Three more heartburn drugs recalled over carcinogen fears

By | January 10, 2020

Three more heartburn drugs recalled over fears they contain cancer-causing chemicals that some scientists now think could form if Zantac is left in hot cars or homes

  • Two generic forms of Zantac and a third, similar drug were recalled this week after their makers discovered trace amounts of the carcinogen NDMA
  • Appco Pharma and Denton Pharma recalled their ranitidine 
  • Mylan also issued a voluntary recall of its antacid nizatidine
  • A California lab’s tests suggest the chemical forms when ranitidine is heated  

Three more heartburn drugs have been recalled over fears they contain the cancer-causing chemical, NDMA. 

Both Appco Pharma and Denton Pharma (which sells its drugs under the name Northwind) issued voluntary recalls this week of their ranitidine products – generic forms of the popular heartburn drug, Zantac. 

Food and Drug Administration (FDA) officials also said that Mylan had issued a recall of its heartburn drug nizatidine, another antacid, after finding traces of the same carcinogen were found in batches of it. 

Meanwhile, chemists at California‘s Emery Pharma lab have been painstakingly studying ranitidine and the processes used to produce heartburn drugs and now believe that NDMA may form as a byproduct of heating the active ingredient, CBS News reported.  

Another three heartburn drugs have been recalled after traces of the probable carcinogen NDMA were found in them, the FDA announced this week

Another three heartburn drugs have been recalled after traces of the probable carcinogen NDMA were found in them, the FDA announced this week 

Recalls of Zantac and its generics started rolling out in September of last year – and have slowed but not stopped since. 

Now, hundreds of batches of ranitidine drugs have been recalled.  

The panic over ranitidine is due to amounts of a carcinogen called NDMA above the level deemed safe by US regulators found in the popular heartburn drugs. 

NDMA – the short-hand for N-Nitrosodimethylamine – is labelled a ‘probable’ human carcinogen, and has caused liver, lung and other cancers in animal studies. 

A number of theories have been put forward to explain how the toxic chemical ended up in the supply of some heartburn medications, as well as in the blood pressure drugs, valsartan and losartan, in recent years. 

Some have suggested it’s a result of shoddy manufacturing. 

Others initially suggested that the way the body metabolizes the drug could actually make levels of NDMA surge in the stomach, but that theory was debunked in November, to the relief of heartburn sufferers. 

Now, Emery’s chemists believe that heat may be the trigger for the production of NDMA. 

Emery’s team heated samples of ranitidine over the course of 12 days, CBS News reported. 

While its NDMA content met safety standards (below 96 nanograms) at room temperature, once heated to 158 degrees F, NDMA levels rose to 142 nanograms. 

‘So if someone were to keep their ranitidine, Zantac, in their car for example and in the middle of summertime, that product is going to get heated up and it’s going to generate this compound,’ Emery chemist Ron Najafi told CBS. 

‘So NDMA in this case… is not an impurity in the drug, it’s being formed from the drug itself.’ 

That’s worrisome in that it means no manufacturing tweaks would prevent NDMA from forming in ranitidine if the drug gets hot. 

On the other hand, the FDA’s drug evaluation chief, Dr Janet Woodcock, told CBS that it’s too soon to tell if ranitidine is realistically reaching high enough temperatures on a consistent basis for this to be the cause of the carcinogen’s production, or public concern. 

‘The question about whether ranitidine would need to be kept cold to keep it from converting, is something that still hasn’t been answered,’ Dr Woodcock said. 

Najafi and his team have submitted the results of their tests to the FDA, but regulators have not yet reviewed the findings.  

Health News | Mail Online