There was a time when Zantac (ranitidine) was the most prescribed medicine in the world. Now Zantac is going onto the scrap heap of discarded drugs.
This heartburn medicine was considered a highly effective acid suppressor with few, if any significant side effects. It was launched in 1981.
Tens of millions of people were prescribed Zantac. When it lost its patent, millions more received prescriptions for the generic formulation called ranitidine. When it went over the counter, more millions played doctor and took the drug for symptoms of heartburn.
The Early Warning:
Valisure is an online pharmacy in New Haven, Connecticut. It tests each lot of medicine that it sells. After nitrosamine contamination of popular blood pressure medicines such as irbesartan, losartan and valsartan was revealed, the company started testing other drugs for nitrosamine.
When Valisure tested Zantac and generic ranitidine, the testing lab was shocked at what it discovered. The pharmacy notified the FDA in June of 2019 that there was a problem with this drug. Many samples contained the nitrosamine carcinogen NDMA at scary levels.
The Petition To Remove Ranitidine:
On September 9, 2019, Valisure sent the FDA a Citizen Petition on Ranitidine.
It said in part:
“Valisure tests all batches of all its medications for quality and consistency issues and through such tests detected extremely high levels of N-Nitrososdimethylamine (“NDMA”), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”
The pharmacy called upon the FDA to:
“…recall and suspend sales of ranitidine from the US market.”
The FDA Responds:
The Food and Drug Administration responded quickly for that agency.
On the 13th of September, 2019, the FDA said it had learned that:
“…some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.”
The FDA went on to say that:
“When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available.”
The FDA made it seem as if the levels it found were hardly anything to worry about:
“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”
Zantac is Going…Gone in Europe
By October of 2019, most countries in Europe had recalled ranitidine. So had Australia, Canada and many other countries. The FDA continued to reassure Americans that the levels of nitrosamines in ranitidine were roughly comparable to the amounts you might consume in smoked or grilled meat. In other words, don’t worry, be happy.
The FDA Flip-Flop on April 1, 2020:
On April Fools’ Day, 2020 the Food and Drug Administration said:
“FDA Requests Removal of All Ranitidine Products (Zantac) from the Market”
“The agency has determined that the impurity [NDMA] in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.”
“With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine requesting they withdraw their products from the market. The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.”
Take a look at the date the FDA issued this recall request. Yup, April 1, 2020.
When did the FDA state?
“When the agency identifies a problem, it takes appropriate action quickly to protect patients.”
Right, that was on September 13, 2019. Do you consider that quick and appropriate action? What took the FDA so long to decide Zantac is going, going, gone?
A Dirty Little Secret About Removal Requests:
The FDA does not have the authority to actually ban drugs that have formulation problems. Very few health professionals realize that. The best the Food and Drug Administration can do is request that companies voluntarily recall a problem medicine.
This is very different from other countries. If Australia, Germany or France decide a drug poses a risk, they can ban it almost instantly. In the U.S., the FDA “requests.”
Joe Goes to Washington:
On January 10, 2020, I went to Washington, DC, to join Congresswoman Rosa DeLauro and other experts in calling for a ban on ranitidine sales. At that time she reintroduced the Recall Unsafe Drugs Act.
She wanted the FDA to be able to have mandatory recall authority over products:
“that have been found to cause serious health consequences or death. As Valisure and its research partners have found in their research, this problem extends to popular drugs like Zantac. People deserve to know that the medication they are using is safe. As a regulatory agency, the FDA needs to thoroughly review the safety of drugs before they come to market and while they are on the market. Anything short of that is a failure that puts lives at risk.”
To my amazement, the FDA does not seem to want mandatory recall authority over drugs. That seems bizarre, but the FDA is the FDA. At least Zantac is going, along with generic ranitidine products. Of course, this assumes drug companies comply with the voluntary recall request.
What do you think of this FDA announcement? Please share your thoughts in the comment section below.
Micki shared this comment back on Oct. 10th, 2019:
“The FDA has shown their lack of concern for our health and now this. I am worried about the Zantac recall [the agency did request a recall of some ranitidine products back in the fall]. I questioned my pharmacy on this as I am taking Zantac. Their answer was they ‘have no answer.’ Very scary.
“My pet dog is also on liquid Zantac. Am I giving her a daily dose of cancer? All Zantac should be removed until they can absolutely rule out carcinogenic concerns.”
You can read our initial special health alert from September, 2019 at this link. We have continued to update the warning and we are glad that Zantac is going. We do worry about other drugs that may also have unacceptable levels of nitrosamines. More about that in future newsletters.