Prescription and over-the-counter medicines can be equally dangerous when they are not properly tested before becoming available to consumers. Ranitidine hydrochloride, brand name Zantac, has been recalled due to high levels of N-Nitrosodimethylamine (NDMA), a human carcinogen that increases the consumer’s risk of cancer. The U.S. Food and Drug Administration (FDA) determined the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.
Because of Zantac’s popularity and widespread over-the-counter availability, the need for consumer awareness of the potential side effects is crucial to public health and safety. The first Zantac lawsuit was filed in California in 2019, accusing drugmakers Sanofi and Boerhringer Ingelheim of manufacturing, marketing, and selling a product they knew or should have known had been contaminated with an industrial chemical known to cause cancer. If a dangerous drug seriously harmed you or a loved one, do not delay contacting the dangerous drug attorneys at Dax F. Garza, P.C. for a free and confidential consultation.
What is Zantac?
Zantac is chemically known as ranitidine hydrochloride and belongs to a class of drugs called histamine H2-receptor antagonists (or H2 blockers), which decrease the amount of acid produced by the stomach. It is primarily used to prevent and treat heartburn. In more severe cases, Zantac can be prescribed to treat gastrointestinal and gastroesophageal issues, such as stomach ulcers and acid reflux disease. Zantac is a popular drug that consumers can purchase over the counter at local drug stores, as well as be prescribed higher levels of the drug to address more serious ailments.
Zantac related products include:
- Zantac 75mg
- Zantac Maximum Strength 150mg
- Zantac Maximum Strength 150mg Cool Mint Tablets
- Store-brand alternatives (Wal-Zan 150mg)
- Zantac 300mg (once daily)
Since the 1980s, numerous studies have demonstrated a link between the NDMA in Zantac and cancer. An ongoing investigation into the NDMA contaminant in ranitidine-based medications found the impurity levels in some ranitidine products increased over time and when stored at higher than room temperature. As a result, the human carcinogen NMDA could cause cancer in consumers. The FDA announced on April 1, 2020 that it was requesting manufacturers to withdraw all Zantac and generic Zantac OTC ranitidine drugs from the market effective immediately.
What is NDMA?
The found human carcinogen NDMA is a harmful contaminant that can lead to the development of cancer in consumers. NDMA is commonly used as a chemical in industrial lubricants as well as aviation fuel. The toxic chemical is also a byproduct of industrial plants responsible for high levels of pollution annually. This means NDMA is a known toxic chemical and should be handled with extreme caution.
NDMA is a serious chemical that the FDA, World Health Organization (WHO), and Environmental Protection Agency (EPA) have all deemed harmful, classifying it as a substance capable of causing cancer. Globally, the medical community has validated the severe dangerous of NDMA; therefore, it is beyond irresponsible for Zantac manufacturers to have ignored the preventable harm the product inflicted on unknowing consumers since its release in the 1980s. While the FDA accepted daily NDMA intake level is below 100 nanograms, it has been found that a 150mg dose of Zantac could include as more than 2.5 million nanograms, an astonishingly harmful amount of cancer-causing NDMA.
What Are the Dangers of NDMA?
Despite an initial FDA investigation of NDMA revealing carcinogen levels could increase under higher than normal room temperatures, the agency concluded it had insufficient data to support potential harm to consumers, which would result in a recall. It wasn’t until an independent lab conducted its own testing that additional FDA testing on the cancer-causing contaminant was undertaken. Upon further testing, the FDA found Zantac’s carcinogenic levels could actually increase in standard, normal room temperatures as well. This finding only further highlighted the dangerous effects the drug can inflict on vulnerable consumers.
Ranitidine products containing deadly doses of NDMA can cause cancer, in addition to numerous illnesses and long-term medical conditions that require ongoing treatment and care. Zantac side effects victims exposed to high levels of NDMA could suffer from any of the following symptoms:
- Abdominal cramping
- Arrhythmia or tachycardia
- Enlarged liver
- Hair loss
- Kidney failure
- Liver failure
- Lung failure
- Nervous system disorders
- Reduced blood platelet levels
- Skin rashes
- Vitamin B-12 deficiency
These symptoms can increase over time if a consumer is unaware of the dangerous side effects of prescription or over the counter drugs. By failing to follow FDA standards, as well as failing to properly inform consumers of a drug’s side effects and potential harms, consumers could unknowingly develop serious, life-threatening illnesses that are sadly avoidable.
Zantac Injury Lawyers
No consumer should develop cancer as a result of taking what they were led to believe was a harmless heartache medicine. Drug manufacturers have a duty to provide consumers with products that will not inflict additional injury or harm as well as the responsibility to inform consumers of what they are putting in their bodies by purchasing the product. If you or a loved one has been a victim of Zantac side effects, contact the Houston dangerous drug attorneys at Dax F. Garza, P.C. today for a free and confidential consultation.