Risedronic acid

Risedronic acid, often used as its sodium salt risedronate sodium, is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone.

Risedronic acid
Clinical data
Trade namesActonel, Atelvia, Benet, others
AHFS/Drugs.comMonograph
Pregnancy
category
  • AU: B3
  • US: C (Risk not ruled out)
    Routes of
    administration
    Oral
    ATC code
    Legal status
    Legal status
    • UK: POM (Prescription only)
    • US: ℞-only
    • In general: ℞ (Prescription only)
    Pharmacokinetic data
    Bioavailability0.63%
    Protein binding~24%
    MetabolismNone
    Elimination half-life1.5 h
    ExcretionRenal and fecal
    Identifiers
    CAS Number
    PubChem CID
    IUPHAR/BPS
    DrugBank
    ChemSpider
    UNII
    ChEMBL
    PDB ligand
    CompTox Dashboard (EPA)
    ECHA InfoCard100.116.436
    Chemical and physical data
    FormulaC7H11NO7P2
    Molar mass283.112 g·mol−1
    3D model (JSmol)
     NY (what is this?)  (verify)

    It was patented in 1984 and approved for medical use in 1998.[1]

    Pharmacology

    Relative potency[2]
    Bisphosphonate Relative potency
    Etidronate 1
    Tiludronate 10
    Pamidronate 100
    Alendronate 100-500
    Ibandronate 500-1000
    Risedronate 1000
    Zoledronate 5000

    Brand names

    It is produced and marketed by Warner Chilcott, Sanofi-Aventis, and in Japan by Takeda under the trade names Actonel, Atelvia, and Benet. It is also available in a preparation that includes a calcium carbonate supplement, as Actonel with Calcium.

    Controversies

    In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva.[3] The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on September 7, 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".[4]

    In 2006, P&G faced controversy over its handling of clinical research involving risedronate (News Reports[5] and discussion).[6]

    In common with other bisphosphonate drugs, risedronate appears to be associated with the rare side effect osteonecrosis of the jaw, often preceded by dental procedures inducing trauma to the bone.

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    See also

    References

    1. Fischer, Jnos; Ganellin, C. Robin (2006). Analogue-based Drug Discovery. John Wiley & Sons. p. 523. ISBN 9783527607495.
    2. D., Tripathi, K. (30 September 2013). Essentials of medical pharmacology (Seventh ed.). New Delhi. ISBN 9789350259375. OCLC 868299888.
    3. "P&G Press statement". Uk.pg.com. Retrieved 2013-03-01.
    4. NY fed judge finds promotions for bone drug Boniva are fair Associated Press, 7 Sept 2006
    5. http://www.thejabberwock.org/wiki/index.php?title=Actonel_Case_Media_Reports
    6. "Scientific Misconduct Blog". Scientific-misconduct.blogspot.com. Retrieved 2013-03-01.
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