Protaxos® (strontium ranelate): New restricted indication and contraindications for use

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Date: 13 August 2014

Description: This issue was highlighted in a previous NPCB Safety Alert issued on 27 January 2014. Following completion of NPCB’s benefit-risk profile review related to cardiovascular risk, the indications of Protaxos® have been tightened, and it is contraindicated in patients with established, current or past history of ischaemic heart disease, peripheral artery disease, or those with uncontrolled hypertension. Prescribers are advised to assess and monitor patient’s cardiovascular risk before and during treatment. A Direct Healthcare Professional Communication (DHPC) regarding this issue, along with a Prescriber Checklist, has been approved by NPCB and released by Servier Malaysia Sdn. Bhd.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

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