Can you buy prilosec over the counter
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Can You Buy Prilosec Over the Counter?
Availability of Prilosec OTC
Prilosec, known generically as omeprazole, is available over the counter (OTC) in the United States. Since its introduction as an OTC drug in September 2003, Prilosec OTC has become a popular remedy for treating frequent heartburn1. The OTC version contains the same active ingredient as the prescription version, making it accessible for those who suffer from this condition.
FDA Advisory Panel Concerns
Despite its availability, there have been concerns regarding the OTC status of omeprazole. An advisory panel to the US Food and Drug Administration (FDA) once recommended against allowing omeprazole to be sold OTC. The panel's decision was based on uncertainties about whether patients would use the medication correctly without a doctor's supervision2. However, this recommendation did not prevent the eventual approval and widespread use of Prilosec OTC.
Consumer Adherence and Safety
Research has shown that consumers generally adhere well to the usage guidelines for Prilosec OTC. A study published in Clinical Gastroenterology and Hepatology found that a substantial majority of people who purchased OTC omeprazole followed the label instructions accurately. Over 90% of participants with frequent heartburn adhered to the one-pill-a-day guideline, and 96% used only one carton of 14 tablets or less within the recommended period1. This indicates that most users are capable of using the medication responsibly.
Effectiveness of Prilosec OTC
Studies have also demonstrated the effectiveness of Prilosec OTC in treating frequent heartburn. Research comparing Prilosec OTC to a placebo over a 14-day period found that omeprazole magnesium (Ome-Mg) in doses of 10.3 mg and 20.6 mg provided significant relief from heartburn symptoms3. This supports the use of Prilosec OTC as a viable option for those seeking relief from frequent heartburn.
Conclusion
In summary, Prilosec is available over the counter and has been since 2003. Despite initial concerns from an FDA advisory panel, research indicates that consumers generally use the medication correctly and find it effective for treating frequent heartburn. Therefore, Prilosec OTC remains a trusted and accessible option for managing this common condition.
Sources and full results
Most relevant research papers on this topic
FDA panel advises against omeprazole as over the counter drug
An FDA panel has advised against allowing omeprazole, the best selling treatment for chronic heartburn, to be sold over the counter due to concerns about patient safety and effectiveness.
Comparison of Prilosec OTCTM (omeprazole magnesium 20·6 mg) to placebo for 14 days in the treatment of frequent heartburn
Prilosec OTC (omeprazole magnesium 20-6 mg) is a safe and effective over-the-counter treatment for frequent heartburn when administered as a 14-day regimen.
RCTFDA panel advises against omeprazole as over the counter drug
Omeprazole, the best selling treatment for chronic heartburn, should not be allowed to be sold over the counter due to concerns about patient safety and potential drug interactions.
Now You See It. Now You Don't: Fair Balance and Adequate Provision in Advertisements for Drugs Before and After the Switch From Prescription to Over-the-Counter
Ads for over-the-counter drugs show less fair balance and inadequate provision than prescription ads, with less specific risk information and more benefits per 30 seconds in OTC ads.
Observational StudyHeartburn in Consumer-Directed Health Care and the Cost Outcomes of Therapeutic Maximum Allowable Cost
Each proton pump inhibitor (PPI) effectively relieves heartburn symptoms, but Prilosec OTC costs less than brand-name PPIs, making it a cost-effective treatment option for consumers.
Should oral contraceptive pills be available without a prescription? A systematic review of over-the-counter and pharmacy access availability
OTC availability of oral contraceptives may increase access and reduce unintended pregnancies, with patients and providers generally supporting this option.
Systematic Review
Rigorous JournalReview of the efficacy and safety of over-the-counter medicine
Over-the-counter medicines generally show favorable efficacy and safety evidence, but there are gaps in evidence for some therapy groups.
Systematic Review