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Zantac: How one common medication caused the public outcry

by Staff writer
09 Mar 2021 at 20:33hrs | Views
The phrase health is wealth will never be any truer. This is why we seek medical attention whenever we fall sick or feel ill. Sometimes a trip to the pharmacy across the street will do the trick, whereas some ailments require proper investigation and treatment. In most of these cases, however, we need medication to restore wellness and good health. But what happens if the medications you are given expose you to health risks worse than your current concerns? Well, we can only relate to this with a classical example by taking a look at how a popular drug caused public outcry the world over.



For several years now, Zantac, a drug that falls in the ranitidine category has helped treat and alleviate symptoms in ulcers and heartburn patients. The drug is easily obtained either from the stores over the counter or through a prescription by the doctor. Recently, however, an unpleasant realization occurred regarding the drug, Zantac was suspended from production and distribution to the market, following the claim the drug (Zantac) and other H2 blockers were alleged to contain N-Nitrosodimethylamine (NDMA), a proven carcinogen. With such a claim in the air, the manufacturers of the drug have been in and out of court versus the public and previous consumers.

To better understand the magnitude of the situation, let us look at the details below.

What Is Zantac And How Does It Work?

As earlier mentioned, this drug has been used to treat ulcers and heartburn for quite some time now. Falling in the category of H2 blocker drugs, it works by reducing the amount of acid produced by the stomach. Normally, the stomach has a compound known as Histamine (H2). When there is food in your stomach, histamine encourages the stomach to produce acid to aid in digestion. Sometimes, histamine stimulates the production of the acid even when there is no food in the stomach. When that happens, the acid tends to eat away the stomach surfaces, leading to wounds that are commonly referred to as ulcers. This is where the ranitidine drugs come in.

Being a histamine (H2) blocker, the drug reduces the amount of acid produced by the stomach. This means the stomach won't be producing any acids that would otherwise eat away the walls of the stomach. The drugs are, therefore, meant to prevent the ulcers from coming back after they have healed. Other than ulcers, the drug is known to treat or rather prevent throat problems such as erosive esophagitis, gastroesophageal reflux, and Zollinger- Ellison syndrome.

A Brief History Of Zantac

From a renowned manufacturer known as GSK, Zantac is said to have been first sold back in 1983. Various sources indicate that by 1988, it had become the world's best-selling drug in the pharmaceutical market. By 2004, over-the-counter versions of Zantac had been approved for the treatment of heartburn. This was after generic versions of the drug started storming the market upon the expiry of GSK's patent to the original drug in 1997. It was considered safe for several decades until it was disclosed to pose cancer risks to its consumers. Much of this realization came to light in 2019, more than three and a half decades after Zantac was introduced into the market.

The drug Zantac became even more popular after it was determined to contain a popular carcinogen, a compound known as NDMA. Needless to mention, the drug had some other side effects before its carcinogenicity was discovered. Let us take a look at them below.

Initial Side Effects Of Zantac

The most common side effects of the drug include the following:

-    Headache
-    Constipation
-    Diarrhea
-    Dizziness
-    Lightheadedness
-    Sleep problems
-    Fatigue
-    Low sex drive

Sometimes these effects are so severe that they require one to visit a doctor. Depending on the person, one might experience mental changes such as agitation, depression, or even hallucination. Some people have complained of blurred vision, enlarged breasts, irregular heartbeat, and abdominal pains. The latter signs require you to visit your doctor. The drug is said not to have any known allergic reactions, but it is always advisable to see a doctor when you notice something strange such as a rash, itching, swelling, or trouble breathing. This list is nonetheless, not exhaustive.

All the same, the above side effects were known long before the FDA recalled the production and distribution of Zantac.

The Zantac Case

Until recently, the Zantac drug has been effective in treating ulcers and reducing heartburn. In 2019, the Food and Drug Administration (FDA) suspected that there were people who had been diagnosed with cancer, and what was common between them was that they were under Zantac. The FDA, therefore, held some preliminary investigations on the drug and all other ranitidine drugs. Later, the FDA results revealed that the drug had significant amounts of the compound N-nitroso dimethylamine (NDMA). The compound was no danger until it was stored under temperatures higher than room temperatures. At this level, the compound heightened to dangerous levels acquiring carcinogenic properties.

