** FDA SAFETY AND ADVERSE EVENT WARNING**

IBUPROFEN AND ASPIRIN TAKEN TOGETHER

On September 8, 2006, the Food and Drug Administration issued a Safety Information and Adverse Event Report regarding the concomitant use of low-dose aspirin (for cardioprotective benefits) and ibuprofen.

The report indicates that 400 mg ibuprofen taken with immediate-release low-dose aspirin (81 mg) will interfere with the antiplatelet effect of aspirin. Other over-the-counter NSAIDs should be viewed as having potential to interfere with the antiplatelet effect of aspirin.

Recommendations include taking immediate release low-dose aspirin 30 minutes prior to taking ibuprofen. If ibuprofen is taken first, aspirin should not be taken for at least 8 hours after ingestion of ibuprofen. Other analgesics that do not interfere with the antiplatelet effect of aspirin should be considered in populations at high-risk for cardiovascular events.

Enteric-coated aspirin and concomitant use of ibuprofen is unclear. One study showed that 400 mg ibuprofen interfered with the antiplatelet effect of enteric-coated low-dose aspirin at 2, 7, and 12 hours after ingestion (Catella-Lawson, 2001).

For more information, please refer to the information listed on the Food and Drug Administration’s web site for a complete copy of the alert and cited references.

http://www.fda.gov/medwatch/safety/2006/safety06.htm#aspirin

Scope and Target Population:
This guideline addresses the initial management of dyspepsia and gastroesophageal reflux disease (GERD) in adult males and non-pregnant adult females with symptoms on greater than 25% of days over the past 4 weeks.

Clinical Highlights and Recommendations:

• Send patients with dyspepsia plus one of the following alarm features for urgent endoscopic evaluation. Suggested time frames for the urgency of endoscopy are provided in italics behind each of the alarm features listed.
  
  • Melena (within 1 day if ill)
    
  • Hematemesis (within 1 day if ill)
    
  • Persistent vomiting (7-10 days)
    
  • Anemia (7-10 days)
    
  • Weight loss greater than 5% (involuntary) (7-10 days)
    
  • Acute onset of total dysphagia (within 1 day)
  
  
• Patients 55 years of age and older with symptoms of uncomplicated dyspepsia should be evaluated with non-urgent upper endoscopy.
  
• Patients with dyspepsia, but no alarm features or reflux symptoms, should receive H. pylori testing and if positive, eradicative therapy.
  
• Stool antigen is the preferred test for H. pylori in uninvestigated dyspepsia.
  
• Patients with dyspepsia and negative testing results for H. pylori should be treated empirically with Proton Pump Inhibitors (PPIs).
  
• Patients age 50 or older and who have had symptoms of GERD for 10 years or more should be considered for endoscopy during initial management.
  
• Patients with gastroesophageal reflux should receive single trial step-down therapy.
  
• Patients with GERD usually require long-term PPI therapy.
  
• Patients with GERD usually do not require H. pylori testing.

Priority Aims:

1. To increase the use of recommended methods for evaluating dyspepsia.
   
2. To increase appropriate pharmaceutical treatment of patients with dyspepsia.
   
3. To decrease complications associated with peptic ulcer disease.
   
4. To improve functional outcomes and satisfaction of patients with dyspepsia.
   
5. Increase the use of initial treatment recommendations for evaluating GERD.
   
6. To increase appropriate treatment for patients who have ongoing symptoms after initial treatment recommendations.
   

Additional Background
Dyspepsia is a common complaint in medical practice. A minority of these complaints are caused by gastric or duodenal ulcer. A very small minority of 1%-2% are caused by gastric cancer. Among those with duodenal ulcer a majority are caused by Helicobacter pylori infection of the stomach which contributes significantly to recurrent ulcer. With careful screening for alarm features, patients requiring urgent endoscopy can be identified. In addition, with testing and treatment for Helicobacter pylori, the burden of this infection can be reduced in the patient group.