Omeprazole is a common medication used to treat heartburn, acid reflux, and gastritis. It works by decreasing the amount of acid made in the stomach. Omeprazole is sold over-the-counter as Prilosec and is also available by prescription. While omeprazole is generally considered safe for short-term use, there are some concerns with taking it for extended periods.
How Omeprazole Works
Omeprazole belongs to a class of medications called proton pump inhibitors (PPIs). It works by blocking an enzyme called H+/K+ ATPase pump in the parietal cells of the stomach. This enzyme is responsible for the final step of acid production. By inhibiting this enzyme, omeprazole reduces the amount of acid released into the stomach.
The reduction of stomach acid from omeprazole helps relieve symptoms like heartburn, indigestion, and stomach pain. It also allows damaged tissues in the esophagus, stomach, and duodenum to heal. Omeprazole starts working within hours of taking the first dose and its effects can last up to 72 hours.
Approved Uses for Omeprazole
Omeprazole was originally approved by the FDA in 1989. It is approved for the following uses:
- Treatment of heartburn and symptoms of gastroesophageal reflux disease (GERD)
- Healing of erosive esophagitis
- Maintenance of healing of erosive esophagitis
- Treatment of stomach and duodenal ulcers
- Helicobacter pylori eradication (in combination with antibiotics)
- Treatment of Zollinger-Ellison Syndrome
- Treatment of pathological hypersecretory conditions
The standard prescription dose of omeprazole is 20 mg once daily before a meal. For over-the-counter use, the dose is 20 mg once daily for 14 days. Some prescription versions are available at higher strengths of 40 mg or 60 mg for more severe conditions.
How Long is Omeprazole Safe for?
For short-term treatment of heartburn, indigestion or mild GERD, omeprazole is considered safe for 4-8 weeks. For more severe erosive esophagitis and stomach/duodenal ulcers, up to 12 weeks of omeprazole may be needed. The FDA has also approved long-term daily use of omeprazole for maintenance of healing of erosive esophagitis.
However, some medical organizations recommend limiting PPI use to the shortest duration possible. This is based on concerns with potential side effects and safety issues with long-term use.
FDA Recommendations for PPI Use
In 2010, the FDA mandated safety labeling changes for prescription PPIs. The label indicates PPIs should be used at the lowest effective dose and for the shortest duration suitable for the condition being treated. They recommend:
- Treatment of most conditions should not exceed 8 weeks
- Do not take for longer than 14 days unless directed by a physician
- Repeated 14-day treatment courses may be taken, but not more frequently than every 4 months
Despite these recommendations, it is not uncommon for people to use PPIs like omeprazole for much longer than 8 weeks. GERD and heartburn are often chronic, recurring conditions that may require long-term management.
Medical Guidelines on PPI Usage
Gastroenterology societies have provided guidelines for appropriate PPI use:
| Organization | Recommendation |
|---|---|
| American Gastroenterological Association | Use the shortest duration of PPI therapy (4 to 8 weeks in most cases) |
| American College of Gastroenterology | Limit PPI use to minimum effective dose and duration needed to treat the condition |
| Choosing Wisely Canada | Avoid long-term use of PPIs for gastric protection or for treating uncomplicated heartburn |
These guidelines generally recommend limiting continuous PPI use to a maximum of 8 weeks in most cases. However, some people do require maintenance therapy for chronic GERD or severe erosive esophagitis that has not healed after the initial treatment period.
Concerns with Long-Term Omeprazole Use
While short-term use of omeprazole is safe in most people, regular long-term use raises some potential concerns. Possible issues associated with taking omeprazole for extended periods include:
Nutrient Malabsorption
Stomach acid helps break down food and release nutrients for absorption. By decreasing acid levels, omeprazole could potentially impair absorption of key nutrients like vitamin B12, iron, calcium, and magnesium. Deficiencies in these nutrients can lead to problems like anemia, osteoporosis, and neurological issues.
