Abstract
Background
Cefazolin is the most effective prophylactic antibiotic for orthopedic surgeries. There is a high prevalence of patient-reported beta-lactam antibiotic allergies, which often results in inferior pre-operative antibiotics use. This study's purpose was to determine the rate of true allergic reactions among patients with a reported beta-lactam allergy when administered cefazolin. The hypothesis was that the rate of true allergic reactions would be low following cefazolin administration among patients with reported beta-lactam allergy.
Methods
Patients undergoing orthopedic surgical procedures by a single surgeon between January 2023 and December 2024 were included. Reported autoimmune/psychiatric disorders, total number of reported allergies, type of reported beta-lactam antibiotic allergy, reported symptoms to beta-lactam antibiotic, and reported allergy severity were obtained via electronic medical records. Allergies were categorized as “true allergies” (anaphylactic/non-anaphylactic) or “other reactions.” Demographic and allergy characteristics were compared between patients who did and did not report a beta-lactam antibiotic allergy.
Results
Of 1,603 patients (57 ± 18 years; 47% female), 310 (19%) patients reported a beta-lactam antibiotic allergy and 230/310 (74%) specifically reported a penicillin allergy. Female (61% vs. 44%, P < .001) and older patients (60 ± 16 vs. 57 ± 18 years, P = .002) were more likely to report beta-lactam allergies. Of the 310 patients with a reported beta-lactam antibiotic allergy, 18 (6%) patients reported anaphylaxis, 224 (72%) non-anaphylactic reaction, and 100 (32%) reported other reaction type. Of patients with a reported beta-lactam antibiotic allergy, 301 (97%) patients were administered cefazolin during surgery, and 0 patients were found to have a true allergic reaction.
Conclusion
Zero patients with a reported beta-lactam antibiotic allergy were found to have a true allergic reaction during the intraoperative or immediate post-operative period following cefazolin administration during an orthopedic surgery. Although reported allergies should be critically evaluated, this suggests cefazolin may be safely administered even if a beta-lactam antibiotic allergy is reported.
Keywords: Beta-lactam allergy, Penicillin allergy, Cefazolin, Ancef, Infection prophylaxis, Post-operative infection
Surgical site infection (SSI) after orthopedic surgery occurs at a rate of 2.8% in the overall orthopedic population.12 Utilizing prophylactic antibiotics prior to surgical incision is vital to decrease this risk.4 According to the Infectious Disease Society of America, cefazolin is considered the drug of choice for prophylactic use in most orthopedic surgeries.4 Cefazolin has consistently shown to be superior because of its duration of action, spectrum of coverage, reasonable cost, favorable safety profile, and efficacy in preventing SSIs.4,11,15
Approximately 10-15% of the adult population worldwide is estimated to have either a self-reported or documented beta-lactam allergy.6 Beta-lactam antibiotics include penicillin, cefazolin, and amoxicillin, among others. However, most of these reported allergies are unverified, with the majority not being true immunoglobin-E-mediated allergic reactions.6
Patients with a recorded allergy to beta-lactam antibiotics are frequently given alternative antibiotics for surgical prophylaxis even when the documented allergy is for beta-lactams other than cefazolin.17,21 These alternative antibiotics are less effective in preventing SSIs, increasing the patients' risk of an adverse outcome following orthopedic surgeries.2,17,21 Multiple studies demonstrate that patients deemed allergic to beta-lactam antibiotics have a higher risk of SSIs after orthopedic surgeries, with this increased risk directly relating to alternative antibiotics use.2,9,17,21,27
While historically the Food and Drug Administration states that cross-reactivity between penicillin and cefazolin may occur in up to 10% of patients,16 recent studies have found the true cross-reactivity between penicillin and cephalosporin antibiotics to be less than 2%, with 1 meta-analysis reporting the cross-reactivity between penicillin and cefazolin to be as low as 0.7%.22,23
Furthermore, patients' ability to identify true allergic reactions, in addition to workflow and documentation issues, often perpetuates the use of alternative, less effective antibiotics.2,21 Thus, determining the prevalence of true allergic reactions to beta-lactam antibiotics in patients with reported allergies can help surgeons better determine the appropriate antibiotic to use in orthopedic surgeries.
The aim of the present study was to determine the rate of true allergic reactions among patients with a reported beta-lactam allergy who were administered cefazolin prophylactically before elective orthopedic surgeries. The hypothesis was that the rate of true allergic reactions to administered cefazolin would be low in patients with a reported beta-lactam allergy.
Materials and methods
Institutional review board approval was obtained from the University of Pittsburgh (No. STUDY20030061). This was a retrospective cohort study of consecutive patients who underwent an orthopedic surgical procedure by the senior author between January 2023 and December 2024. There were no other exclusion criteria. The electronic medical record system was reviewed to determine patient demographics, reported autoimmune/psychiatric disorders, total number of reported allergies, type of reported beta-lactam antibiotic allergy, reported reaction symptoms, and reported severity of beta-lactam antibiotic allergy. The reported severity of a beta-lactam antibiotic allergy was categorized as “anaphylactic,” “non-anaphylactic,” and “other non-allergic reactions.” Anaphylactic reactions were defined as an acute-onset, systemic, life-threatening reaction.18 Non-anaphylactic reactions included rash, swelling, itching, chest tightness, shortness of breath, syncope, and fever. Other non-allergic reactions included undocumented/unclear, yeast infection, family reported, or reported intolerance/ineffectiveness. Allergies were categorized as “true allergic reaction” (anaphylactic or non-anaphylactic) or “other reactions”.
Psychiatric disorders included anxiety, depression, obsessive compulsive disorder, schizophrenia, attention deficit hyperactivity disorder, and attention deficit disorder. Among included patients, autoimmune disorders included lupus erythematosus, celiac disease, Crohn disease, Hashimoto disease, autoimmune hypothyroidism, and autoimmune hepatitis.
Antibiotic allergies were evaluated by the nurses, anesthesia, and surgical team prior to surgery. The final prophylactic antibiotic decision was made by the operating surgeon.
Statistical analysis
All statistical analyses were performed in R statistical computing software (R version 4.5.0; R Foundation for Statistical Computing, Vienna, Austria). First, the prevalence of reported beta-lactam antibiotic allergies was reported and categorized as described above. Demographic characteristics, general allergy reporting rates, and rates of psychiatric/autoimmune diagnoses were compared between patients with and without a reported beta-lactam antibiotic allergy. Chi-square and Fisher exact test were used to compare rates of reported beta-lactam antibiotic allergies between patients with and without a psychiatric/autoimmune diagnosis. The Mann-Whitney U test compared the total number of reported allergies between patients with and without a psychiatric diagnosis. Statistical significance was set at P < .05.
Results
A total of 1,603 patients (mean age: 57 ± 18 years; 47% female) were included in this study (Table I). Among all included patients, 310 (19%) patients reported having an allergy to a beta-lactam antibiotic. The patients who were more likely to report a beta-lactam allergy were found to be female (61% vs. 44%, P < .001) and older (60 ± 16 vs. 57 ± 18 years, P = .002) than those who did not report a beta-lactam allergy. The average number of total reported allergies among the patients who reported a beta-lactam antibiotic allergy was significantly higher compared to patients without a reported beta-lactam antibiotic allergy (4 ± 4 vs. 2 ± 3, P < .001) (Table I).
Table I.
Patient demographics.
| Patient demographics | All patients (n = 1,603) | Patients with reported beta-lactam antibiotic allergy (n = 310) | Patients without reported beta-lactam antibiotic allergy (n = 1,293) | P value |
|---|---|---|---|---|
| Age, yr (mean ± SD) | 57 ± 18 | 60 ± 16 | 57 ± 18 | .002 |
| Sex, male (yes) (n, %) | 848, 53% | 121, 39% | 727, 56% | <.001 |
| Number of total reported allergies (mean ± SD) | 2.05 ± 3.0 | 4.04 ± 3.8 | 1.58 ± 2.6 | <.001 |
| Zero allergies (n, %) | 573, 36% | 0, 0% | 573, 44% | |
| 1 allergy (n, %) | 364, 23% | 86, 28% | 278, 22% | |
| 2-3 allergies (n, %) | 370, 23% | 96, 31% | 274, 21% | |
| 4-5 allergies (n, %) | 142, 9% | 51, 17% | 91, 7% | |
| 5+ allergies (n, %) | 154, 10% | 77, 25% | 77, 6% | |
| Psychiatric diagnosis (yes) (n, %) | 443, 28% | 84, 27% | 359, 28% | .805 |
| Autoimmune disorder (yes) (n, %) | 30, 2% | 8, 3% | 22, 2% | .304 |
N, number; SD, standard deviation.
There were no significant differences in reported psychiatric or autoimmune disorders between patients with or without a documented beta-lactam antibiotic allergy (Table I). However, the median number of reported allergens for those with a reported psychiatric disorder was 2 [interquartile range: 1-6], while the median number of reported allergens for those without a reported psychiatric disorder was 1 [interquartile range: 0-2] (P < .001).
Of the 310 patients with a reported beta-lactam antibiotic allergy, 230 (74%) reported penicillin as the allergen (Table II). The type of reaction is reported in Table III. Fifteen (5%) patients reported having an allergy to 2 or more types of beta-lactam antibiotics. Forty-four (14%) patients reported having 2 or more types of reactions to the documented beta-lactam allergy.
Table II.
Type of beta-lactam antibiotic causing allergic reaction.
| Beta-lactam antibiotic | Total (n = 310) |
|---|---|
| Penicillin, (n, %) | 230, 74% |
| Amoxicillin, (n, %) | 62, 20% |
| Cephalexin, (n, %) | 16, 5% |
| Ampicillin, (n, %) | 9, 3% |
| Amoxicillin + clavulanate potassium, (n, %) | 6, 2% |
| Cefazolin, (n, %) | 1, <1% |
| Oxacillin, (n, %) | 1, <1% |
| Piperacillin-tazobactam, (n, %) | 1, <1% |
GI, gastrointestinal; N, number.
Percentages based on 310 patients. Some patients reported allergic reactions to multiple beta-lactam antibiotics.
Table III.
Type and severity of reported allergic reaction.
| Type of allergic reaction | Total (n = 310) |
|---|---|
| Anaphylactic reaction (n, %) | 18, 6% |
| Non-anaphylactic reaction (n, %) | 224, 72% |
| Rash | 145, 47% |
| GI problems | 32, 10% |
| Swelling | 23, 7% |
| Itching | 9, 3% |
| Shortness of breath | 7, 2% |
| Syncope | 4, 1% |
| Chest tightness | 2, 1% |
| Fever | 2, 1% |
| Other Non-allergic reaction (n, %) | 100, 32% |
| Undocumented | 92, 30% |
| Yeast infection | 3, 1% |
| Family reported | 2, 1% |
| Intolerance | 2, 1% |
| Ineffective | 1, <1% |
N, number.
Percentages based on 310 patients. Some patients reported multiple allergic reactions.
Among the 310 patients with a reported beta-lactam antibiotic allergy, 301 (97%) were administered cefazolin intraoperatively. Zero patients had any type of reaction intraoperatively or immediately post-operatively. Alternative antibiotics for the remaining 9 (3%) patients were used based on the surgeon's decision to minimize workflow disruptions with anesthesia administration when an allergy to beta-lactam was flagged. One of the 9 (11%) patients reported an anaphylactic reaction to penicillin with the remaining 8 (89%) patients reporting other non-allergic reactions to either penicillin or amoxicillin. Of the 9 patients who received an alternative prophylactic antibiotic, 4 (44%) received ceftriaxone, 3 (33%) received vancomycin, and 2 (22%) received clindamycin. Among the 18 patients who had a documented anaphylactic beta-lactam antibiotic allergy, 17 (94%) received cefazolin intraoperatively of which none experienced a reaction. The remaining patient who documented an anaphylactic allergic reaction reported having an allergy to penicillin and received an alternative prophylactic antibiotic.
Discussion
Zero patients in the present study with a documented beta-lactam allergy, who were administered cefazolin prophylactically, were found to have a true allergic reaction to cefazolin intraoperatively or immediately post-operatively. Of note, of the patients who reported their reaction as anaphylactic, zero had a reaction to cefazolin. This supports the hypothesis that the actual rate of allergic reactions to cefazolin would be low in patients with reported beta-lactam allergies, particularly in patients flagged for a penicillin allergy. This finding also aligns with the American Academy of Allergy, Asthma, and Immunology recommendation that patients with history of anaphylactic reaction to penicillin may be routinely administered non-cross reactive cephalosporins, such as cefazolin.10
The present study is congruent with a study by Clarke et al5 who found that out of 521 patients, only 10 patients experienced a possible intraoperative allergic reaction to cefazolin, with no patients requiring epinephrine. In contrast with the present study, the study by Clark et al5 did not include a comparison group and excluded patients with reported cefazolin allergies. However, their conclusions still reinforce the findings of the present study, highlighting the safety and importance of cefazolin administration for SSI prophylaxis in beta-lactam allergic patients, even with a history of severe allergic reaction.5 Similarly, another study found only 1/241 patients required either the rapid response team or epinephrine intervention following cefazolin administration during total knee or hip arthroplasty.26 It was concluded that cefazolin use did not increase the risk of anaphylaxis, even in patients with a reported anaphylactic reaction to penicillin.26
Cefazolin's superiority has been emphasized by the American Board of Orthopaedic Surgery in the American Board of Orthopaedic Surgery Maintenance of Certification examination as the preferred orthopedic surgery prophylactic antibiotic.1,28 Due to cross-reactivity worry, patients with reported beta-lactam allergies are at a higher risk of infection because of alternative prophylactic antibiotics use.9,17,27 A previous study found prosthetic joint infection rates to increase within 1 year when using non–beta-lactam prophylaxis compared to beta-lactam prophylaxis such as cefazolin after total knee and shoulder arthroplasty.27 Similarly, another study found that patients who received cefazolin as the prophylactic antibiotic during a total shoulder arthroplasty had a significantly lower incidence of post-operative infection compared to patients who received a non-cefazolin antibiotic.9 A systematic review by Hanai et al7 with over 460,000 patients found that a reported beta-lactam antibiotic allergy was associated with a significantly higher risk for SSI and those receiving a beta-lactam antibiotic had a significantly lower risk of SSI compared to non–beta-lactam alternatives. This highlights the importance of cefazolin prophylaxis with avoidance of alternative antibiotics unless absolutely necessary.
The current study found females were more likely to report a beta-lactam antibiotic allergy. Prior studies concluded females are more likely to result in a positive penicillin skin testing reaction, with 1 study stating females are 10 times more likely to react to penicillin.14,19,25 When analyzing all antibiotic allergies, a study found the incidence and prevalence of antibiotic allergies to be higher for females, as well as the likelihood of self-reporting antibiotic allergies.14,24 However, an alternative study showed no significant difference between sexes regarding positive beta-lactam allergy results.20 The present study also found that, on average, patients who reported a beta-lactam allergy were 3 years older than patients without a reported beta-lactam allergy. While statistically significant, a 3-year age difference in a study population with an average of 57 years likely carries little clinical significance.
Interestingly, the present study found patients with a reported psychiatric disorder were more likely to report a higher total number of allergies. A previous retrospective study found that anxiety and depression were associated with multiple drug intolerance syndrome, and depression was associated with multiple drug allergy syndrome.3 A second study found that patients with multiple drug intolerance syndrome, defined as 3 or more unrelated drug class allergies, had higher rates of a new drug "allergy" incidence but not with an immunoglobulin-E-mediated allergy.13 This suggests that in patients with psychiatric comorbidities or extensive allergy histories, reported allergies may warrant clinical scrutiny to distinguish true allergic sensitivity from non-allergic intolerance or misattribution.
Changes in workflow and documentation may also be beneficial. Currently, allergic reactions are mostly documented as they are reported by the patient. This introduces the potential for recall bias, as well as the possibility that patients may describe reactions that are not consistent with true allergies, which in turn may lead to the use of second-line antibiotics. Prior studies have observed an increase in the use of first-line antibiotics following the implementation of antibiotic stewardship interventions and penicillin allergy screenings.8,21 Improving allergy documentation and antibiotic prophylaxis protocols may help lower post-operative orthopedic surgery infection rates.
This study has several limitations. First, the retrospective design restricts the analysis to information documented in the electronic medical record, which may be incomplete or inconsistently reported. Additionally, this study relies on patient-reported allergy histories, introducing the potential for recall bias. Patients may unintentionally over- or under-report both the presence and severity of their allergy. In the present study, the beta-lactam allergies reported were majority to penicillin which is distinct from other beta-lactam allergies, such as cefazolin, and should be treated as such.10 Further prospective studies, especially with larger cohorts of patients with a cephalosporin allergy, would help validate these findings and provide additional supporting data.
Conclusion
Zero patients with a reported beta-lactam antibiotic allergy were found to have a true allergic reaction during the intraoperative or immediate post-operative period following cefazolin administration during an orthopedic surgery. Although reported allergies should be critically evaluated, this suggests cefazolin may be safely administered even if a beta-lactam antibiotic allergy is reported.
Disclaimers:
Funding: No funding was disclosed by the authors.
Conflicts of interest: Albert Lin reports a paid consulting/advisory relationship with Arthrex and Stryker, is a board membership with Resto3d Inc., and holds intellectual property with Arthrex. Any additional authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
Footnotes
Institutional review board approval was obtained from the University of Pittsburgh (No. STUDY20030061).
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