In the wake of Zantac recalls, the Food and Drug Administration (FDA) assured Americans that alternative heartburndrugs like Pepcid, Nexium, Prilosec and Prevacid are safe and do not contain cancer-causing chemicals, the agency said Wednesday.
Last month, Zantac and its generic, ranitidine, tested positive for NDMA, a chemical linked to colon, gastric, kidney and liver cancers.
Major retailers like Walmart, CVS and Walgreens quickly pulled the drugs from their shelves, and distributors outside the US voluntarily recalled the drugs in Europe and Asia. Its US maker, Sanofi, finally followed suit last week.
In the wake of the findings, the FDA notified the Americans that five other popular over-the-counter heartburn drugs have been previously tested and do not contain NDMA – though some may carry other risks, including early death.
The FDA advised that patients taking prescription Zantac or ranitidine should speak to their doctors about whether or not to switch to other drugs so that their physicians can help them weigh the benefits and risks of a change.
On Wednesday the FDA advised that at least five alternatives to Zantac – including Pepcid, Tagamet and Prilosec are free of the cancer causing chemical in Zantac. But the other popular options may come with their own risks, including early death, if taken long term
‘Consumers taking OTC ranitidine, which is used to prevent and relieve heartburn associated with acid indigestion and sour stomach, may consider using other OTC products approved for their condition,’ the agency wrote in a statement.
‘FDA’s preliminary tests of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) show no NDMA in these tested medicines at this time.’
THERE ARE ALTERNATIVES TO ZANTAC – BUT THEY MAY CARRY THEIR OWN RISKS
Zantac and ranitidine are known as H2 blockers, a class of heartburn drugs that have gained favor in the eyes of providers in recent years.
Studies have suggested that one of the other main groups of heartburn medications – a class called proton pump inhibitors (PPIs) – may pose risks by disrupting the way the body absorbs certain nutrients.
They’ve also been linked to higher risks for heart and kidney disease, stomach cancer and C diff infections in some patients.
One recent Washington University, St Louis, study found that people who took PPIs for months or years were at a 17 percent higher risk of death compared to patients who took H2 blockers.
PPIs, which include Nexium and Prilosec, work by suppressing the final stage of acid release in the stomach, where as H2 blockers prevent some acid from being released by interfering with receptors involved in the earlier stages of the digestion process.
Aside from the potentially carcinogen-laced Zantac, other H2 blockers include nizatidine (Axid), fanotidine (Pepcid and Pepcid AC), and cimetidine (Tagamet and Tagamet HB).
Axid was not mentioned by name in the FDA’s statement, but it confirmed that no NDMA has been found in the H2 blockers Pepcid or Tagamet, nor has the carcinogen been detected in several popular PPIs.
It’s for patients and their doctors to weigh the risks and benefits of each of these drugs.
WHAT IS NDMA, THE CANCER-LINKED TOXIN FOUND IN ZANTAC?
NDMA is the acronym for N-Nitrosodimethylamine, a chemical byproduct of many industrial manufacturing processes.
The compound can be disruptive to DNA, which may cause cancer.
It doesn’t degrade, or break down, naturally in the environment or our bodies, meaning that it accumulates over time and our exposures only build up, earning it the nickname ‘forever chemical.’
NDMA is created in the production of rocket fuel, from which it has leached into our water supply.
It’s also common in low quantities in many foods, such as cured or smoked meats, fish and beer as well as tobacco smoke.
Animal studies have shown the chemical to cause colorectal, kidney, stomach and kidney cancers at high exposures.
In humans, on the other hand, studies have only linked the chemical to higher risks of cancers.
No human cases of cancer caused by NDMA have been reported, and the World Health Organization (WHO) considers it a ‘probable’ human carcinogen.
Earlier this year, it was found in an entire class of blood pressure drugs – the most widely known of which is valsartan – leading to worldwide recalls and shortages, despite the FDA’s statement that the drug poses limited risks.
‘There have been no adverse events’ linked to Zantac, Dr Inna Hussain, head of laryngology at Rush University Medical Center told DailyMail.com.
‘The concern is that at high enough doses, NDMA can be carcinogenic, but what does isn’t clear.’
We don’t know yet if NDMA got into ranitidine during its production or if the toxin is a byproduct of the drug itself.
It could be that Zantac ‘is breaking down and becoming NDMA, which is much more concerning,’ said Dr Hussain.
She notes that it’s those who use the drug continuously for the management of chronic heartburn who are likely to be at the greatest risk.