Upon the identification of the issue, the FDA issued a warrant to all the manufacturers of Zantac and all other ranitidine drugs, asking them to withdraw all their drugs from the market due to the issue at hand. Most companies recalled their products while others didn't. Since the research was still ongoing and nothing concrete on the drugs had come up yet, users were advised to use the drugs at their own risk. This realization has since introduced quite an amount of lawsuits against the manufacturers of this drug. As you would expect, the number of people searching for information about the Zantac lawsuit 2021 settlement amounts will bewilder you. More interestingly, these lawsuits have not only affected the original manufacturers. Since ranitidine comes in many different shapes and sizes, dozens of generic manufacturers were also affected and ended up recalling their drugs from the distribution chain in fear of these lawsuits. In most of these cases, two main claims are common against the producers of Zantac… that:

-    The drug had a defective design
-    The manufacturers knew the risks but didn't warn the public

Early this year in the now popular Zantac lawsuit, a court ruled that the manufacturers of the Zantac drug knew the possible risky effects but decided to withhold the information from the public as this would have made them reluctant to acquire the drug. The ruling also indicated that anyone who might have been in any way affected by the drug could file a claim in pursuit of compensation. As of 2021, the number of people coming up with claims of being victims to Zantac is increasingly growing. Given the popularity of the heartburn drug, this raises the alarm to just how much the drug might have affected the globe as a whole.

The Zantac Cancer Risk

The association of the drug with cancer is due to the presence of the compound N-nitroso dimethylamine in the drug. As earlier mentioned, when NDMA is exposed to temperatures higher than RTP, it tends to reach dangerous levels.

Studies

Other than in the drug, NDMA occurs naturally as a contaminant, which is found mainly in water, dairy products, and grilled meat. This is known as environmental nitrosamine, which has been proven by studies to potentially target breast cells and other cells in the body. When the FDA was researching the compound, they mainly used animals as test subjects. So far, limited studies (or none) have been studies done on humans, which could be handicapping the certainty of the claims made on the drug.

Nonetheless, the number of people found to be suffering from cancer or tumors while or after using the drug was still significant enough to warrant its recall. Some studies have also established a connection between pancreatic cancer and N-Nitroso compounds such as NDMA. The development of liver fibrosis has also been cited in studies.

Exposure To Low Amounts

NDMA has no effects on the human body when in low amounts. The risk becomes higher when users are exposed to high amounts of the compound or with long-term use of ranitidine. While most of the ranitidine drugs have the compound in them in low amounts, something happens when the drugs are stored in temperatures higher than room temperature. The level of NDMA elevates to levels that could trigger the growth of tumor cells.

When one is exposed to the compound after it has attained its carcinogenic properties, consumers tend to have complications such as the growth of tumors in areas such as the lungs, the kidney, liver, and stomach.

The FDA Input

Zantac and other ranitidine drugs are still under study to determine how much risk there is when someone is exposed to the compound NDMA. This means that any information that has been released regarding the effects of the drug is still not ultimate. The FDA has, however, claimed that the risk of acquiring cancer from the drug is quite high. This is why the food and drug regulator instructed all American producers of the drug to withdraw their products from the market and cease its production.

Warnings On The Use Of The Drug

While the FDA in America has instructed the withdrawal of the drug from the market, Zantac is pretty much still available on the shelves in pharmaceutical stores around the globe. This means that many consumers in the global public are still using them. For that reason, warnings about the continued use of the drug have been issued worldwide.

Most of these are circulated through advisories via the relevant health organizations, drug regulators, and health facilities. The warnings are also meant to put the public in the know, informing them that the continued use of the drug is their personal choice. This means that their safety is their responsibility as well.

What About Short Term Use?

Zantac and other ranitidine drugs with the compound NDMA pose a cancer risk – that is crystal clear at this point. However, it is also clear that the risks are only imminent when one has used them for a long time or has been exposed to high levels. This means that the drug can still be safe to use but for a limited amount of time and in minimal doses.

This information is critical to people who have been using the drug for quite some time and are having trouble finding an alternative. Such individuals should seek consultation from their physicians regarding whether they still need these drugs. If ranitidine medication is still needed, it is prudent to ask your doctor about the available alternatives, so you can avoid the risks mentioned. These would include medications approved by the FDA as alternatives to Zantac, including the following:

-    Nexium
-    Prevacid
-    Tagamet
-    Prilosec
-    Pepcid

Simply put, several H2 blockers in the market can do the same job or even better without exposing the consumer to cancer risks. Alternatively, since these drugs are used to treat lifestyle illnesses, a change of lifestyle would be a better approach. For example, you can talk to your doctor about some of the foods to avoid or what to include in your diet to better your condition. Things like honey, garlic, and certain veggies can have numerous benefits when it comes to treating your peptic ulcers, heartburn, and other GIT conditions. Lifestyle changes may also involve avoiding acidic foods or substances that trigger acidity in the first place. As you may already know, avoiding alcohol and alcohol-containing products can go a long way in improving your digestive health.

The Zantac drug has had several allegations, some of which have been confirmed and others that are still under investigation. While no conclusion has been made on the effects of the drug, the fact that the NDMA is present cannot be ignored. Being associated with cancer raises concern about the credibility of Zantac as a drug. The 2021 court ruling on Zantac made the drug recalled from the American market. Other ranitidine medications were taken in for analysis and further research as well. While some people are still using the Zantac drug, health institutions urge the public to make mindful decisions regarding using it.


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