pharmacovigilance working party (phvwp)
The Pharmacovigilance Working Party (PhVWP)
provides recommendations about the risks of medicinal products
after their authorisation for the European market. This
advice concerns, for example, the evaluation of
possible adverse reactions and the risks of medicinal
products. The MEB is represented by Sabine Straus (Head of the
Pharmacovigilance Department) in this working party of the
CHMP in the field of pharmacovigilance. Eugène van Puijenbroek
has been appointed an independent expert (co-opted member)
of the PhVWP and works as Head of the Analysis Department at the
Netherlands Pharmacovigilance Centre Lareb.
The PhVWP publishes a
monthly report about the most important advices and points of
interest from the meetings.
The reports include:
- information about products that are not authorised through the
centralised procedure
- recommendations to authorisation agencies in the member states
concerning the benefits and risks of medicinal products
- information about discussions concerning the risks of a
particular medicinal product
- definitive guidelines in the field of pharmacovigilance
- draft guidelines and similar products in the field of
pharmacovigilance which are available for consultation
- contributions of the PhVWP to public meetings or
consultations
- general topics about the organisation of the European
authorisation network
March 2012
Monthly Report - Pharmacovigilance Working Party
(PhVWP) March 2012 plenary meeting
Subjects:
Safety concerns
- Perfalgan (paracetamol) 10 mg/ml solution for infusion – Risk
of medication errors resulting in overdose
- Proton-pump inhibitors – Risk of bone fracture
- SSRIs – Update of product information to reflect animal data on
the effect on sperm quality and an evaluation of its human
relevance
- Lovastatin – Risk of new onset diabetes
***
February 2012
Monthly Report - Pharmacovigilance Working Party
(PhVWP) February 2012 plenary meeting
Subjects:
Safety concerns
- Docetaxel Actavis – Risk of infusion site reactions
Guidelines and general matters
- Good Pharmacovigilance Practices (GVP) for the EU – Release for
public consultation
***
January 2012
Monthly Report -
Pharmacovigilance Working Party (PhVWP) January 2012 plenary
meeting
Subjects:
Safety concerns
- Ethinylestradiol + drospirenone-containing oral contraceptives
(Yasmin, Yasminelle and other products) – Risk of venous
thromboembolism
***
December 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) December 2011 plenary meeting
Subjects:
Safety concerns
- Gonatropin-releasing hormone (GnRH) agonists – Risk of
depression
- HMG-CoA reductase inhibitors – Risk of new onset diabetes
- Methotrexate – Risk of overdose due to erroneous daily intake
of the weekly dose in rheumatologic and dermatologic
indications
- Montelukast – Risk of psychiatric adverse reactions in
children
- Proton-pump inhibitors – Risk of hypomagnesaemia with long-term
use
Guidelines and general matters
- Work Plan for the CHMP Pharmacovigilance Working Party
2012
- CHMP Guideline on Immunogenicity Assessment of Monoclonal
Antibodies Intended for In-vivo Clinical Use
***
November 2011
Monthly Report - Pharmacovigilance Working Party
(PhVWP) November 2011 plenary meeting
Subjects:
Safety concerns
- Atomoxetine – Updated information on effects on blood pressure
and heart rate
- Escitalopram – Risk of QT interval prolongation
- Rosuvastatin - Risk of gynaecomastia
- Tibolone – Risk of venous thromboembolism, myocardial
infarction, breast cancer and ovarian cancer
- Topiramate – Updated information on risk of congenital
malformations
***
October 2011
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) October 2011 plenary meeting
Subjects:
Safety concerns
- Antiepileptics – Risk of bone disorder
- Citalopram – Risk of QT interval prolongation
- Domperidone - Risk of cardiac disorders
Guidelines and general matters
- ICH Implementation Guide (ICH-E2B(R3)) for the International
Standard for the Electronic Transmission of Individual Case Safety
Reports
***
September 2011
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) September 2011 plenary meeting
Subjects:
Safety concerns
- Active substances with a known risk of Stevens-Johnson syndrome
and toxic epidermal necrolysis (allopurinol, carbamazepine,
lamotrigine, phenobarbital, phenytoin, meloxicam, piroxicam,
tenoxicam, nevirapine, sulfadiazine, sulfadoxine, sulfafurazole,
sulfamethoxazol and sulfasalazine)
***
July 2011
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) July 2011 plenary meeting
Subjects:
Safety concerns
- Antipsychotics - Risk of extrapyramidal effects and withdrawal
symptoms in newborns after exposure during pregnancy
- Fusidic acid - Risk of rhabdomyolysis due to interaction with
HMG-CoA reductase inhibitors
- Plantago ovata (syn.: P.isphagula) - Risk of allergic reactions
after prolonged occupational exposure
- Reboxetine - Confirmation of positive benefit-risk
balance
Guidelines and general matters
***
June 2011
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) June 2011 plenary meeting
Subjects:
Safety concerns
- Beta-blockers for ophthalmic use – Risk of systemic adverse
reactions.
