Jane S. Ricciuti, RPh, MS


April 05, 2004

In This Article

Osteoporosis Agents

(risedronate sodium) Tablets

Manufacturer: Procter & Gamble Pharmaceuticals

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 2/24/04)

Precautions: The labeling for Actonel (risedronate sodium) Tablets was revised to add the following section to the Pregnancy subsection of the Precautions section:

  • Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. The extent of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the total dose and duration of bisphosphonate use. Although there are no data on fetal risk in humans, bisphosphonates do cause fetal harm in animals, and animal data suggest that uptake of bisphosphonates into fetal bone is greater than into maternal bone. Therefore, there is a theoretical risk of fetal harm (eg, skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impacts of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous vs oral) on this risk have not been established.

Actonel (risedronate sodium) Tablet Letter

Actonel (risedronate sodium) Tablet