UPDATE: (Jan. 2020) – Another testing lab, California-based Emery Pharma, has filed a Citizen’s Petition with the FDA urging the agency to recall all Ranitidine drugs. Emery’s petition follows the one filed last September by Valisure which also urged the FDA to recall all Ranitidine products.
“Manufacturers should have a strong warning on the label that if the product has been heated above a certain temperature, they shouldn’t use it,or else you may be exposing yourself to large quantities of this cancer-causing agent.”
-Ron Najafi Emery Pharma CEO
Read Emery Pharma’s Citizen Petition HERE.
Read Valisure’s Citizen Petition HERE.
Zantac (Ranitidine) belongs to a class of medications called H2-blockers. These popular medications are used for treating gastrointestinal conditions such as acid indigestion (‘heartburn’ and ‘sour stomach’) and gastroesophageal reflux disease (GERD) by decreasing the amount of acid produced by the stomach. Zantac was first approved for prescription use by the U.S. Food & Drug Administration in 1983, and in 1986 became the first drug to reach $1 billion in total sales. Zantac became available over-the-counter (“OTC”) (without a prescription) in 1996, and generic versions of Zantac began selling the following year. Despite prolific sales of generic Ranitidine, Zantac sales remain strong: in 2018, it was one of the top 10 antacid tablet brands in the U.S. with sales of almost $130 million.
In September of this year, it was discovered that when Zantac and other generic Ranitidine products metabolize in the body they produce dangerously high quantities NDMA (N-nitrosodimethylamine), a potent carcinogen. This came to light when Valisure, an online pharmacy, advised the FDA, filing a Citizen’s Petition, that its scientific testing of Zantac and generic Ranitidine revealed that each tablet contained NDMA at levels thousands of times higher than the FDA’s “permissible daily intake limit” (read more below). Notably, Valisure is not just a pharmacy, it operates an ISO (International Standards Organization) accredited laboratory. The FDA considers this accreditation “one of the most important standards for calibration and testing laboratories” and it gives strong credibility to Valisure’s test results.
“There’s no acceptable cancer risk for a drug like this.”
– David Light (Valisure CEO)
Valisure further wrote, “Since 2002, the formation of NDMA by the reaction of DMA and a nitroso source (such as nitrite) has been well characterized in the scientific literature.” In other words, peer-reviewed scientific studies of Ranitidine and NDMA suggest that drugmakers knew — or at a bare minimum should have known — that Zantac (Ranitidine) use exposes users to dangerously high amounts of NDMA.
The dangers NDMA pose to human health are long-standing and well known. It was once used to make rocket fuel and other petroleum-based industrial products. The FDA has established a “permissible daily intake limit for … NDMA of 96 [nanograms].” But according to Valisure, Zantac (Ranitidine) has an NDMA content of between 2.5-2.8 million nanograms per tablet.
Since the release of Valisure’s report virtually all generic and brand name versions of Zantac have been withdrawn from the consumer market, with most manufacturers voluntarily recalling their products.
Our firm is currently investigating cases where individuals took Zantac (or generic Ranitidine) before being diagnosed with one of the following types of cancer:
- Bladder Cancer
- Stomach Cancer (including gastric cancer)
- Colorectal Cancer (including colon and rectal cancer)
- Intestinal Cancer
- Esophageal Cancer
- Kidney Cancer
- Liver Cancer
- Pancreatic Cancer
- Uterine Cancer
If you or someone you know has been diagnosed with one of these forms of cancer after taking Zantac (or generic Ranitidine), contact us online or call us at 1-866-252-3535.
Do not stop taking any medication without consulting your healthcare provider.