- GEMCITABINE ACTAVIS – Risk of adverse reactions due to
increased alcohol concentration after reconstitution error.
- Hydrochlorothiazide – Use during breast-feeding.
- Testosterone 10% for topical use – Risk of virilisation in
children after exposure through interpersonal skin
contact.
Guidelines and general matters
- Meetings of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) in June 2011.
- Guide on the interpretation of spontaneous case reports of
suspected adverse reactions to medicines.
- Study of influential stakeholders’ expectations and attitudes
regarding benefit-risk communication by the European Medicines
Agency.
- Driving under the Influence of Drugs, Alcohol and Medicines -
The Integrated Project DRUID under the European Commission’s 6th
Framework Programme.
***
May 2011
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) May 2011 plenary
meeting
Subjects:
Safety concerns
- Ethinylestradiol + drospirenone-containing oral contraceptives
(YASMIN, YASMINELLE and other products) – Risk of venous
thromboembolism.
- Yttrium citrate (90Y) – Risk of osteonecrosis with injection
for inflammatory rheumatism of the knee.
Guidelines and general matters
- New term of PhVWP Patient Observers.
***
April 2011
> download Monthly Report - Pharmacovigilance Working Party (PhVWP)
April 2011 plenary meeting
Subjects:
Safety concerns
- Bricanyl Turbohaler (terbutaline) - Effect of physical
impact on accuracy of dose delivery and recommended 100 dose pack
size
- Isotretinoin – Risk of psychiatric reactions
***
March 2011
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) March 2011 plenary
meeting
Subjects:
Safety concerns
- High-ceiling diuretics - Evidence does not confirm risk of
basal cell
***
Februari 2011
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) Februari 2011 plenary
meeting
Subjects:
Safety concerns
- Montelukast – Reports of psychiatric and behaviour-related
adverse reactions
- Paracetamol – Available evidence does not support a causal
relationship between paracetamol and asthma in children after
exposure in pregnancy or use in early infancy
Guidelines en general matters
- European Medicines Agency’s Transatlantic Workshop on
Drug-Related Progressive Multifocal Leukoencephalopathy
***
Januari 2011
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) Januari
2011 plenary meeting
Subjects:
Safety concerns
- Insulin products – Consistent product information regarding the
risk of heart failure with concomitant use of
pioglitazone
Guidelines and general matters
- New legislation for pharmacovigilance in the European
Union
***
December 2010
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) December 2010 plenary
meeting
Subjects:
Safety concerns
- Fluoroquinolones – Risk of QT interval prolongation
Guidelines and general matters
- Work plan for the CHMP Pharmacovigilance Working Party
2011
- Meetings of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) in November 2010
***
November 2010
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) November 2010 plenary
meeting
subjects:
Safety concerns
- Corticosteroids for inhalational or intranasal use – Risk of
psychiatric, behavioural and other systemic adverse
reactions
Guidelines and general matters
- European Network of Centres for Pharmacoepidemiology and
Pharmacovigilance (ENCePP)
- Research on Direct Healthcare Professional Communications
(DHPCs) in the Netherlands
***
Oktober 2010
> download Monthly Report -
Pharmacovigilance Working Party (PhVWP) October 2010 plenary
meeting
subjects:
Safety concerns
- Adrenaline-containing auto-injectors EPIPEN/ALTELLUS – Risk of
failure of self-injection due to labelling
- Bisphosphonates for oral use – Risk of oesophageal irritation
but insufficient evidence to conclude a causal relationship with
oesophageal cancer
- Long-acting beta2-adrenoceptor agonist bronchodilators
formoterol and salmeterol – Review of safety in the management of
asthma
***
September 2010
> download
Monthly Report -
Pharmacovigilance Working Party (PhVWP) September 2010 plenary
meeting
