News and Educations

News from PRAC – June 2013


The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) made recommendations for the EU member states on four safety referrals at its June 2013 meeting:

PRAC recommends restricting the use of codeine for pain relief in children

PRAC has recommended a series of measures to address safety concerns regarding the use of codeine-containing medicines when used for managing pain in children. These measures include the use of codein-containing medicines only for treating acute moderate pain in children over 12 years of age, and only if the pain cannot be relieved using other painkillers, adding the warning that children with conditions involving breathing problems should not use codein and that codein should not be used at all for children under 18 years of age who undergo surgery for the removal of tonsils or adenoids to treat sleep apnea.

PRAC recommends the same precautions for diclofenac as for selective COX-2 inhibitors

PRAC has concluded that the effects of the systematic use of diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors. This particularly applies to instances when diclofenac is used at a high dose (150 mg daily) and for long term treatment. PRAC concluded that the benefits of diclofenac still outweigh the risks, but recommend that the precautions already in place regarding the use of COX-2 inhibitors to minimise the risk of arterial thromboembolic events (blood clots in arteries) should be applied to diclofenac.

PRAC recommends the suspension of infusion solutions containing hydroxyethyl starch

PRAC has concluded that the benefits of infusion solutions containing hydroxyethyl starch (HES) no longer outweigh their risks and have therefore recommended the suspension of marketing authorization for these medicines. Infusion solutions containing HES are used to restore blood volume in cases of hypovolemia (loss of blood volume caused by dehydration or bleeding) and hypovolemic shock (sudden reduction in blood pressure due to reduction in blood volume). PRAC concluded that patients treated with HES are at a greater risk of kidney injury requiring dialysis, as well as at a greater risk of mortality, when compared to crystalloids, which are also used for the treatment of hypovolemia and hypovolemic shock.

PRAC recommends the restriction of use of flupirtine-containing medicines

PRAC has recommended that oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults that cannot use other painkilles (such as non-steroidal anti-inflammatory drugs and weak opioids) and that the treatment should not exceed two weeks due to the risk of liver damage. Additionally, liver function should be monitored every week, and should any signs of liver damage occur, the treatment should be stopped. PRAC has also recommended that these medicines should not be used in patients with pre-existing liver disease, patients suffering from liver disease and patients taking other medicines that cause liver damage.

Additional information

Since these four PRAC recommendations concern medicinal products approved through national procedure, they will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). CMDh is a regulatory body representing the EU Member States.
Should the CMDh reach a decision by consensus, the decision will be directly implemented by the EU Member States where the medicines are authorised. If the decision is adopted by a majority vote, it will be sent to the European Commission for the adoption of an EU-wide legally binding decision.
More about PRAC recommendations from June 2013 can be read here.