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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) March 2014


(Source: EMA 2014-3-11)

The European Medicines Agencys (EMA) Pharmacovigilance Risk Assessment Committee(PRAC) gave recommendations on three safety referrals at its March 2014 meeting.

PRAC recommends restricting use of domperidone

The PRAC has concluded an in-depth review of domperidone-containing medicines, carried out over concerns about the medicines effects on the heart. The Committee has recommended changes to their use throughout the European Union (EU), including using these medicines only to relieve symptoms of nausea and vomiting, restricting the dose and adjusting doses carefully by weight where it is licensed in children.

Summary of PRAC recommendation on Domperidone

Following re-examination, PRAC recommends diacerein remain available with restrictions

The PRAC has also recommended that diacerein-containing medicines remain available but with restrictions to manage the risks of severe diarrhoea and effects on the liver. These recommendations are the outcome of a re-examination of the PRAC’s November 2013 opinion to suspend marketing authorisations for diacerein.

Summary of PRAC recommendation on Diacerein

PRAC recommends updates to the product information of zolpidem

The PRAC has recommended changes to the product information of zolpidem-containing medicines. These changes are aimed at further minimising the known risks of next-morning impaired driving ability and mental alertness (including somnambulism) with these medicines.

Summary of PRAC recommendation on Zolpidem