subjects:
Safety concerns
- Benzydamine – Risk of adverse reactions after incorrect oral
intake
- Lamotrigine – Risk of aseptic meningitis
- Tamoxifen – Risk of reduced therapeutic response in patients
who are poor CYP2D6 metabolisers or use medicines inhibiting
CYP2D6
Guidelines and general matters
- Election of PhVWP Vice-Chairperson
- New legislation for pharmacovigilance in the European
Union
- 1st EMA Scientific Workshop on Nanomedicines on 2-3 September
2010
***
August 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) September 2010 plenary meeting
subjects:
Safety concerns
- Benzydamine – Risk of adverse reactions after incorrect oral
intake
- Lamotrigine – Risk of aseptic meningitis
- Tamoxifen – Risk of reduced therapeutic response in patients
who are poor CYP2D6 metabolisers or use medicines inhibiting
CYP2D6
Guidelines and general matters
- Election of PhVWP Vice-Chairperson
- New legislation for pharmacovigilance in the European
Union
- 1st EMA Scientific Workshop on Nanomedicines on 2-3 September
2010
***
July 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) July 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
- Camphor for external or inhaled use – Risk of toxic effects
after accidental oral intake
- Isotretinoin for oral use – Risk of erythema multiforme,
Stevens Johnson syndrome and toxic epidermal necrolysis
Guidelines and general matters
- Medical Dictionary for Drug Regulatory Activities (MedDRA) –
List of Important Medical Event Terms (IME)
- European Programme in Pharmacovigilance and
Pharmacoepidemiology (Eu2P)
***
June 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) June 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
Guidelines and general matters
***
May 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) May 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
- Low-molecular-weight iron dextran – Risk of allergic
reactions
- Rosuvastatin – Risk of diabetes
***
April 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) April 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
- Dipyridamole in combination with acetylsalicylic acid – No
evidence for increased risk of ischaemic stroke versus
acetylsalicylic acid alone in the European population
- Latanoprost – No evidence for risk of malignant melanomas of
the eye and skin
***
March 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) March 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
- Antidepressants – Risk of bone fractures
- Isotretinoin for oral use – Risk of erythema multiforme
- Lamotrigine – No evidence of increased risk of fatal liver
failure
- Omeprazole and esomeprazole – Risk of reduced plasma levels of
clopidogrel due to interaction
- PERFALGAN (paracetamol) 10 mg/ml solution for infusion – Risk
of dosing errors in infants resulting in overdose with serious
outcome
- Serotonergic antidepressants – Risk of persistent pulmonary
hypertension of the newborn
- YASMIN/YIRA (ethinylestradiol 30μg + drospirenone) – Risk of
venous thromboembolism
Guidelines and general matters
- CHMP Guideline on Duplicate Detection and Management of
Individual Cases and Individual Case Safety Reports
***
February 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) February 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
- Fluoxetine – Risk of cardiovascular birth defects
Guidelines and general matters
- Pharmacovigilance for medicinal products used against novel
Influenza A (H1N1) virus
- Appointment of three new Co-opted PhVWP Members
***
January 2010
> download Monthly Report - Pharmacovigilance Working Party
(PhVWP) January 2010 plenary meeting
subjects:
PhVWP discussions on safety concerns
- Hormone Replacement Therapy containing oestrogen with and
without progesterone – 3rd revision of Core Summary of Product
Characteristics
- Salmon calcitonin – No association with progression of prostate
cancer
- Valproic acid – Interaction with carbapenems
Guidelines and general matters
- Pharmacovigilance for medicinal products used against novel
Influenza A (H1N1) virus