The US Food and Drug Administration (FDA) has withdrawn Zantac and other over-the-counter brands of ranitidine drugs because tests have shown they include the carcinogenic impurity nitrosodimethylamine (NDMA). As a result, The nationwide recall of the popular heartburn medicine Zantac has steadily expanded since it was first issued in April.
The FDA is advising consumers of over-the-counter ranitidine to stop taking the medication and dispose of any unused ranitidine medications they have at home. Patients taking prescription ranitidine medications should consult with their doctors before stopping the medication and pursuing other treatments. There are other FDA-approved medications available to treat heartburn that do not carry the same risks from NDMA.
Safe Zantac Alternatives
The FDA advises doctors and anyone taking Zantac or generic ranitidine to consider Zantac alternatives. Currently, the FDA has confirmed the following heartburn medications to be free of NDMA and suggest them as Zantac substitutes:
- Nexium (esomeprazole)
- Prevacid (lansoprazole)
- Prilosec (omeprazole)
- Pepcid (famotidine)
- Tagamet (cimetidine)
Medications for heartburn and other stomach acid conditions are classified as two types: H2 blockers and proton pump inhibitors (PPIs). Each type works differently in the body to relieve symptoms. When seeking a Zantac alternative, always consult with a doctor before stopping, starting or switching medications.
H2 blockers are antihistamines that prevent inflammatory stimulation in the stomach. Histamine stimulates the stomach lining to produce hydrochloric acid, the main component of stomach acid. H2 blockers specifically decrease acid production in the evening when secretion is at its worst.
Of the list above, Tagamet and Pepcid are H2 blockers. Zantac was also an H2 blocker. H2 blockers are effective for most cases of heartburn that do not respond to lifestyle changes. However, it’s important to note that H2 blockers are for short-term use. Eventually, the stomach adjusts to the drug and there is a significant decrease in effectiveness. The potential side effects of H2 blockers are typically mild, but may include:
- Headaches and muscle aches
- Abdominal pain
Persistent reflux or reflux that occurs twice or more per week could be indicative of GERD (gastroesophageal reflux disease). In that case, a doctor would probably prescribe a stronger treatment in the form of a PPI.
Proton Pump Inhibitors (PPIs)
PPIs are recommended or prescribed when H2 blockers are not effective enough. Nexium, Prevacid and Prilosec are PPIs. They are used to treat the more serious gastric acid-related conditions such as GERD and esophagitis (inflammation of the esophagus).
Proton pumps are the enzymes in the stomach responsible for forming hydrochloric acid. PPIs work by decreasing the amount of acid proton pumps produce. They are considered stronger and faster in reducing stomach acid than H2 blockers. They have similar common side effects as H2 blockers. However, the FDA has issued several warnings related to the side effects of PPIs, as those can be more severe than H2 side effects.
Possible side effects after long-term use of PPIs may include:
- Increased risk of fractures
- Hypomagnesemia—low level of magnesium that can result in convulsions, muscle weakness and fatigue
- Vitamin B12 deficiency
- Increased risk of pneumonia
- Increased risk of dementia
- Skin Lesions
While nearly all the effects were seen in long-term users, studies have yet to establish a direct link between PPIs and the side effects. However, it is critical for any consumer to consult with a healthcare provider to determine if it is worth the risks to stay medicated for more than a few weeks.
Alternative Non-Medicinal Treatments
Doctors will usually recommend certain lifestyle treatments to ease symptoms of peptic ulcers or GERD. For instance, a doctor may recommend someone with ulcers limits the use of aspirin and ibuprofen. Both drugs are proven to increase the risk for peptic ulcer disease.
Note that no one should ever discontinue their medications before speaking to a doctor first.
Non-medicinal heartburn, GERD and ulcer treatments may include lifestyle changes such as:
- Eating several small meals per day instead of three large meals
- Avoiding spicy food/drinks, alcohol, and tobacco
- Elevating part of the bed to raise the head about six inches
- Consuming less fat
- Avoiding lying down until at least two hours after eating
- Avoiding eating too soon before sleeping
H2 blockers and PPIs aren’t prescribed together and should not be taken at the same time. Finding a safe alternative to Zantac will include consulting with a doctor to decide on alternative treatments.
