Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
Abstract
:1. Introduction
2. Results
2.1. Analysis of the complete Data set
2.2. Characterization of Suspected Serious ADR
2.3. System Organ Class Level
3. Discussion
4. Materials and Methods
4.1. Data Source and Definition Dataset
4.2. Statistical Analysis
Author Contributions
Funding
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Amoxicillin | Amoxicillin + Clavulanic Acid | Azithromycin | Cefazolin | Ciprofloxacin | Clarithromycin | Levofloxacin | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total (%) | Serious (%) | Total (%) | Serious | Total (%) | Serious (%) | Total (%) | Serious (%) | Total (%) | Serious (%) | Total (%) | Serious (%) | Total (%) | Serious (%) | Total (%) | Serious (%) | ||
Year | 2017 | 3180 (19) | 2329 (18) | 4406 (26) | 3069 (24) | 1120 (7) | 853 (7) | 580 (3) | 458 (4) | 2777 | 2153 (17) | 1601 (9) | 1188 (9) | 3239 (19) | 2674 (21) | 16,903 (29) | 12,724 (33) |
2018 | 4041 (22) | 1981 (19) | 5242 (29) | 3069 (29) | 1247 (7) | 641 (6) | 466 (3) | 335 (3) | 2963 | 1709 (16) | 1666 (9) | 855 (8) | 2740 (15) | 1891 (18) | 18,365 (31) | 10,481 (28) | |
2019 | 5115 (22) | 2772 (19) | 5867 (25) | 3418 (23) | 1711 (7) | 1011 (7) | 544 (2) | 414 (3) | 3606 | 2181 (15) | 1958 (8) | 1033 (7) | 4953 (21) | 3948 (27) | 23,754 (40) | 14,777 (39) | |
Total | 12,336 | 7082 | 15,515 | 9556 | 4078 | 2505 | 1590 | 1207 | 9346 | 6043 | 5225 | 3076 | 10,932 | 8513 | |||
Sex | Male | 4603 (19) | 2639 (17) | 6228 (26) | 3891 (25) | 1492 (6) | 994 (6) | 704 (3) | 525 (3) | 4083 (17) | 2640 (17) | 1743 (7) | 1087 (7) | 5036 (21) | 3919 (25) | 23,889 (40) | 15,695 (41) |
Female | 7218 (22) | 4013 (20) | 8322 (29) | 4856 (24) | 2396 (7) | 1355 (7) | 848 (3) | 649 (3) | 4933 (15) | 3147 (16) | 3230 (10) | 1790 (9) | 5257 (16) | 4014 (20) | 32,204 (55) | 19,824 (52) | |
Not specified | 515 (18) | 430 (17) | 965 (25) | 809 (33) | 190 (6) | 156 (6) | 38 (1) | 33 (1) | 330 (11) | 256 (10) | 252 (9) | 199 (8) | 639 (22) | 580 (24) | 2929 (5) | 2463 (6) | |
Age Group | 0–1 month | 22 (26) | 18 (28) | 26 (31) | 18 (28) | 19 (23) | 16 (25) | 5 (6) | 4 (6) | 5 (6) | 3 (5) | 4 (5) | 2 | 3 (4) | 3 (5) | 84 (0) | 64 (0) |
2 months–2 years | 848 (44) | 324 (38) | 661 (35) | 289 (34) | 215 (11) | 149 (17) | 15 (1) | 9 (1) | 38 (2) | 23 (3) | 116 (6) | 47 | 19 (1) | 16 (2) | 1912 (3) | 857 (2) | |
3–11 years | 952 (35) | 413 (29) | 921 (34) | 463 (33) | 379 (14) | 245 (17) | 33 (1) | 19 (1) | 106 (4) | 82 (6) | 279 (10) | 153 | 46 (2) | 43 (3) | 2716 (5) | 1418 (4) | |
