Headaches Ahead for Zantac Labs
June 4, 2020 | Pharmaceutical Litigation
As recently as August 2019, the ranitidine market was tipped to top a gut-gripping US$ 485.4 million by 2026.
Introduced in 1981, this popular antacid – better known as Zantac – was the world’s top-selling prescription drug just six years later.
In fact, sweetening the world’s sour stomachs proved a bottomless well of unprecedented profits, with Zantac being the first drug to generate sales topping US$ 1 billion.
With sales figures soaring steadily from the 1980s onwards, digestive disorders seemed a surefire path to ongoing global success.
In August 2018, the latest arrival on this bubbling market was generic 150 mg Cool Mint, an OTC ranitidine generic made by Granules India Ltd and approved by the FDA in August 2018 as bioequivalent to the 150 mg Zantac tablets made by Sanofi-Aventis.
But this blister-pack castle began to crumble the following year, when a September announcement from the FDA highlighted the link between cancer and a Zantac ingredient (NDMA).
Although covering only specific lots made by one manufacturer, this red light prompted many Main Street retailers (like CVS and Walgreens) to pull Zantac and its OTC generics from their shelves.
As doubts about its safety loomed even larger, generic drug producers like Sandoz (Novartis), GlaxoSmithKlein (GSK) and Apotex also recalled their ranitidine hydrochloride products.
The following month, the world’s largest generic drug producer, Teva Pharmaceuticals recalled batches of ranitidine in the UK, while Sanofi recalled products in Canada and the USA.
Since then, at least 22 countries have followed suit, banning, blocking or recalling ranitidine hydrochloride, while four others issued warnings and launched their own investigations.
In January 2020, the FDA recalled two more prescription types of ranitidine, and in April 2020 it banned all prescription and OTC forms of this drug, including Zantac.
For four decades, Zantac has been protecting bilious stomachs from acid-production signals.
Some of the more common ranitidine brands include Zantac (in various strengths and flavors); Wal-Zan, Heartburn Relief, Acid Reducer and Acid Control.
Belonging to the histamine H2-receptor antagonist class of drugs that bring stomach acid under control, Zantac is an H2 blocker that blocks the signal telling the stomach to produce acid.
Available on prescription and over-the-counter and commonly taken for heartburn, acid reflux, ulcers and other digestive issues, Zantac can also supplement allergy treatments.
Dating back to the 1980s, many studies demonstrated links between cancer and the NDMA in ranitidine.
There is also mounting evidence purportedly indicating that the two Big Pharma firms making Zantac (Sanofi and Boehringer Ingelheim) concealed these links from millions of patients taking this drug for ailments ranging from simple heartburn to gastroesophageal reflux disease (GERD).
Finding unacceptably high NMDA levels in ranitidine, two laboratories – Emory Pharma and Valisure (an online pharmacy that batch-tests the medications it sells) – filed citizen petitions urging the FDA to suspend sales.
When testing widely-used Zantac 150 tablets, the FDA found NMDA at levels up to 3,000 times higher than its daily intake ceiling.
Today, it is believed that there is no safe level of NDMA for human consumption.
After this revelation, thousands of cancer patients are seeking restitution, filing suit against Sanofi and Boehringer Ingelheim for their willingness to put profits before people, with reckless disregard for human life.
In response, both laboratories have offered refunds to consumers purchasing Zantac.
What is NMDA?
Prompted by information from third party laboratories, further FDA testing and assessment confirmed that N-Nitrosodimethylamine (NDMA) levels can increase in ranitidine, even under normal storage conditions.
At higher temperatures – which are less easy to control during distribution and display to consumers – NDMA may increase significantly.
As these impurities increase with age, older ranitidine medications may contain more NDMA than the daily intake ceiling, especially when stored at higher than room temperature.
This may lead to consumer exposure to unacceptable levels of this human carcinogen.
With the COVID-19 lockdown not yet fully lifted, consumers are asked to dispose of unused tablets safely, as recommended on the package insert, or follow FDA recommendations.
Assorted side effects
Although generally mild, some side-effects of ranitidine can cause significant distress, including headache, nausea and vomiting.
Far more serious, high levels of NDMA – a known carcinogen – can cause cancer throughout almost the entire body, including prostate, testicular and bladder cancers; breast, cervical and ovarian cancers; kidney, liver, stomach and bowel cancers; and throat, esophageal and lung cancers – even among non-smokers!
People taking ranitidine are advised to explore other treatment options with their healthcare practitioner, as many other drugs have been approved for similar purposes, but without the risk of cancer.
So far, FDA tests have found no NDMA in other H2 blockers like Pepcid (famotidine) and Tagamet (cimetidine).
Other options include proton pump inhibitors (PPIs) like Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole).
Once some patients start taking these medications and note few side-effects, they may never stop.
Although usually well tolerated, they might not be needed for dealing with heartburn over the longer term.
Despite being notoriously difficult to maintain, lifestyle changes can help reduce the need for H2 blockers and PPIs.
Avoiding fatty and spicy foods, alcohol, caffeine, chocolate and carbonated drinks is an obvious decision, together with eating smaller meals and losing weight.
Perhaps easier to implement, wearing looser clothing, not lying down for a couple of hours after eating, and sleeping on a slightly down-tilted bed are simple steps that help prevent acid reflux.
Sold as both a prescription and over-the-counter drug for decades, any Zantac litigation has hundreds of thousands of potential plaintiffs, each filing a separate lawsuit.
However, these proceedings streamlined through combining them into multi-district litigation (MDL) under a single judge who presides over every case during the pre-trial stage.
Known as bellwether trials, a few initial cases are heard, to determine whether settlements will be awarded, and for how much.
These decisions guide how much each plaintiff receives, based on individual factors.
At the moment, there is only one Zantac MBL (Nº 2924), filed in West Palm Beach, it is being heard by Judge Robin L Rosenberg.
So far, the defendants include GlaxoSmithKline, Sanofi-Aventis, Pfizer Boehringer Ingelheim and Chattern.
Although under way for only a few weeks, claims are surging.
A practices and procedures team is already establishing litigation protocols and methodology for handling the tens of thousands of lawsuits expected during the years ahead.
Moreover, NMDA has also been detected in some blood pressure medications, which may well – sometime down the road – prove one of the more expensive ramifications of the FDA ban.
Perhaps not topping the 1998 tobacco master settlement agreement award of USD 206 billion, there is a fair chance that the Zantac payout will set a new record in the pharmaceutical sector, outstripping the US$ 3 billion paid out by Glaxo in 2012 for misrepresenting its antidepressants.
At this stage, the medical, legal and financial consequences of the Zantac ban are too vast to predict.
However, it seems likely that the management of laboratories making this popular antacid will need far stronger remedies to soothe the dyspeptic discomfort caused by the firestorm of well-founded claims about to sweep through the US Courts.
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