Protelos and Osseor

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Summary

Protelos/Osseor to remain available but with further restrictions

The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis. In addition these patients should continue to be evaluated regularly by their doctor and treatment should be stopped if patients develop heart or circulatory problems, such as uncontrolled high blood pressure or angina. As recommended in a previous review, patients who have a history of certain heart or circulatory problems, such as stroke and heart attack, must not use the medicine.

These final recommendations from the Agency’s Committee for Medicinal Products for Human Use (CHMP) come after initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the medicine due to its cardiovascular risk.

'The CHMP agreed with the PRAC’s overall assessment of the risks of Protelos/Osseor. Both committees worked in close collaboration and the PRAC's recommendation was instrumental for us to fully assess the benefit-risk profile of the medicine', said Tomas Salmonson, chair of the CHMP. 'However, the CHMP considered that, for patients who have no alternative treatment, regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified by the PRAC so that these patients can continue to have access to the medicine.’

In arriving at its conclusions, the CHMP noted that study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture. In addition, available data do not show evidence of an increased cardiovascular risk with Protelos/Osseor in patients who did not have a history of heart or circulatory problems.

The CHMP considered that the cardiovascular risk in patients taking Protelos/Osseor can be managed by restricting its use to patients with no history of heart and circulatory problems and limiting its use to those who cannot take other medicines approved for the treatment of osteoporosis. In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.

Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine. Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures. The Committee concluded that given the benefits seen in preventing fractures in patients at high risk, Protelos/Osseor should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.

In deciding on how Protelos/Osseor should be used, the CHMP took into account the PRAC’s analysis of its benefits and risks as well as advice from osteoporosis experts that there is a group of patients who could benefit from the medicine.

'The PRAC has worked closely with the CHMP throughout the procedure and while we acknowledge that the recommendations of the two committees differed, our understanding of the medicine's benefit-risk profile is closely aligned and we share a common view of the importance of effective monitoring of cardiovascular risk', said June Raine, chair of the PRAC. 'The PRAC will continue to monitor the safety of Protelos /Osseor and the effectiveness of risk minimisation in long term use.'

The CHMP’s recommendations were sent to the European Commission, which endorsed them and issued a final legally binding decision valid throughout the EU.

Information to patients
  • Protelos/Osseor will only be prescribed for preventing fractures in post-menopausal women and men with severe osteoporosis who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
  • Before starting treatment, your doctor will assess your risk of heart disease and high blood pressure and continue to check your risk at regular intervals during treatment.
  • You should not take Protelos/Osseor if you have or have had heart or circulatory problems such as stroke, heart attack, or obstruction of the blood flow in the arteries.
  • Your treatment with Protelos/Osseor will be stopped if you develop heart or circulatory problems during treatment.
  • If you have any questions, speak to your doctor or pharmacist.
Information to healthcare professionals
  • Protelos/Osseor should only be used to treat severe osteoporosis in postmenopausal women and men at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance;
  • Protelos/Osseor must not be used in patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or those with uncontrolled hypertension;
  • Doctors should continue to base their decision to prescribe Protelos/Osseor on an assessment of the individual patient’s risks. The patient’s risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months;
  • Protelos/Osseor should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled;
  • Doctors should review their patients currently on Protelos/Osseor as necessary.

This final EMA recommendation on the use of Protelos/Osseor was based on an analysis of pooled data from randomised studies in around 7,500 post-menopausal women with osteoporosis. The results showed an increased risk of myocardial infarction with Protelos/Osseor as compared with placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI, 1.07 to 2.38), and an increased risk of venous thrombotic and embolic events — 1.9% versus 1.3 % with a relative risk of 1.5 (95% CI, 1.04 to 2.19).

Available data do not show evidence of an increased cardiovascular risk in patients without established, current or past history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or in those without uncontrolled hypertension.

Regarding the benefits, the efficacy data showed an effect in preventing fractures, including in patients at high risk of fracture.

More about the medicine

Protelos/Osseor (strontium ranelate) is authorised in the EU to treat severe osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and who are at high risk of fracture (broken bones) to reduce the risk of fractures of the spine and the hip. It is also used to treat severe osteoporosis in men who are at high risk of fracture.

The current recommendations add to EMA recommendations made in April 2013 not to use Protelos/Osseor in patients with known circulatory problems.

More about the procedure

The review of Protelos/Osseor was initiated in May 2013 at the request of European Commission under Article 20 of Regulation (EC) No 726/2004.

The first stage of this review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. The PRAC’s recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP) responsible for all questions concerning medicines for human use, which adopted the Agency’s final opinion.

Further information on the PRAC recommendation and the background to this review can be found on Agency’s website.

The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 15 April 2014.

Name Language First published Last updated
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions BG = bălgarski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions ES = español 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions CS = čeština 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions DA = dansk 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions DE = Deutsch 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions ET = eesti keel 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions EL = elliniká 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions EN = English 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions FR = français 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions IT = italiano 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions LV = latviešu valoda 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions LT = lietuvių kalba 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HU = magyar 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions MT = Malti 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions NL = Nederlands 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions PL = polski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions PT = português 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions RO = română 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions SK = slovenčina 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions SL = slovenščina 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions FI = suomi 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions SV = svenska 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  

Key facts

About this medicine

Approved nameProtelos and Osseor
International non-proprietary name (INN) or common name

strontium ranelate

Associated names
Class

About this procedure

Current statusEuropean Commission final decision
Reference numberEMEA/H/A20/1371/C/00560-561/0039-0034
TypeArticle 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of manufacturing or safety issues.

Decision making modelPRAC-CHMP-EC
Authorisation modelCentrally authorised product(s)

Key dates and outcomes

Procedure start date16/05/2013
PRAC recommendation date09/01/2014
CHMP opinion/CMDh position date20/02/2014
EC decision date15/04/2014
OutcomeVariation

All documents

Procedure started

Name Language First published Last updated
Protelos and Osseor Article-20 procedure: Review started HR = Hrvatski 2013-05-17  
Protelos and Osseor Article-20 procedure: Timetable for the procedure HR = Hrvatski 2013-05-17 2013-09-06
Protelos and Osseor Article-20 procedure: PRAC List of questions HR = Hrvatski 2013-05-17  
Protelos and Osseor Article-20 procedure: Notification HR = Hrvatski 2013-05-17  

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Name Language First published Last updated
PRAC recommends suspending use of Protelos/Osseor HR = Hrvatski 2014-01-10  

Opinion provided by Committee for Medicinal Products for Human Use

Name Language First published Last updated
Protelos and Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report HR = Hrvatski 2014-02-28  
Protelos and Osseor Article-20 procedure - Annex I, II and III HR = Hrvatski 2014-02-21  
European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions HR = Hrvatski 2014-02-21  

European Commission final decision

Name Language First published Last updated
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Annex IV HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Osseor Article-20 procedure - Product information HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  
Protelos and Osseor Article-20 procedure - Protelos/Osseor to remain available but with further restrictions HR = Hrvatski 2014-09-18  

Document description:

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

Current status:
European Commission final decision

More information on Protelos and Osseor