Zantac es cancerígeno?

 

On the heels of recent recalls, both consumers and the medical community have been asking “does Zantac cause cancer?” and the answer is quite possibly yes. A small pharma lab in Connecticut discovered evidence suggesting that the active pharmaceutical ingredient (API) in ranitidine is inherently unstable and can transform into the carcinogen NDMA under the right conditions.

Heartburn medications containing ranitidine, such as Zantac, have been recalled 14 times since September. This issue is a serious concern for approximately 15 million Americans who have prescriptions for ranitidine – as well as millions of others who take a low dose over-the-counter version on a regular basis.

People who have been taking Zantac may have a number of questions: 

• What kind of cancer does Zantac cause? 
• How does Zantac cause cancer? 
• And what is the Zantac cancer risk?   
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What Is the Zantac Cancer Risk?

A growing number of patients are coming forward with claims of Zantac cancer risk caused by the impurity known as NDMA, an abbreviation for N-Nitrosodimethylamine. NDMA is a byproduct of numerous industrial processes, including the manufacture of jet fuel. NDMA is also found in a number of food products (such as smoked meats), tobacco and certain pesticides. A potent hepatotoxin (affecting the liver), NDMA has been shown to cause tumors in several organs of the body. NDMA is considered a probable human carcinogen, or substance capable of causing cancer in humans.

How Did NDMA Get Into prescription drgus?

How does Zantac cause cancer? 

It’s not by virtue of the drug itself being carcinogenic. Instead, it’s because of contamination with the NDMA impurity.

NDMA has been found in a number of different drugs. In 2018, it was detected in a class of blood pressure medications, known as angiotensin II receptor blockers (ARBs). The U.S. Food and Drug Administration (FDA) believes NDMA contamination occurred during the manufacturing process when certain ingredients were used that were not meant to be part of the final product. Letters from the FDA to these drug makers indicate that these ingredients were not completely “purged,” or that recycled materials used in the process (solvents and catalysts) came into contact with equipment that had not been cleaned properly.

NDMA was found in ranitidine at Valisure, a small, independent testing lab for pharmaceutical products. To confirm its findings, Valisure sent a ranitidine sample to a second lab in California, Emery Pharma. Scientists at Emery not only confirmed the existence of NDMA in ranitidine, but they also found that the problem was with the molecule itself, not contamination from an outside source. It turns out that ranitidine can actually turn into NDMA when exposed to warm temperatures.

Levels of NDMA discovered in Zantac were found to be up to 26,000 times greater than the FDA-approved limit of 0.32 parts per million.

“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health,” the FDA noted in a statement issued about NDMA risk. “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.” Más

Ver también:

The Facts on the Connection Between Zantac, NDMA, and Cancer Lawsuits