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EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is expected to prevent many cases of cervical cancer (cancer of the neck of the womb) and various other cancers and conditions caused by HPV. The current review, which is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness). Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected. While the review is ongoing there is no change in recommendations for the use of the vaccine.
The press release is available by clicking here .
We would be grateful if you could disseminate this email to anyone else who might be interested in this document.
With kind regards,
Nathalie Macle
Stakeholders and Communication Division
European Medicines Agency
30 Churchill Place
London, E14 5EU
United Kingdom
Tel +44 (0)20 3660 7284
nathalie.macle@ema.europa.eu
EMA press release
Dear colleagues and friends,
I invite you to read the reassuring press release of the European Medicines Agency ( EMA) (October 11, 2013) . This opinion of the EMA is important to know and make known to the doctors, midwives and pharmacists , as well as for users of combined hormonal contraceptives.
EMA’s statements confirm that taking into account the reevaluation of the risk of VTE and ATE of estroprogestative contraceptives , the benefits of these contraceptives continue to exceed their risks.
This is at the request of France that the PRAC (EMA 's Phamaco -vigilance Risk Assessement Committee) took up this reevaluation . Confidently expect notice of the CHMP (Committee for Medical Products ) meeting in November 2013 and the final opinion of the EMA on the thromboembolic risk contraceptives EP.
Look especially forward the reaction of the French health authorities.
Dr. David SERFATY
President of FSG
Click here to read the press release
Women With Autoimmune Rheumatic Diseases: Considerations Before, During, and After Pregnancy
Welcome message to Pr. Andréa GENAZZANI, the new President of the European Society of Gynecology
Dear Friends and Collegues, As President of the European Society of Gynecology (ESG), it is an honor for me to follow Prof. David Serfaty. The Society, after the success of our last Congress in Copenhagen, is now ready to increase its visibility and presence all around Europe in collaboration with the National Societies of Gynecology and Obstetrics. In our next Congress, the 10th Congress of the European Society of Gynecology, chaired by Prof. J.M. Foidart, which will be held in the magnificent scenario of Bruxelles from 18th to 21st September 2013 at the Square Meeting Centre, we will reconfirm our engagement in the development of the discipline in the various chapters of basic science and clinical aspects of Obstetrics and Gynecology. The role of the European Society of Gynecology for the development of our daily practice to improve the women health and the obstetric care all around Europe, will be reconfirmed non only by our congress, but also by the organization of the Albert Netter days of the European Society of Gynecology which will be held in Capri 09th -11th October 2014 In Bruxelles we will have the General Assembly of the ESG, where all of you are invited to discuss and to offer proposals for the development of our Society and for the improvement of the Gynecology and Obstetrics care all around Europe. Yours sincerely, Andrea R. Genazzani
European Medicines Agency starts safety review of Diane 35 and its generics
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) formally started a safety review of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35μg), associated names and its generics at its 4-7 February 2013 meeting.
European Medicines Agency starts safety review of Combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate
Following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC), the European Medicines Agency has started two safety reviews:
Combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate
The review of these contraceptives was requested by the French medicines agency ANSM following concerns in France about the risk of venous thromboembolism (VTE or blood clots in veins). The EMA will now review all available data on the risk of VTE with these contraceptives and issue an opinion on whether any changes are needed to their prescribing advice across the EU.
The press release is available for consultation by clicking here.
Human medicines highlights - Issue 55 - September 2013
The January 2013 issue of the European Medicines Agency's newsletter 'Human medicines highlights' is available here.
No.1 Newsletter of the ESG
Dear colleagues,
Dear Friends,
Here is the first edition of the European Society of Gynecology’s newsletter.
Thanks to the involvement of the office’s members and to the ESG board, I would like this newsletter to become not only a link between the ESG’s managers but foremost, a link between all of the ESG’s members.
This newsletter will keep you updated of the several conferences in which the ESG has taken part of. Also, the doctors Anne Grimard, Margarida Moreira and Ulysse Gaspard made a call to the member’s contribution.
The next editions will most likely talk about the excellent assessment of the ESG’s 9th congress in Copenhagen organized by Sven Olaf Skouby and by the ICS.
In the last place, this newsletter could give some professional and scientific information “flash” related to the gynecologic field.
I wish a long life and success to the ESG’s newsletter and thank those who’ll pass it through.
Dr David Serfaty
European Society Of Gynecology President
The Outcome of 770 PIP Breast Implants
Reports of an unexpectedly high early rupture rate and the use of an inappropriate gel resulted in the Poly Implant Prothese (PIP) breast implants being recalled in 2010. This medical crisis subsequently developed into an international public and political crisis. Over 500,000 PIP implants were inserted worldwide:> 45,000 in the UK, >30,000 in France.
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