Times. December 22, 1995. https://www.latimes.com/archives/la-xpm-1995-12-22-fi-16800-story.html.
13. ↑ 13.0 13.1 Stuart Elliott (April 23, 1996). "Madison Avenue girds itself for Z-Day today". The New York Times. https://www.nytimes.com/1996/04/23/business/media-business-advertising-madison-avenue-girds-itself-for-z-day-today.html. "with a budget estimated at $100 million -- for Zantac"
14. ↑ "Public Faces Overdose of Similar Drug Names". The Los Angeles Times. November 18, 1994. https://www.latimes.com/archives/la-xpm-1994-11-18-fi-64372-story.html. "Quick, what was that prescription your father takes for his ulcer? Zantac? Xanax? Zenate?"
15. ↑ "Generic Zantac Marketing Pact". The New York Times. August 5, 1997. https://www.nytimes.com/1997/08/05/business/generic-zantac-marketing-pact.html.
16. ↑ Mary Duenwald (February 22, 2005). "Heartburn Relief, From Aciphex to Zantac". The New York Times. https://www.nytimes.com/2005/02/22/health/heartburn-relief-from-aciphex-to-zantac.html.
17. ↑ Barnaby J. Feder (May 7, 1983). "GLAXO says Ulcer Drug has Approval of F.D.A.". The New York Times. https://www.nytimes.com/1983/05/07/business/glaxo-says-ulcer-drug-has-approval-of-fda.html.
18. ↑ Milt Freudenheim (September 8, 1995). "War on Heartburn Heats Up With Over-the-Counter Blitz". The New York Times. https://www.nytimes.com/1995/09/08/business/war-on-heartburn-heats-up-with-over-the-counter-blitz.html. "A $200 million-plus marketing battle has started"
19. ↑ "RKS;ZANTAC ARRIVES WITH $100 MIL CAMPAIGN". Advertising Age. April 29, 1996. https://adage.com/article/news/landmarks-zantac-arrives-100-mil-campaign/79448.
20. ↑ Nicholas Bakalar (June 11, 2019). "Heartburn Drugs Can Lead to Fatal Heart or Kidney Disease". The New York Times. https://www.nytimes.com/2019/06/11/well/live/heartburn-drugs-can-lead-to-fatal-heart-or-kidney-disease.html.
21. ↑ Christina Jewett (March 23, 2022). "Pfizer Recalls Some Blood Pressure Drugs, Citing Cancer Risk". The New York Times. https://www.nytimes.com/2022/03/23/health/pfizer-recall-blood-pressure-drug-cancer.html.
22. ↑ "Sanofi claws back some Zantac emails as privileged". Reuters. July 9, 2021. https://www.reuters.com/legal/litigation/sanofi-claws-back-some-zantac-emails-privileged-2021-07-09.
23. ↑ Jef Feeley (May 11, 2021). "Sanofi Accused of Destroying Emails Tied to Zantac Recall". https://www.bloomberg.com/news/articles/2021-05-11/sanofi-accused-of-destroying-internal-emails-about-zantac-recall.
24. ↑ Anthony Ramirez (November 5, 1995). "INVESTING IT;Will It Please the Court? A Litigation Analyst Calls the Verdicts". The New York Times. https://www.nytimes.com/1995/11/05/business/investing-it-will-it-please-the-court-a-litigation-analyst-calls-the-verdicts.html. "buying the stock when it dips following negative litigation news"
25. ↑ "GSK Settles First Zantac Cancer Lawsuit Set for Trial in US" (in en). Bloomberg.com. 2023-06-23. https://www.bloomberg.com/news/articles/2023-06-23/gsk-gsk-ln-settles-first-zantac-cancer-lawsuit-set-for-trial-in-us.
26. ↑ "GSK settles key Zantac cancer lawsuit" (in en). The Times. 2023-07-10. ISSN 0140-0460. https://www.thetimes.co.uk/article/gsk-settles-key-zantac-cancer-lawsuit-kq5jsgj37.
27. ↑ "Walgreen Settles Suit On Pill-Switch Claims". The Wall Street Journal. June 5, 2008. https://www.wsj.com/articles/SB121259276426645179.
28. ↑ "CVS Caremark Reaches Settlement". The Wall Street Journal. March 19, 2008. https://www.wsj.com/articles/SB120585417674445335.

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