How Many People Does the Ranitidine Recall Affect?
The American College of Gastroenterology reports that more than 60 million Americans suffer from heartburn at least once a month. Other studies have determined that more than 15 million Americans experience heartburn symptoms each day.
Zantac is a type of antihistamine that decreases stomach acid production. Prior to the recall, Zantac was approved as heartburn medicine for adults and children over 12 years old. Other conditions that were treated with Zantac include:
- Gastric ulcers
- Small intestine ulcers
- Excess production of stomach acid
- Gastroesophageal reflux disease (GERD)
Symptoms of heartburn are more common among the elderly and pregnant women. It is imperative for anyone who relies on heartburn medication to make changes as a reaction to the recall with knowledge of safe Zantac alternatives.
Detecting NDMA in Pharmaceuticals
When the FDA first discovered trace amounts of NDMA in ranitidine in September 2019, the levels were too low to be considered harmful to human health. The levels of exposure were comparable to eating “common foods like grilled or smoked meats. The consensus was that the benefits of using ranitidine medications outweighed the risks.
However, the FDA continued its investigation and it has since been determined that NDMA levels in ranitidine drugs can rise to unhealthy levels if taken long enough, even under normal storage conditions. Additionally, levels of NDMA in ranitidine drugs significantly increase the longer ranitidine is stored and when stored at higher than room temperatures.
The FDA claims the permissible daily intake of NDMA is 96 nanograms. An independent study conducted by the online pharmacy Valisure detected extremely high levels of NDMA across multiple manufacturers and dosage forms of ranitidine. Valisure adjusted their testing methods to replicate the digestive conditions inside a human stomach, different than the FDA’s testing method. Valisure found quantities of NDMA of about 300,000 nanograms per tablet, more than 3,000 times higher than the FDA’s limit.
Products Linked to NDMA Exposure
- Zantac 75 Tablets
- Maximum Strength Zantac 150 Tablets
- Maximum Strength Zantac 150 Cool Mint Tablets
- Nizatidine Oral Solution (brand name Axid)
Health Effects of NDMA
Researchers have meticulously documented NDMA’s cause of cancer in animals. Though it has not been as thoroughly studied in humans, the U.S. Environmental Protection Agency (EPA) and The International Agency for Research on Cancer (IARC) have classified it as a probable human carcinogen. (Carcinogens are substances or materials known to cause cancer.)
Cancers linked to NDMA exposure include:
- Liver cancer
- Bladder cancer
- Gastric (stomach) cancer
- Esophageal cancer
- Colorectal cancer
- Uterine cancer
- Kidney cancer
- Pancreatic Cancer
The risk of cancer depends on factors related to an individual’s use of Zantac, including:
- The level of NDMA in the ranitidine products used
- The length of time he or she used the product containing NDMA
- Individual health conditions
Manufacturers of ranitidine were informed of the NDMA detected in their product before the recall. This fact is particularly unsettling knowing that they failed to adequately warn consumers of the risk.
Zantac is manufactured by the company Sanofi. The first class action lawsuit against Sanofi was filed in September 2019, and since then additional class action lawsuits have been filed in New Jersey, New York and Connecticut. There have not yet been any Zantac settlements currently.
Eligibility factors for a Zantac lawsuit:
- History of Zantac use—Individuals may qualify if they are able to prove they took Zantac. Proof could be in the form of a prescription, doctor’s note, or receipt
- Cancer diagnosis—Individuals should be able to prove their diagnosis with ample medical records and documentation of health conditions
- Proof of using Zantac at a high dose or for an extended period of time would help connect the drug to the cancer diagnosis
- A Zantac lawsuit may provide compensation for:
- Present and future medical expenses
- Loss of income and loss of future income
- Permanent disability
- Pain and suffering and other emotional damages
- Wrongful death
Get Help from a Zantac Lawsuit Attorney
If you or a loved one are suffering from the side effects of NDMA exposure after taking Zantac or ranitidine, it’s in your best interest to speak with a legal expert to determine your eligibility. The attorneys at Sobo & Sobo have decades of experience with defective drug lawsuits.
Call 845-468-7626 or contact online to schedule a free consultation.