Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015

News 13/04/2015

PRAC recommends updating advice on use of high‑dose ibuprofen

The PRAC has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day). No increase in cardiovascular risk is seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).

The PRAC recommended updating the advice in the product information of ibuprofen medicines. The recommendations for ibuprofen also apply to dexibuprofen, a medicine similar to ibuprofen. A high dose of dexibuprofen is a dose at or above 1,200 mg per day.

More information is included in the table below.

PRAC recommends further measures to minimise known risk of osteonecrosis of the jaw associated with zoledronic acid-containing medicines and denosumab

The PRAC has conducted three periodic reviews of denosumab (Prolia, Xgeva) and the bisphosphonate medicine zoledronic acid (Zometa, Zoledronic acid medac, and other nationally authorised medicines). Osteonecrosis of the jaw is a known risk for these medicines. The PRAC recommended measures, including updates to the product information and the introduction of patient reminder cards, to further minimise the known risks.

These reviews, known as a periodic safety update single assessment (PSUSA), are part of the regular safety monitoring of medicines. These recommendations follow a similar recommendation for another bisphosphonate medicine containing zoledronic acid (Aclasta) in March 2015. The PRAC will also consider similar measures for other intravenous bisphosphonates used for osteoporosis or for preventing bone complications of cancers. The measures will be considered during the upcoming and ongoing PDF iconperiodic reviews for these medicines, which are planned to take place over the course of 2015/2016.


PDF iconAgenda - PRAC draft agenda of meeting 7-10 April 2015

Recommendations by PRAC

Ibuprofen- and dexibuprofen-containing medicines

Article-31 referral: Ibuprofen- and dexibuprofen-containing medicines

PDF iconSummary of PRAC recommendation

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