Pharmacy Daily | EMA to restrict Protos

Servier Laboratories has confirmed it will work with the Therapeutic Goods Administration on its review of Protos (strontium ranelate), following a decision by the European Medicines Agency to further restrict the use of the osteoporosis medication. The EMA has now concluded its review of Protos, and has recommended its use only in patients who cannot be treated with other medicines approved for osteoporosis, within the current contraindication of a history of heart or circulatory problems. However the EMA added that, given the benefits seen in preventing fractures in patients at high fracture risk, Protos should remain an option for patients with no history of cardiovascular disease. Servier says it’s acting immediately to provide the TGA with all information relating to the EMA’s decision to change the prescribing indication of the osteoporosis medicine. The TGA launched its review of Protos earlier this month (PD 05 Feb) when an EMA committee recommended its suspension.

---

The above article was sent to subscribers in Pharmacy Daily's issue from 25 Feb 14
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 25 Feb 14