The advancements in the medical industry helped many people get treatments for their illnesses. Various medical procedures and medications were developed to help individuals recover from their health complications.
Some common problems like ulcers and acid reflux are easier to manage with the help of medicine. One well-known drug that became popular in recent years is Zantac. It’s an accessible and affordable oral tablet that can be purchased by individuals dealing with gastrointestinal issues or ulcers.
Although the drug’s benefits seemed promising to many consumers, it quickly became a potentially harmful substance that can cause long-term health complications.
Here’s some information about the medication:
1. It Was Sold As An Over-The-Counter Medication
Ranitidine products under the brand Zantac were initially sold to consumers as a histamine-2 blocker. It’s an over-the-counter drug for heartburn and ulcers. It works by preventing the stomach from producing too much acid which causes problems in the digestive system. Additionally, the medication also helps treat and manage other conditions like gastroesophageal reflux disease (GERD) or Zollinger-Ellison syndrome. GERD is a chronic digestive disease that can cause various symptoms like dry cough, frequent heartburn, and pain in the neck and jaw. On the other hand, Zollinger-Ellison syndrome is a more serious medical condition where tumors may form in the pancreas and duodenum (upper part of the small intestine).
People who often experience discomfort in their gastrointestinal tract and digestive process take the medicine to keep their stomach acid under control. They can easily purchase the drug in pharmacies and stores with or without a prescription from a physician.
2. Zantac May Cause Health Complications
Although the U.S Food and Drug Administration (FDA) initially approved the medicine’s safety, it was later ruled as unsafe for consumption. The N-nitrosodimethylamine (NDMA) content of the drug can become a combustible substance and cause health complications. When exposed to heat, volatile levels of NDMA may cause illnesses like liver cancer, gastrointestinal cancer, leukemia, and other life-threatening diseases.
NDMA is known to be a carcinogenic chemical that can be manufactured through industrial processes. It’s found in various sources like tobacco smoke, foods like smoked meat or cheese, pesticides, and detergents. Exposure to low levels of NDMA is considered non-life-threatening. However, if a person takes high doses of the chemical, they may eventually develop certain illnesses.
People who take the ranitidine regularly to manage their condition were at risk of developing cancer from Zantac. Additionally, the drug may also cause various side effects like vomiting, liver failure, stomach pain, and hepatitis.
3. Its Manufacturing Process May Have Been Unsafe
The manufacturing and delivery process of Zantac and other ranitidine products may have exposed the drug to high temperatures and affect its contents before it gets sold to consumers.
Some of the ulcer medications sold in the market are from Australia and India where temperatures can go as high as 139 degrees Fahrenheit. The environmental conditions during the manufacturing stage of the drug may have affected its composition and made it unsafe for consumption.
In addition, the medication gets transported in cargo containers where the temperature may not be stable. There are also no instructions indicated on the packaging stating that the drug must be kept in cold storage at all times.
This means that before a consumer gets their hands on Zantac, it could have already been exposed to various temperature changes. If they take it regularly to maintain their health concern, they may become more prone to developing cancer and other health complications. Many reliable sources like Drug Injury News released information regarding the medicine to keep the public updated and warned about the potential long-term effects of the drug.
4. The Drug Was Recalled
Valisure Laboratories examined the drug in October of 2019 to determine whether its contents were safe for consumption. They also investigated to see the changes in Zantac when exposed to various external conditions. Their findings indicated that the NDMA content of the drug is within normal levels. However, when exposed to elevated temperatures, it increases and may potentially become harmful to a person’s body.
In April 2020, the Food and Drug Administration (FDA) issued a request to pull out all ranitidine products from the market. People who purchased the drug for health maintenance reasons were also advised to stop taking the medicine since it may increase their chances of developing cancer and other health problems.
Those who take the medicine to help manage their health condition were also instructed to consult with a physician before stopping their drug intake. Some patients were given alternatives to ensure they won’t experience adverse effects from suddenly discontinuing their intake of ranitidine.
5. Patients Who Developed Cancer Filed Lawsuits
Patients who were prescribed the drug to manage their health condition eventually filed lawsuits and claimed that the drug caused various types of health problems including 12 forms of cancer. Some individuals sued Zantac manufacturers due to misinformation. They claimed that the people behind ranitidine knew its potential health risks but chose to withhold it from patients and proceeded to sell the medicine.
Sanofi and Boehringer Ingelheim are two of the manufacturers that received various lawsuits from patients who developed cancer. One of the cases was from Joseph Galimidi, a patient diagnosed with breast cancer. He has been using the drug to manage his heartburn and acid reflux for a long time before it was even declared unsafe. He claimed that Zantac was the cause of his illness and requested compensation.
Furthermore, class-action lawsuits against the manufacturers of Zantac and other ranitidine products were also filed in California’s Northern District in 2019. The individuals who submitted the case claimed that leaving out crucial data about the drug put their lives at risk. They wanted the manufacturers to pay compensation for moral damages, medical expenses, death, disability, and other adverse effects of the drug on their lives.
Final Thoughts
The initial formulation of Zantac made by Sanofi was recalled and no longer available. It caused various complications to many patients who simply wanted to treat their ulcer and manage their gastrointestinal condition. It led to long-term effects and changed the lives of many people.