12–17 years | 390 (28) | 216 (26) | 421 (31) | 246 (29) | 139 (10) | 80 (9) | 48 (4) | 35 (4) | 116 (8) | 84 (10) | 120 (9) | 74 | 136 (10) | 108 (13) | 1370 (2) | 843 (2) | |
18–64 years | 5627 (20) | 3307 (18) | 7481 (27) | 4584 (25) | 1879 (7) | 1074 (6) | 826 (3) | 626 (3) | 4760 (17) | 3059 (17) | 2507 (9) | 1413 | 5055 (3592) | 3966 (22) | 28,135 (48) | 18,029 (47) | |
65–85 years | 2372 (17) | 1429 (15) | 3303 (23) | 2119 (22) | 687 (5) | 437 (5) | 499 (3) | 385 (4) | 2645 (18) | 1763 (18) | 1212 (8) | 789 | 3592 (25) | 2713 (28) | 14,310 (24) | 9635 (25) | |
More than 85 | 499 (16) | 326 (15) | 967 (31) | 642 (29) | 108 (3) | 83 (4) | 68 (2) | 45 (2) | 518 (16) | 370 (17) | 200 (6) | 139 | 798 (25) | 606 (27) | 31,58 (5) | 2211 (6) | |
Not specified | 1626 (22) | 1049 (21) | 1735 (24) | 1195 (24) | 652 (9) | 421 (9) | 96 (1) | 84 (2) | 1158 (16) | 659 (13) | 787 | 459 | 1283 (17) | 1058 (21) | 7337 (12) | 4925 (13) | |
Reporter group | Health professional | 10,152 (21) | 6444 (19) | 13,422 (28) | 8765 (26) | 2929 (6) | 2026 (6) | 1563 (3) | 1188 (4) | 6648 (14) | 4577 (14) | 3857 (8) | 2581 (8) | 9609 (20) | 606 (27) | 48180 (68) | 33,350 (88) |
Other | 2184 (20) | 20 | 2093 (19) | 19 | 1149 (11) | 11 | 27 (0) | 0 | 2698 (25) | 25 | 1368 (13) | 13 | 1323 (12) | 1058 (21) | 10,842 (32) | 4638 (12) | |
Geographic origin | EEA | 9552 (24) | 4368 (23) | 11495 (29) | 5571 (29) | 2390 (6) | 852 (4) | 1055 (3) | 678 (4) | 6773 (17) | 3509 (18) | 3830 (10) | 1726 (9) | 4935 (12) | 2581 (13) | 40,030 | 19,285 (51) |
Non-EEA | 2784 (15) | 2714 (15) | 4020 (21) | 3985 (21) | 1688 (9) | 1653 (9) | 535 (3) | 529 (3) | 2573 (14) | 2534 (14) | 1395 (7) | 1350 (7) | 5997 (32) | 5932 (32) | 18,992 (32) | 18,697 (49) |
Age Group | Sex | ||||||||
---|---|---|---|---|---|---|---|---|---|
MedDRA SOCs | 0–1 Month (%) | 2 Months–2 Years (%) | 3–11 Years (%) | 12–17 Years (%) | 18–64 Years (%) | 65–85 Years (%) | More than 85 Years (%) | Male (%) | Female (%) |
Gastrointestinal disorders | 7 (0.1) | 242 (2.4) | 452 (4.5) | 280 (2.8) | 5989 (59.9) | 2614 (26.1) | 420 (4.2) | 4057 (8.7) | 6668 (10.7) |
General disorders and administration site conditions | 16 (0.1) | 233 (1.9) | 527 (4.3) | 294 (2.4) | 7454 (60.4) | 3314 (26.9) | 495 (4.0) | 5674 (12.1) | 7392 (11.9) |
Skin and subcutaneous tissue disorders | 13 (0.1) | 611 (3.7) | 1059 (6.4) | 516 (3.1) | 9290 (56.6) | 4034 (24.6) | 902 (5.5) | 7089 (15.2) | 9966 (16.0) |
