Pharmacovigilance

News from the CHMP and CMDh – October 2013

30.10.2013

The Co-ordination Group for the Mutual Recognition and Decentralised Procedure for Human Medicines (CMDh) has adopted the PRAC recommendations about restrictions of use of hydrxyethyl-starch containing solutions (HES) and restrictions of use of short acting beta agonists in obstetric indications.
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) confirmed its previous recommendations about the restriction of use of dihydroergotoxin and metoclopramide and recommended restriction of use of intravenous forms of nicardipine.
More information is accessible under the following link.

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New restrictions on use of medicinal products containing ergot alkaloids

16.10.2013

The European Commission has adopted the Recommendations of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on restrictions on the use of medicinal products containing derivatives of ergot alkaloids. These restrictions refer only to dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine. These active substances may no longer be used in the following indications where the risks outweigh the benefits: symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer’s disease and other dementia), ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD, stage II), ancillary treatment of Reynaud’s syndrome, ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, acute retinopathies of vascular origin, prophylaxis of migraine headache, orthostatic hypotension and symptomatic treatment of veno-lymphatic insufficiency. This conclusion is based on the review of data indicating increased risk of fibrosis (formation of excessive connective tissue that may damage organs and organism structure) and ergotism (symptoms of ergot intoxication, as cramps and obstructions in blood circulation) after the use of these medicines.
You may find detailed information under the following link.

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Dear Healthcare professional Letter about the new contraindication and reminder for monitoring liver function when using agomelatine (Valdoxan/Thymanax 25 mg film-coated tablets

15.10.2013

Servier Pharma d.o.o., the marketing authorisation holder for medicinal products Valdoxan 25 mg film-coated tablets and Thymanex 25 mg film-coated tablets (agomelatine) is, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sending a letter to healthcare professionals to inform them about the introduction of a new contraindication and to remind them for a need for liver function monitoring with the use of agomelatine.
Deatiled information and the Dear Healthcare Professional Letter are available under the folowing link.

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The PRAC news – October 2013

14.10.2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) gave new recommendations on its October 2013 meeting about the safe use of medicines in European Union Member States.
The PRAC has concluded that the benefits of combined hormonal contraceptives continue to outweigh their risks. The PRAC confirmed the recommendation that hydrohyethyl-starch (HES) solutions must no longer be used to treat patients with sepsis or burn injuries or critically ill patients. In addition, the review of valproate-containing medicines and related substances and their use in pregnant woman has started.
Detailed information is accessible under the following link.

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PRAC confirms that hydroxyethil-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients

11.10.2013

The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has completed the review of hydroxyethil-starch-containing (HES) solutions following an assessment of new information and commitments for additional studies and risk minimisation activities. The PRAC confirmed that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients, because of an increased risk of kidney injury and mortality. HES solutions may, however, continue to be used in patients to treat hypovolaemia (low blood volume) cause by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out.
You may find more detailed information under the following link:

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Dear Doctor Letter about the possible vaccine leackage due to crack or defects on the plastic junction connecting the needle and syringe in vaccines with Readyject syringe for products FSME-IMMUN 0,25 ml Junior and FSME-IMMUN 0,5 ml

10.10.2013

The company Agmar d.o.o., the marketing authorisation holder for vaccines FSME-IMMUN 0,25 ml Junior, suspension for injection in pre-filled syringe, vaccine against tick-borne encephalitis, inactivated, is sending a letter on behalf of the manufacturer, Baxter, and in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) to doctors about an important information related to use of vaccines FSME-IMMUN 0.25 ml Junior and FSME-IMMUN 0,5 ml with Readyject syringe (pre-filled syringe with attached syringe).
Deatailed information and the Dear Doctor Letter are accessible under the following link:

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Dear Healthcare Professional Letter about the introduction of new warning on possible serotonin syndrome that may occur under co-administration of medicinal products Fentanyl or Durogesic transdermal patches with serotonergic medicines

09.10.2013

The marketing authorisation holder, Johnson & Johnson S.E. d.o.o. is sending a letter, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) to healthcare professionals with the aim to warn about a possible occurrence of serotonin syndrome in cases where serotonergic medicines are administered concomitantly with the marketing authorisation holder’s fentanyl-containing medicinal products Fentanyl and Durogesic Transdermal Patch.

The marketing authorisation holder undertook a review to assess the available evidence for the possibility of serotonin syndrome when serotonergic medicines are administered concomitantly with fentanyl-containing medicinal products that are currently licensed by tha marketing authorisation holder. Based on the results and conclusions of this review, updates to the Summary of Product Characteristic for medicinal products Fentanyl and Durogesic Transdermal Patch have been made to include a warning regarding the potential for serotonin syndrome to occur when these medicinal products are used concurrently with other serotonergic medicines.

You may view the Dear Healthcare Professional Letter under the following link.

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European Medicines Agency begins to publish recommendations based on safety signals

07.10.2013

The European Medicines Agency (EMA) has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC). The document covers all safety signals discussed during the September 2013 PRAC meeting and the recommendations given for each of them. It includes PRAC recommendations for centrally and nationally authorised medicines.
The evaluation of safety signals by the PRAC has been implemented with the new pharmacovigilance legislation. A cumulative list of all signals discussed at the PRAC since September 2012 available on the EMA web pages or under the following link.

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Dear Healthcare Professional Letter about the risk of appearance of an intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients treated with risperidone or paliperidone

05.10.2013

Janssen-Cilag International NV and Johnson & Johnson S.E. d.o.o., the marketing authorisation holders in the Republic of Croatia for medicinal products Xeplion 25 mg, 50 mg, 75 mg, 100 mg suspension for injection with prolonged release (paliperidone), Invega 1,5 mg, 3 mg, 6 mg, 12 mg tablets with prolonged release (paliperidone), Rispolept Consta 25 mg, 37,5 mg, 100 mg powder and solvent for suspension for injection with prolonged release for intramuscular application (risperidone), Rispolept 1 mg, 2 mg, 3 mg, 4 mg film-coated tablets (risperidone) and Rispolept 1 mg/ml solution for oral use (risperidone), have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals about the risk of appearance of an intraoperative floppy iris syndrome during cataract surgery in patients treated with risperidone paliperidone.

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