Increased Infection Risk
Some research indicates that decreased stomach acid from PPIs may increase susceptibility to bacterial infections. The most serious concern is an increased risk of Clostridium difficile (C. diff) infection. Other studies show links to community-acquired pneumonia, Salmonella, Campylobacter, and small intestine bacterial overgrowth.
Kidney Disease
Several large studies have found an increased risk of chronic kidney disease with regular PPI use. It is believed that decreased acid levels may lead to kidney injury by interfering with the excretion of toxins. Patients with existing kidney impairment are most vulnerable.
Fracture Risk
By potentially interfering with calcium absorption, some research shows that omeprazole and other PPIs could increase the long-term risk of fractures. A meta-analysis found a 25% increased risk of hip fractures with PPI use longer than one year.
Heart Problems
Some observational studies indicate there may be a link between chronic PPI use and a higher risk of heart attacks, strokes, and cardiovascular death. However, other studies show mixed results. More research is needed to confirm these findings.
Dementia
A few studies have reported an association between regular PPI use and increased dementia risk later in life. This could potentially be related to impaired nutrient absorption. However, the evidence is still inconsistent at this time.
Drug Interactions
By reducing stomach acidity, omeprazole can alter absorption of other medications. There are potentially dangerous interactions with drugs like Plavix, methotrexate, digoxin, iron, and antifungals. Omeprazole may reduce the efficacy of these medications.
Rebound Acid Hypersecretion
A well-known effect of PPIs is rebound acid hypersecretion when stopping the medication suddenly after long-term use. This results in a surge of excess stomach acid. To prevent rebound, PPIs should always be tapered gradually over several weeks.
Who is Most at Risk?
While occasional short courses of omeprazole are low-risk, regular use for more than a year does raise safety concerns. Those most vulnerable to complications include:
- Older adults over 50 years old
- Individuals with existing vitamin B12 deficiency
- Patients with chronic kidney disease
- Individuals with osteoporosis or high fracture risk
- Those taking high-risk medications like Plavix, methotrexate, or digoxin
For high-risk groups, it is prudent to use omeprazole at the lowest effective dose and for the shortest duration possible. Careful monitoring and follow-up are also recommended.
Alternatives to Long-Term Omeprazole
For patients who need maintenance therapy for GERD or recurrent ulcers, there are some alternatives to long-term daily omeprazole that may be safer:
- Histamine (H2) blockers – Medications like ranitidine, famotidine, and cimetidine have less impact on nutrient absorption and kidney function compared to PPIs.
- Antacids – Products like Tums, Maalox, and Mylanta neutralize stomach acid as needed but do not block acid production entirely.
- Prokinetics – Medications like metoclopramide and domperidone help strengthen the lower esophageal sphincter and speed up stomach emptying.
- Intermittent PPI therapy – Taking omeprazole only when symptoms flare up rather than daily can help minimize risks.
- Surgery – For severe chronic GERD, surgical options like fundoplication can be done to repair the lower esophageal sphincter.
Non-drug treatments like diet/lifestyle changes, weight loss, smoking cessation, and avoiding trigger foods can also be beneficial.
Conclusion
In most cases, it is recommended to limit omeprazole use to 4 to 8 weeks for treating conditions like heartburn, indigestion, and mild GERD. For more severe erosive esophagitis or ulcers, up to 12 weeks may be warranted. While the FDA has approved maintenance use, there are potential safety concerns with taking omeprazole for more than one year continuously.
Long-term omeprazole use has been associated with risks like nutrient malabsorption, kidney disease, fractures, heart complications, and drug interactions. For patients requiring maintenance therapy, alternative medications or treatments may be safer options.
Those at highest risk for omeprazole complications include older adults, individuals with pre-existing medical conditions, and patients on high-risk drug regimens. Careful consideration of the benefits vs potential risks is important for long-term use of omeprazole.