16. March 2012 13:58
The European Medicines Agency (EMA) has recommended label changes to Servier’s osteoporosis drugs Protelos and Osseor to include new contraindications and revised warnings.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the drugs are an important treatment for women with osteoporosis, but that the associated risks need better management.
The CHMP no longer recommends Protelos and Osseor (strontium ranelate) for use in immobilised patients or patients with venous thromboembolism (VTE), and has recommended an update of the warnings regarding serious skin reactions.
Both drugs are indicated for the treatment of osteoporosis in postmenopausal women to reduce the risk of hip and spine fractures.
The review followed the publication of a French study that identified 199 severe adverse reactions to these medicines between January 2006 and March 2009. Around half were VTE events and around a quarter were skin reactions.
The risk of VTE was identified in clinical trials, and the risk of severe skin reactions had been reported from patient experience. These risks were already noted in the product information.
The CHMP has reviewed all available data on the safety of Protelos and Osseor and recommended:
• Doctors should not prescribe these drugs for patients with VTE or a history of VTE, or to patients who are immobilised. Patients in these categories should discuss their treatment with their doctor at their next scheduled appointment.
• Doctors should re-evaluate the need to continue treatment with Protelos or Osseor in patients over 80 years of age at risk of VTE.
• Prescribers should make patients aware of the time-to-onset and likely signs and symptoms of severe skin reactions. Patients should stop treatment immediately if such symptoms occur, and not resume at any time.
24. October 2011 10:36
A review has begun into the benefit-risk profile and the conditions of use of Servier’s Protelos (pictured) and Osseor following cases of venous thromboembolism (VTE) and drug rash with eosinophilia and systemic symptoms (DRESS).
The EMA is now analysing strontium-ranelate-containing osteoporosis medicines after links to cardiovascular and cutaneous events were found.
The CHMP says it is now reviewing all relevant data into the links before making a decision whether to change the benefit-risk balance of the medications.
Protelos and Osseor were authorised via the centralised procedure in September 2004 and are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
The EMA says that VTE and DRESS are known risks of these medicines and are addressed in the risk management plan and have been closely reviewed by the CHMP since their authorisation.
A study analysing the side effects associated with strontium-ranelate-containing medicines noted that there were 199 severe adverse reactions between January 2006 and March 2009. More than half of these (52%) were cardiovascular and more than a quarter (26%) were cutaneous.
The authors of the study concluded that DRESS is unpredictable but the VTE risk could be reduced by adding a contraindication for patients with a risk of cardiovascular risks and by stopping treatment if a new risk occurs.
Based on recent pharmacovigilance update and pending an European review, the French competent authority Afssaps have advised restricting the use of medication including strontium ranelate to patients who are under 80 years of age, at high risk of fractures and who cannot take bisphosphonates.