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U.S. Department of Health and Human Services

Safety

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Actonel (risedronate sodium) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

 

Summary View

 

WARNINGS AND PRECAUTIONS

Jaw Osteonecrosis
  • Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Actonel...
  • For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ...
  • Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon...

USE IN SPECIFIC POPULATIONS

Pregnancy

  • There are no adequate and well-controlled studies of Actonel in pregnant women. Actonel should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
  • (all new information)
Pediatric Use
  • Actonel is not indicated for use in pediatric patients.
  • (all new information)
Renal Impairment
  • Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) because of lack of clinical experience.
Hepatic Impairment
  • No studies have been performed to assess risedronate’s safety or efficacy in patients with hepatic impairment...
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