Label Changes for:

Vimovo (naproxen/esomeprazole magnesium) Tablets

November 2011

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2011

WARNINGS AND PRECAUTIONS

Bone Fracture
  • Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
  • Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.
  • Vimovo (a combination PPI/NSAID) is approved for use twice a day and does not allow for administration of a lower daily dose of the PPI.

ADVERSE REACTIONS

Postmarketing Experience
  • bone fracture 

 

 

June 2011

 

WARNINGS AND PRECAUTIONS

  • information regarding severe hepatic impairment, interactions with diagnostic investigations for neuroendocrine tumors, and concomitant use with St. John’s Wort or rifampin

DRUG INTERACTIONS

  • information regarding interactions with diagnostic investigations for neuroendocrine tumors, and concomitant use with cyclosporine, tacrolimus, anticoagulants, digoxin, and St. John’s Wort or rifampin

SPECIAL POPULATIONS

  • information regarding severe hepatic impairment

 

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