Prescribing Advice for GPs

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New contraindications for strontium ranelate

The European Medicines Agency (EMA) has completed a review of strontium ranelate (Protelos®). A positive benefit-risk balance has been confirmed but new contraindications and revised warnings have been recommended.

The review was initiated by a French study that identified almost 200 adverse drug reports. Approximately half of these were reports of venous thromboembolism (VTE) and about a quarter were skin reactions. These are both known reactions; VTE was identified during clinical trials and skin reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) identified during post-marketing surveillance.

The review identified that VTE risk is highest in individuals with a personal history of VTE or who are temporarily or permanently immobilised. Skin reactions are best managed by early diagnosis and immediate discontinuation of any suspect drug.

The EMA has made the following recommendations:

  • Strontium ranelate should not be prescribed to patients with current VTE or a history of VTE, as well as patients who are temporarily or permanently immobilised.
  • Current treatment with strontium ranelate in such patients should be reviewed at the next routine appointment.
  • Patients should be warned about the potential for serious skin reactions. SJS and TEN usually occur in the first weeks of treatment while DRESS more usually occurs between 3 and 6 weeks.
  • Patients should be advised to stop treatment immediately if severe allergic reactions arise (including skin reactions) and treatment should never be recommenced

Action: Clinicians should be aware of this review and implement any changes to practice made necessary by these new recommendations.

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5 Comments to “New contraindications for strontium ranelate”

  1. How can anyone take these.
    To me the cure is as bad if not worse than the illness?

    Comment by JJ MACKAY — October 24, 2012 #
    Reply

  2. I have been taking Protos since March 2012 and have suffered from very loose stools and bladder problems. I have tried to take half doses in an attempt to accustomise my body to no avail. I had previously been on Fosamax for a number of years and developed an adenoma in my caecum resulting is two life-threatening operations. My doctor said I had developed bone toxicity and was also diagnosed with inflamation of the stomach lining. Any suggestions as to how to prevent further bone loss. I am 76 and have had a fracture of the spine and a wrist bone.

    Comment by P.B. Myhill — September 10, 2012 #
    Reply

    1. @P.B. Myhill,

      You haven't revealed your gender so I'm not sure if raloxifene would be suitable for you (it's only licensed in women as it works on oestrogen receptors) or there is an injection called teriparatide that can be used in extremely severe cases of osteoporosis. It's worth discussing the remaining options with your doctor.

      Comment by Matthew Robinson — September 10, 2012 #
      Reply

  3. [...] drug safety section also draws attention to the new contraindications for strontium relating to venous thromboembolism (VTE) and serious skin [...]

    Pingback by Prescribing Advice For GPs » Drug Safety Update – May 2012 — May 22, 2012 #
    Reply

  4. Osteoporosis : avoid strontium ranelate (Protelos°)
    Strontium ranelate should be avoided as a treatment for osteoporosis due to its disproportionate adverse effects.

    The efficacy of strontium ranelate (Protelos°), prescribed to prevent osteoporosis-related fractures, is at best limited, and it offers no advantage over alendronic acid, a standard bisphosphonate. Its adverse effects are disproportionate: deep vein thrombosis and pulmonary embolism; sometimes fatal hypersensitivity, starting with a rash; muscle damage; confusion and hallucinations; etc.

    In September 2011, the French health authority placed restrictions on the reimbursement of Protelos°, a drug commercialised as a treatment for osteoporosis in post-menopausal women. It is now reimbursed only when a bisphosphonate treatment has failed or been ruled out, or for patients not at risk from deep vein thrombosis. And from 1st January 2012, the reimbursement rate for Protelos° by France's national health insurance system dropped from 65% to 30%.

    The French health products safety agency (Afssaps) has recommended “restricting the use of this drug to patients aged under 80 who have a contra-indication or an intolerance of bisphosphonates and a high risk of fractures”, and to inform patients that they must stop taking the drug immediately if they develop a skin rash.

    In practice, when a bisphosphonate cannot be used, raloxifene, an oestrogen agonist/antagonist, is a second-line preventive option for recurrent fractures, but its many adverse effects must be taken into account.

    ©Prescrire 1 March 2012

    "Strontium ranelate: too many adverse effects (continued)" Prescrire Int 2012; 21 (125): 72.

    Comment by Christophe Kopp — March 30, 2012 #
    Reply

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