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• W2896035871 abstract "To the Editors: We read with interest the recent article by Ben Jmaa et al,1 which examined cardiorespiratory events after immunization in preterm infants. Since 2008, the former “European Agency for Evaluation of Medicinal Products” [today: European Medicines Agency] recommended hospitalization and cardiorespiratory monitoring of preterm babies born <28 weeks of gestational age during primary immunization because of the risk of apnea and bradycardia.2,3 The current recommendations and algorithms mainly refer to standard vaccinations [including diphtheria-tetanus-acellular pertussis vaccines including Haemophilus influenzae b, inactivated poliovirus vaccine, Hepatitis B, pneumococcal and meningococcal vaccines and Rotavirus]. Apnea is an adverse drug reaction which was also identified from post-marketing surveillance of monoclonal antibody prophylaxis with Palivizumab (Synagis; AbbVie Ltd, Maidenhead, United Kingdom) which is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease including preterm infants born at 35 weeks of gestation or less than 6 months of age at the onset of the RSV season. Nevertheless, the risk of cardiorespiratory events after recurrent administration of Palivizumab has not yet been evaluated in detail. Here we report on a 3-month-old male infant (born at 28 + 1 weeks of gestation, birth weight 925 g) presenting with apnea, bradycardia and desaturation approximately 8 hours after the first dose of Palivizumab. The emergency physician succeeded in stabilizing the child with mask ventilation. In the further course of hospitalization the infant was treated symptomatically. At the time of Palivizumab administration, the child was suffering from mild wheezing which was treated with salbutamol. Rhino/enterovirus and parainfluenza virus 1 could be identified in the nasopharyngeal swab in the BIOFIRE® FILMARRAY® Respiratory Panel (bioMérieux), whereas the test for RSV was negative. According to the German National Drug Law, marketing authorization holders have to report suspected serious adverse reactions to the national competent authority and as of November 22, 2017, to the European Medicines Agency. In addition, according to the professional law, health care professionals are obliged to report adverse reactions to the Drug Commission of the German Medical Association which is the scientific expert committee for drug-related matters of the German Medical Association. Individual case safety reports (ICSRs) regarding Palivizumab are stored in the adverse drug reaction database of the Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Institut, PEI, Langen, Germany. ICSRs from Germany after administration of Palivizumab addressing cardiorespiratory events as of approval by the European Commission in August 1999 until 13 November 2017 were reviewed. Since launch on the German market in September 1999, a total of 93 ICSRs with apnea, apnea/bradycardia, desaturations or cardiorespiratory event were received, of whom 29 were without evidence of an accompanying infection. However, in the vast majority of ICSR, concurrent infections (n = 64), mostly respiratory infections with RSV (n = 39), were reported. Most of reported cardiorespiratory events occurred within 48 hours after Palivizumab injection (33/93; 35.5%), 23 cases (24.7%) without and 10 cases (10.8%) with an accompanying infection. In 20 further cases, the cardiorespiratory events occurred >48 hours; in 40 cases, no exact time point of Palivizumab injection was reported. There were 3 fatal case reports in which the cardiorespiratory events occurred within 48 hours after Palivizumab injection all of them without concomitant infection but with a medical history of severe congenital heart disease, a condition which is per se associated with high risk for cardiorespiratory events. Among the 30 ICSR with available information on dose number, in 10 ICSR the events occurred after the first dose, in 7 ICSR after the second dose, and in 13 ICSR after more than 2 previous Palivizumab doses. Neither in a systematic review on safety and effectiveness of Palivizumab4 nor in a report from the German Palivizumab registry,5 apnea, bradycardia or desaturations were found to be a safety issue associated with the administration of Palivizumab. The underlying medical conditions of prematurity, bronchopulmonary dysplasia and congenital heart disease indicated for Palivizumab and infections have to be considered as confounders because of their known association with cardiorespiratory events. Several studies have investigated the frequencies of cardiorespiratory events after routine immunization in preterm infants and detected no association with specific vaccines.2,3 In conclusion, based on the data reviewed, there is insufficient information to assess the association of cardiorespiratory events after administration of Palivizumab. Tobias Tenenbaum, MDPediatric Infectious Diseases and PulmonologyUniversity Children’s Hospital MannheimHeidelberg UniversityMannheim, Germany Ursula Drechsel-Bäuerle, MScDoris Oberle, MD, PhD, MScDepartment Safety of Medicinal Products and Medical DevicesFederal Institute for Vaccines and BiomedicinesPaul-Ehrlich-InstitutLangen, Germany" @default.
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• W2896035871 date "2018-11-01" @default.
• W2896035871 modified "2023-09-26" @default.
• W2896035871 title "Cardiorespiratory Events After Monoclonal Antibody Prophylaxis With Palivizumab" @default.
• W2896035871 cites W1975474854 @default.
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• W2896035871 doi "https://doi.org/10.1097/inf.0000000000002017" @default.
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