Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2015

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13/03/2015

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2015

PRAC recommends restrictions on the use of codeine for cough and cold in children

The PRAC has completed a review of codeine-containing medicines when used for cough and cold in children. It recommended a number of measures, including restricting the use of these medicines, to manage the risk of serious side effects including the risk of breathing problems.

This current review follows a previous review of codeine when used for pain relief in children. The recommended new restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.

More information is included in the table below.

PRAC recommends further measures to minimise known risk of osteonecrosis of the jaw associated with bisphosphonate medicine

The PRAC has conducted a periodic review, known as a periodic safety update single assessment (PSUSA), of one of the bisphosphonate medicines with a known risk of osteonecrosis of the jaw, Aclasta (zoledronic acid). The PRAC concluded that the risk of osteonecrosis of the jaw with this medicine remains very low but recommended measures, including updates to the product information and the introduction of a patient reminder card, to minimise this known risk.

The PRAC will consider similar measures for other intravenous bisphosphonates, used for osteoporosis or for preventing bone complications of cancers, as well as for denosumab, which is also associated with a risk of osteonecrosis of the jaw. The new measures will be considered during the upcoming and ongoing periodic reviews for these medicines, which are planned to take place over the course of 2015/2016.

More information is included in the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 9-12 March 2015

  

Recommendations by PRAC

Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

Article-31 referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

 

Summary of PRAC recommendation

 

Aclasta

Periodic safety update single assessment (PSUSA): Aclasta

 

Summary of PRAC recommendation

 

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Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu