Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

Casajuana, J.; Iglesias, Begoña; Fàbregas, Mireia; Fina, Francesc; Vallès, Joan-Antoni; Aragonés, Rosa; Benítez, Mència; Zabaleta, Edurne

doi:10.1186/1471-2326-8-1

Cited by 29 publications

(21 citation statements)

References 7 publications

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“…24 However, studies have shown that patients on anticoagulation therapy may receive the vaccine via the IM route without an increased risk of hematoma because the immunological response following either an IM or SQ injection is similar. 11,25 Therefore, the route of administration is not expected to be a confounder in assessing the effect of influenza vaccine on INR. Likewise, time after follow-up did not appear to affect whether a difference was observed in INR levels following immunization.…”

Section: Prospective Studies -Placebo Controlledmentioning

confidence: 99%

Effect of influenza vaccination on international normalized ratio during chronic warfarin therapy

Kuo

Brown

Clinard

2012

Journal of Clinical Pharmacy and Therapeutics

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What is known and Objective:: Warfarin is a widely used anticoagulant, well‐known for its interactions with medications and foods. Vaccinations, particularly the influenza vaccine, have been thought to potentially interfere with anticoagulation response in those on chronic warfarin. Our objective was to systematically review the literature to assess the validity and clinical significance of this association. Methods:: A primary literature search was performed using MEDLINE (1966 – June 2011) and EMBASE (1980 – June 2011). Additional studies were obtained by performing a manual bibliographical review of literature from the initial results and by searching The Cochrane Database of Systematic Reviews. All English‐language, peer‐reviewed publications identified were evaluated. Reviews, case studies and trials reporting anticoagulation response using an unconverted prothrombin time ratio were excluded. Results and Discussion:: Thirty‐one abstracts were initially reviewed, and seven studies were identified for inclusion in this review. Significant changes in mean INR post‐vaccination between the study and comparator groups were documented in one trial. Through subgroup analysis, another study noted that elderly patients spent more time in the subtherapeutic range post‐vaccination when compared with baseline INR levels. No other significant changes in mean INR levels were documented following influenza vaccination. Adverse bleeding events reported after immunization were limited and minor in nature. What is new and Conclusion:: Overall, our review does not indicate a consistent, clinically relevant effect of influenza vaccines on INR of patients on chronic warfarin therapy. Isolated reports of variations in INR following influenza vaccination are likely due to other factors.

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Section: Prospective Studies -Placebo Controlledmentioning

confidence: 99%

Effect of influenza vaccination on international normalized ratio during chronic warfarin therapy

Kuo

Brown

Clinard

2012

Journal of Clinical Pharmacy and Therapeutics

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“…Nevertheless, previous small studies have shown that i.m. injection in an aqueous vehicle can be administered safely to patients receiving anticoagulant medications without increased risk of local bleeding (32,33,34,35,36); however, the use of larger volume of oil vehicle may change such risks. This study, based on self-report, did not record any instance of post-injection haematoma, allowing us to establish plausible upper 95% confidence limits on the risk of post-injection haematoma as 0.1% for all men having TU injections, 1% for men using anticoagulant or antiplatelet medication but who interrupt that medication temporarily for the TU injection and 5.4% for men continuing to use such medication at the time of TU injection.…”

Section: Discussionmentioning

confidence: 99%

Complications of injectable testosterone undecanoate in routine clinical practice

Middleton

Turner

Fennell

et al. 2015

European Journal of Endocrinology

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Objective: Injectable testosterone undecanoate (TU) was marketed within the last decade, but its complications in routine clinical practice are not well defined. Design and methods: Prospective observational study of consecutive TU injections in an Andrology Clinic to estimate the incidence of i) immediate cough/syncope due to pulmonary oil microembolisation (POME), ii) post-injection haematoma and iii) the prevalence of secondary polycythaemia. Results: In 3022 injections given to 347 patients over 3.5 years, POME was observed after 56 injections (66% mild, 19% severe; 40% with onset before injection completed) in 43 patients. The incidence of 19 (95% CI 14-24) per 1000 injections did not differ between three experienced nurse injectors, but recurrences were more frequent than by chance. No post-injection haematoma was reported including after 269 injections to men taking antiplatelet, anticoagulant or both drugs (upper 95% confidence limit 1%) with 56 not withholding drugs prior to TU administration (upper 95% confidence limit 5.4%). Mean haematocrit was 0.44G0.04 (S.D.) with 25 (7%) O0.50, 14 (4%) O0.52 and 3 (1%) O0.54. Conclusion: TU injections produce a low incidence of POME with injections by experienced nurses, but recurrence is more frequent than by chance. Post-injection haematoma was not observed even among men using anticoagulant and/or antiplatelet drugs, and polycythaemia was a minor problem rarely requiring treatment other than optimising inter-injection interval.

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“…Anticoagulated individuals may be assumed to bleed more when receiving pre-travel vaccinations; however, an RCT in Spain involving 229 patients showed that intramuscular injection of the influenza vaccine did not result in more bleeding than the subcutaneous route. 58 Medical Devices and Automated External Defibrillators Literature on implanted cardiac devices in relation to international travel is sparse. These devices, like permanent pacemakers and implanted cardioverter-defibrillators, may add complexity when passing through airport security checkpoints.…”

Section: Medical Tourismmentioning

confidence: 99%

Pre-travel Health Advice for Patients With Cardiovascular Disease

Liew

Flaherty

2019

Int J Travel Med Glob Health

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Cardiovascular disease (CVD) is the leading cause of death among international travellers. Practitioner knowledge of the effects of CVD on international travel is imperative in order to promote a healthy travel experience. This review aimed to explore the available literature on this topic. The PubMed database was accessed to source relevant literature using combinations of relevant keywords as search terms. Articles were restricted to those published in the English language through March 2019. Of 1726 article records retrieved, 73 relevant papers were examined carefully. The results of this narrative review are related to multiple aspects of CVD and travel. The pre-travel consultation should address issues regarding vaccinations, travel insurance, anticoagulation, and medical devices. Additional vaccines to be discussed include influenza, pneumococcal, and hepatitis B. Patients with CVD should be advised of the need to carry a copy of their ECG, prescription(s), and pacemaker manufacturer’s card. Knowledge of the location overseas of automated external defibrillators and awareness of health risks associated with strenuous adventure activities are important for CVD travellers. Medical tourism for patients with CVD is briefly considered. Space tourism is an emerging category of extreme international travel that requires specialized pre-travel preparation. This narrative review article highlights the gaps in the travel medicine literature in relation to CVD. A strong evidence base for most recommendations is lacking. Future scholarly efforts are warranted to facilitate more robust travel recommendations for CVD patients. No qualitative studies to date have described the experiences of international travellers with CVD.

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Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

Cited by 29 publications

References 7 publications

Effect of influenza vaccination on international normalized ratio during chronic warfarin therapy

Effect of influenza vaccination on international normalized ratio during chronic warfarin therapy

Complications of injectable testosterone undecanoate in routine clinical practice

Pre-travel Health Advice for Patients With Cardiovascular Disease

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