Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 November 2013

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08/11/2013

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 November 2013

PRAC updates on the risks of serious vascular occlusive events associated with Iclusig

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed new information on the cancer medicine Iclusig (ponatinib) that suggests that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur at a higher rate than initially observed at the time of granting the European Union (EU) marketing authorisation in July 2013.

For more information, please refer to the press release on Iclusig.

PRAC recommends suspension of diacerein-containing medicines

The PRAC has also recommended the suspension of diacerein-containing medicines across the EU. This follows a review which concluded that the benefits of diacerein, used to treat symptoms of osteoarthritis and other degenerative joint diseases, did not outweigh its risks, particularly the risk of severe diarrhoea and potentially harmful effects on the liver.

For more information please see the table below.

PRAC recommends restrictions of use for acipimox

The PRAC has recommended that medicines containing acipimox should have their marketing authorisations amended to ensure that they are used across the EU only as an additional or alternative treatment to lower triglyceride levels in patients with type IIb and type IV hyperlipoproteinaemia.

For more information please see the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 4-7 November 2013

 

Recommendations by PRAC

Nicotinic-acid-related substances (Acipimox)

Article-31 referral: Nicotinic-acid-related substances (Acipimox)
 

Summary of PRAC recommendation

 

Diacerein-containing medicines for oral administration

Article-31 referral: Diacerein-containing medicines for oral administration

 

Summary of PRAC recommendation

 

Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu