What does the FDA (US Food and Drug Administration) say about PPI use

Proton pump inhibitors (PPIs), is a group of medications that reduce stomach acid and are used to treat various gastrointestinal conditions. It is one of the most sold drug category in the world. It helps many people, and at the same time is often overused in longterm application. The US FDA (Food and Drug Administration) is a US government agency, that as one of it´s duties regulates the application of regulated drugs.

On the use of proton pump inhibitors (PPIs) the FDA provides specific guidance. Here are the key points regarding PPI use according to the FDA:

Approved Indications

PPIs are approved for several conditions, including:

– Healing of erosive esophagitis (EE)
– Maintenance of healed EE
– Treatment of gastroesophageal reflux disease (GERD)
– Risk reduction for gastric ulcers associated with nonsteroidal anti-inflammatory drugs (NSAIDs)
– Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence, often in combination with antibiotics[2][4].

## Recommendations for Use

The FDA advises that PPIs should be used at the lowest effective dose for the shortest duration necessary. This is particularly important due to potential risks associated with long-term use, such as:

– Low magnesium levels (hypomagnesemia), which can occur with prolonged PPI therapy (typically longer than one year) and may lead to serious health issues[4].
– Other adverse reactions may include headache, diarrhea, nausea, and abdominal pain. Long-term use has also been linked to increased risks of fractures and Clostridium difficile infections[2][4].

Safety and Monitoring

Patients are encouraged to seek medical attention if they experience severe side effects or if they need to use PPIs for extended periods. The FDA has highlighted the importance of monitoring patients on long-term PPI therapy for potential complications, including the aforementioned hypomagnesemia and other adverse effects[2][4].

In summary, while PPIs are effective for managing certain gastrointestinal conditions, the FDA emphasizes cautious use, particularly regarding dosage and duration, to minimize risks associated with long-term therapy.

Citations:
[1] https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources
[2] https://www.cms.gov/medicare-medicaid-coordination/fraud-prevention/medicaid-integrity-education/pharmacy-education-materials/downloads/ppi-adult-factsheet11-14.pdf
[3] https://www.fda.gov/about-fda/division-patient-centered-development/patient-preference-information-ppi-medical-device-decision-making
[4] https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-low-magnesium-levels-can-be-associated-long-term-use-proton-pump
[5] https://www.ncbi.nlm.nih.gov/books/NBK557385/
[6] https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-clostridium-difficile-associated-diarrhea-can-be-associated-stomach
[7] https://www.hca.wa.gov/assets/billers-and-providers/ProtonPumpInhibitorNotice.pdf
[8] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020987s058,022020s021lbl.pdf

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