WC500165698

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Furthermore the number of cases seen in the observational databases was higher than expected (even acknowledging that data were obtained from observational databases and not all the cases represent adverse reactions) and the reasons for this should be further clarified. Summary of recommendation(s) The MAHs for of all bupropion-containing medicines should continue monitoring cases of pancytopenia in future PSURs. Furthermore the MAHs should respond to a request for supplementary information concerning effects on red cell parameters and on haematopenia with a specific focus on anaemia, leucopenia, lymphopenia and thrombocytopenia within 60 days. 4.3.2. Goserelin (NAP) Signal of long-duration flushing and hyperhidrosis Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure scope: Evaluation of the MAH’s responses to PRAC recommendation as adopted at PRAC in November 2013 EPITT 17698 - Follow-up November 2013 MAH(s): Astra Zeneca, various Background For background information, see PRAC minutes of 4-7 November 2013. The MAH replied to the request for information on the signal of long-duration flushing and hyperhidrosis and the responses were assessed by the Rapporteur. Discussion The PRAC discussed the additional information on the post-marketing cases and information from the published literature. Whilst the limitations of the post-marketing data were noted it was agreed that there were a small number of cases of hot flushes and/or hyperhidrosis which prolonged after stopping goserelin that were not explained by comorbidities/concomitant treatments or the patient’s age. In addition to these cases, there was strong supporting evidence from published clinical data 8 showing that in men with prostate cancer the suppression of luteinising hormone (LH) and testosterone levels (and corresponding symptoms of sweating and hot flushes) can persist for many months after goserelin was stopped. Data showed that the recovery of hypothalamic-pituitary-testicular axis function after goserelin administration was variable and for some patients was protracted. 8 Dearnaley DP, Norman AR, Shahidi M, Re: Time to normalization of serum testosterone after 3-month luteinizing hormone-releasing hormone agonist administered in the neoadjuvant setting: Implications for dosing schedule and neoadjuvant study consideration. (Letter). Journal of Urology 1999;162:170. Meinhardt W, Horenblas S, Re: Time to normalization of serum testosterone after 3-month luteinizing hormone-releasing hormone agonist administered in the neoadjuvant setting: Implications for dosing schedule and neoadjuvant study consideration. (Letter) Journal of Urology 1999;162:170-171. Nejat RJ, Rashid HH, Bagiella E, Katz AE, Benson MC, A prospective analysis of time to normalization of serum testosterone after withdrawal of androgen deprivation therapy Journal of Urology 2000;164:1891- 1894. Pickles T, Agranovich A, Berthelet E et al. Testosterone recovery following prolonged adjuvant androgen ablation for prostate carcinoma. Cancer 2002;94:362-7. Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 20/64
Taken together, the available evidence indicated that, in some patients, goserelin can cause flushing and hyperhidrosis that persist after cessation of treatment and for a period of time that is longer than expected. The PRAC agreed that this should be reflected in the product information. Summary of recommendation(s) The MAHs for the reference, nationally authorised goserelin-containing medicines 9 should be requested to submit to the NCA within 60 days a variation to update the product information to include that hyperhidrosis and hot flushes may continue after stopping the treatment. The MAHs of generic products should then be requested to submit to the EMA or to the NCA, as applicable, a variation to align their product information to that of the originator. For the full PRAC recommendations, see EMA/PRAC/144622/2014 published on the EMA website on 24/03/2014. 4.3.3. Quetiapine (NAP) Signal of suicidality in major depressive disorder (MDD) patients Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure scope: Evaluation of the MAH’s responses to PRAC recommendation as adopted at PRAC in October 2013 EPITT 17709 - Follow-up October 2013 MAH(s): various Background For background information, see PRAC minutes of 7-10 October 2013. The MAH replied to the request for information on the signal of suicidality in major depressive disorder (MDD) patients and the responses were assessed by the Rapporteur. Discussion The PRAC discussed the interpretations of the results of the previously discussed General Practice Research Database (GPRD) study which was compared with the PHARMO, an epidemiological study which was completed in 2011. Furthermore data from other studies, in particular the results of a prescription-event monitoring study concluded at the end of 2013 (mPEM), and the clinical trial database were also reviewed. The PRAC discussed the strength and limitations of the evidence provided and agreed that overall there was a higher mortality rate in Seroquel XR (quetiapine) user groups, especially in MDD patients; however confounding by indication might explain at least part of these findings. A higher mortality rate in elderly patients with dementia in comparison with elderly without dementia was also observed according to the data submitted. However, no clear conclusions can be drawn at the moment based on the currently available data on both populations. The PRAC noted that, currently, 9 In line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, the marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations made public by means of the European medicines webportal established in accordance with Article 26 of Regulation (EC) No 726/2004 (EMA website). For nationally authorised medicines, it is the responsibility of the National Competent Authorities of the Member States to oversee that these recommendations are adhered to Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 21/64
Page 1 and 2: 10 April 2014 EMA/PRAC/253432/2014
Page 3 and 4: Table of contents Note on access to
Page 5 and 6: 10.2. Timing and message content in
Page 7 and 8: 15.1.8. Dronedarone - MULTAQ (CAP)
Page 9 and 10: 1. Introduction 1.1. Welcome and de
Page 11 and 12: 3.2.2. Bromocriptine (NAP) Review
Page 13 and 14: Discussion The PRAC discussed the e
Page 15 and 16: Background Cefepime is a cephalospo
Page 17 and 18: Summary of recommendation(s) The M
Page 19: conducted in the US Veterans Affair
Page 23 and 24: eported in 38.5% of the cases. Amon
Page 25 and 26: 5.2. Medicines already authorised R
Page 27 and 28: Summary of advice The RMP version
Page 29 and 30: Background Colistimethate sodium is
Page 31 and 32: The next PSUR should be submitted i
Page 33 and 34: Administrative details: Procedure n
Page 35 and 36: Summary of advice Based on the revi
Page 37 and 38: 10.3. Other requests None 11. Other
Page 39 and 40: The PRAC endorsed the final version
Page 41 and 42: 12.8. Post-authorisation Safety Stu
Page 43 and 44: 14. ANNEX I Risk Management Plans 1
Page 45 and 46: 14.1.13. Tobramycin Evaluation of
Page 47 and 48: 14.2.8. Amifampridine - FIRDAPSE (C
Page 49 and 50: Procedure scope: Grouping of three
Page 57 and 58: 16.2. Protocols of PASS non-imposed
Page 59 and 60: Procedure scope: Evaluation of fina
Page 63 and 64: PRAC members and alternates Country

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