What are the risks of using Naproxen (Nonsteroidal Anti-Inflammatory Drug, NSAID) in a patient with a history of peptic ulcer disease?

From the Guidelines

Naproxen should be avoided in patients with a history of ulcers due to increased risk of recurrence and complications. If pain management is necessary, consider alternatives like acetaminophen, which doesn't irritate the stomach lining.

Key Considerations

• If an NSAID is absolutely required, it should be used at the lowest effective dose for the shortest duration possible, and always with a proton pump inhibitor (PPI) such as omeprazole 20mg daily for gastroprotection, as suggested by 1.
• Celecoxib (100-200mg daily) may be a safer NSAID option as it has lower gastrointestinal risk, though it still requires PPI co-therapy in high-risk patients, as noted in 1 and 1.
• The combination of a COX-2 inhibitor and a PPI is recommended to reduce the risk for recurrent bleeding from that of COX-2 inhibitors alone, according to 1 and 1.

Rationale

The reason for caution is that naproxen, like other traditional NSAIDs, inhibits prostaglandin production which protects the gastric mucosa, thereby reducing the stomach's natural defenses against acid.

Patient Risk

Patients with prior ulcers have approximately 2-4 times higher risk of developing another ulcer when taking NSAIDs compared to those without such history, as indicated by 1.

Monitoring

Regular monitoring for symptoms like abdominal pain, black stools, or vomiting is essential if any NSAID therapy is initiated.

Evidence-Based Recommendation

Based on the evidence from 1 and 1, the combination of a COX-2 inhibitor and a PPI is the recommended approach for patients with a history of ulcers who require NSAID therapy.

From the FDA Drug Label

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors Naproxen Use with Old History of Ulcer

• The patient has an increased risk of GI bleeding due to their old history of ulcer.
• Naproxen should be prescribed with extreme caution in this patient.
• The lowest effective dose should be used for the shortest possible duration to minimize the potential risk for an adverse GI event.
• Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy 2

From the Research

Naproxen and Old History of Ulcer

• Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that can increase the risk of gastrointestinal adverse effects, including peptic ulcer disease 3, 4, 5.
• Patients with a history of ulcers who are taking NSAIDs, such as naproxen, are at higher risk of ulcer recurrence and complications 4.
• Proton pump inhibitors (PPIs) are effective in preventing the development of gastric and duodenal ulcers in high-risk patients taking NSAIDs, including those with a history of ulcers 3, 5.
• In patients with a history of ulcers receiving NSAID therapy, PPIs with or without celecoxib are recommended for the prevention of ulcer recurrence 4.
• The use of PPIs, such as omeprazole, pantoprazole, and lansoprazole, has been shown to be effective in healing NSAID-induced ulcers and preventing their recurrence in patients requiring ongoing NSAID therapy 5.
• Misoprostol is also effective in reducing NSAID-induced mucosal damage, but patient compliance is limited by poor tolerance 3, 5.
• Histamine receptor antagonists are relatively effective against duodenal ulcers but offer no significant protection against gastric ulcers 5.