- Prescribing Advice for GPs - https://www.prescriber.org.uk -

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:

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