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15 avril 2011 : EuropeanMedicines Agency | 7 WestferryCircus | Canary Wharf | London E14 4HB | United Kingdom
EuropeanMedicines Agency concludes class review of bisphosphonates and atypical fractures

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The EuropeanMedicinesAgency'sCommittee for MedicinalProducts forHuman Use (CHMP) has concluded that rare atypical fractures of the femur are a class effect of bisphosphonates.

  • The CHMP confirmedthat the benefits of bisphosphonates in the treatment and prevention of bonedisorders continue to outweightheirrisks, but that a warning of the risk of atypicalfemoral fractures shouldbeadded to the prescribing information for all bisphosphonate-containingmedicines in the European Union. Such a warning hadalready been included in the product information for alendronate-containingmedicinesacross Europe, following a review by the CHMP's Pharmacovigilance Working Party in 2008. It willnowbeextended to the wholebisphosphonate class.
  • Prescribers of bisphosphonate-containingmedicinesshouldbeawarethatatypical fractures of the femurmayoccurrarely. If an atypical fracture issuspected in one leg, then the otherlegshouldalsobeexamined. Doctorswho are prescribingthesemedicines for osteoporosisshouldregularlyreview the need for continuedtreatment, especiallyafter five or more years of use.
  • Patients who are takingbisphosphonate-containingmedicinesneed to beaware of the risk of thisunusual fracture of the femur. Theyshould contact theirdoctor if they have any pain, weakness or discomfort in the thigh, hip or groin, as thismaybe an indication of a possible fracture.
  • The marketing authorisationholders of bisphosphonate-containingmedicines have been asked to closely monitor thisissue.Thecomplete questions and answers document referring to thismattercanbefound in the followinglink:

http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Bisphosphonates_31/WC500105287.pdf

The press release document referring to thismattercanbefound in the followinglink:

http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/04/WC500105281.pdf

Please, findalsoattached a key messages document on bisphosphonates and atypicalfemoral fractures.

With Kind Regards,

Alessandro Camera | Medical Information Sector
EuropeanMedicines Agency | 7 WestferryCircus | Canary Wharf | London E14 4HB | United KingdomTel. +44 (0)20 7418 8724 | Fax +44 (0)20 7523 7129 | Cette adresse email est protégée contre les robots des spammeurs, vous devez activer Javascript pour la voir. | www.ema.europa.eu<http://www.ema.europa.eu>

Bisphosphonates and atypical femoral fracture - Key Messages for communication to healthcare professionals

The following key messages identified from this review should be communicated to health care professionals, patients and patients' organisations:

  • Atypical femoral fractures (please see definition in Annexe 1) have been reported rarely with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis.
  • They can occur after minimal or no trauma. Some patients experience thigh or groin pain, often associated with features of stress fractures on x-ray, weeks to months before presenting with a completed femoral fracture.Poor healing of these fractures has been reported.
  • An atypical femoral fracture is considered a class effect of bisphosphonates and a warning about this risk will be added to the product information for all bisphosphonates.
  • The overall balance of risks and benefits of individual bisphosphonates in their authorised indications remain favourable

Advice to healthcare professionals

  • Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.
  • During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain. Any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
  • The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of bisphosphonate therapy on an individual patient basis, particularly after 5 or more years of use
  • Please report any cases of atypical femoral fractures or atypical fractures at other sites to the National Competent Authority in your country.

Annexe 1

CHMP adopteddefinition of atypicalfemoral fracture basedon the ASBMR definition of AtypicalFemoral Fracture: Major and MinorFeaturesa (Shane et al, 2010)

Major featuresb

  • Locatedanywherealong the femurfromjust distal to the lesser trochanter to just proximal to the supracondylarflare
  • Associatedwith no trauma or minimal trauma, as in afallfrom a standing height or less
  • Transverse or short oblique configuration
  • Complete fractures extendthroughbothcortices and maybeassociatedwith a medialspike; incomplete fractures involveonly the lateral cortex.

Minorfeatures

  • Noncomminuted
  • Localizedperiostealreaction of the lateralcortexc
  • Generalizedincrease in cortical thickness of the diaphysis
  • Prodromalsymptomssuch as dull or aching pain in the groin or thigh
  • Bilateral fractures and symptoms
  • Delayedhealing
  • Comorbid conditions (eg, vitamin D deficiency, rheumatoidarthritis, hypophosphatasia)
  • Use of pharmaceutical agents (eg, bisphosphonates, glucocortoids, proton pumpinhibitors)

aSpecificallyexcluded are fractures of the femoral neck, intertrochanteric fractures with spiral subtrochanteric extension, pathologic fractures associatedwithprimary or metastaticbonetumors, and periprosthetic fractures.

bAll major features are required to satisfy the case definition of atypicalfemoral fracture. None of the minorfeatures are required but sometimes have been associatedwiththese fractures.

cOftenreferred to in the literature as beaking or flaring.

 

 
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