Zantac Developments: Clinical Trials & Compounded Ranitidine:
The warnings first came from the U.S. Food and Drug Administration in September of 2019. Zantac, the popular heartburn medication prescribed more than 15 million times a year, might contain unacceptable levels of N-Nitrosodimethylamine or NDMA, a chemical that can cause cancer in humans. GlaxoSmithKline introduced ranitidine, and its brand name Zantac, to the United States in 1981. By 1987, Zantac was one of the most widely prescribed drugs in the U.S.In April of 2020, after further investigation, the FDA asked manufacturers and retailers to pull all prescription and over-the-counter ranitidine and Zantac off of the shelves. The FDA found NDMA "contaminating" ranitidine and declared that NDMA levels could increase over time and at higher than average temperatures. As a result, the FDA asked that anyone taking the medication stop immediately. While it is good news that the FDA acted to protect consumers' safety, it is concerning that such a popular medication made it to market.
Zantac Clinical Trials
Before GlaxoSmithKline could sell Zantac and ranitidine in the U.S., the drug had to undergo rigorous testing and evaluation by the FDA's Center for Drug Evaluation and Research. The center is supposed to ensure that drugs work correctly and that their benefits outweigh any risks.Ranitidine underwent rigorous clinical testing before the FDA approved its use in the U.S. However, the problem with ranitidine isn't necessarily a problem with manufacturing; it's a problem with how the drug degrades over time and in real-life situations. NDMA isn't necessarily "contaminating" Zantac. It's not an impurity introduced during manufacturing. Instead, ranitidine seems to degrade over time, providing the necessary components for NDMA. The fact that Zantac made it to market, despite degrading into a carcinogen, may reveal a fundamental problem with the way we test and approve medications in the United States.
Injuries from Compounded Ranitidine
Sometimes patients can't take a brand name or generic form of a drug if a patient is too young to swallow capsules or if the medication contains an allergen the patient can't have. Sometimes a medical provider wants to combine two medications into one. In these cases, pharmacies or hospitals compound medications for patients. The FDA does not approve compounded medications and can't guarantee its efficacy or safety.After manufacturers pulled ranitidine from shelves, some compounding pharmacies continued to compound the medication themselves, claiming that this would avoid NDMA "contamination." However, as it becomes clear that NDMA isn't a contaminate but results from the degradation of ranitidine, compounded medications are not any safer than those sold on pharmacy shelves.
Cancers caused by NDMA
NDMA is a probable human carcinogen. People who have consumed Zantac or other drugs that break down into NDMA or contain NDMA contaminants may be at a higher risk for certain chronic conditions. Even small amounts of NDMA can cause severe liver damage. Other conditions include:• Stomach cancer• Cancer of small and large intestines• Colorectal cancer• Esophageal cancer• Kidney cancer• Bladder cancer• Liver cancer• Prostate cancer• Pancreatic cancer• Leukemia• Non-Hodgkin’s lymphoma• Multiple myelomaIf you believe that Zantac or compounded ranitidine has harmed you or someone you love, contact the Madeksho Law Firm at 888-910-6376, or through our online form. Your initial consultation is free, and you never pay a fee unless we recover compensation on your behalf.
