Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 November 2013
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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
Recommendations by PRAC
| Nicotinic-acid-related substances (Acipimox) |
|---|
Article-31 referral: Nicotinic-acid-related substances (Acipimox) |
| Diacerein-containing medicines for oral administration |
|---|
Article-31 referral: Diacerein-containing medicines for oral administration
PRAC recommends suspension of diacerein-containing medicines |