General Disorders and Administration Site Conditions | General Disorders and Administration Site Conditions | Skin and Subcutaneous Tissue Disorders | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Preferred Term | Diarrhea | Nausea | Vomiting | Pyrexia | Drug Ineffective | Drug Interaction | Pruritus | Rash | Urticaria | Erythema | |
Active Substances | |||||||||||
Amoxicillin | 267 | 206 | 222 | 234 | 105 | 81 | 498 | 1060 | 538 | 256 | |
Amoxicillin + clavulanic acid | 619 | 309 | 466 | 353 | 295 | 80 | 626 | 1289 | 762 | 430 | |
azithromycin | 179 | 126 | 129 | 112 | 206 | 90 | 120 | 168 | 86 | 47 | |
cefazolin | 10 | 13 | 14 | 34 | 30 | 13 | 41 | 81 | 49 | 61 | |
ciprofloxacin | 305 | 319 | 173 | 215 | 299 | 242 | 218 | 344 | 143 | 149 | |
clarithromycin | 207 | 200 | 165 | 126 | 140 | 298 | 99 | 164 | 95 | 80 | |
levofloxacin | 203 | 265 | 261 | 293 | 220 | 154 | 390 | 551 | 202 | 178 |
Death (%) | Life-Threatening (%) | Hospitalization (Initial or Prolonged) (%) | Persistent or Significant Disability or Incapacity (%) | Congenital Anomaly (%) | Medically Important Event or Reaction (%) | ||
---|---|---|---|---|---|---|---|
Amoxicillin | 126 (1.8) | 490 (6.9) | 2495 (35.2) | 64 (0.9) | 13 (0.2) | 3894 (55.0) | |
Amoxicillin + Clavulanic acid | 358 (3.7) | 711 (7.4) | 3464 (36.2) | 101 (1.1) | 8 (0.1) | 4914 (51.4) | |
Azithromycin | 128 (5.1) | 134 (5.3) | 869 (34.7) | 56 (2.2) | 7 (0.3) | 1311 (52.3) | |
Cefazoline | 62 (5.1) | 332 (27.5) | 419 (34.7) | 3 (0.2) | 1 (0.1) | 390 (32.3) | |
Ciprofloxacin | 287 (4.7) | 360 (6.0) | 2152 (35.6) | 487 (8.1) | 5 (0.1) | 2752 (45.5) | |
Clarithromycin | 127 (4.1) | 168 (5.5) | 1091 (35.5) | 83 (2.7) | 3 (0.1) | 1604 (52.1) | |
Levofloxacin | 632 (7.4) | 621 (7.3) | 3249 (38.2) | 491 (5.8) | 3 (0.0) | 3517 (41.3) | |
Age groups | 0–1 month | 6 (9) | 8 (12) | 21 (33) | 2 (3) | 1 (2) | 26 (4) |
2 months–2 years | 23 (3) | 30 (4) | 305 (36) | 8 (12) | 9 (1) | 487 (57) | |
3–11 years | 33 (2) | 77 (5) | 499 (35) | 15 (1) | 6 (0) | 788 (56) | |
12–17 years | 17 (2) | 72 (9) | 330 (39) | 14 (2) | 0 (0) | 410 (49) | |
18–64 years | 776 (4) | 1556 (9) | 6259 (35) | 701 (4) | 6 (0) | 8731 (48) | |
65–85 years | 548 (6) | 806 (8) | 4349 (45) | 375 (4) | 0 (0) | 3557 (37) | |
More than 85 | 161 (7) | 137 (6) | 119 (54) | 58(3) | 3(0) | 660 (30) | |
SEX | Female | 698 (3.5) | 1483 (7.5) | 1277 (8.1) | 691 (3.5) | 14 (0.1) | 9806 (49.5) |
Male | 938 (6) | 556 (3.5) | 6242 (39.8) | 556 (3.5) | 16 (0.1) | 6666 (42.5) |
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Ferreira, J.; Placido, A.I.; Afreixo, V.; Ribeiro-Vaz, I.; Roque, F.; Herdeiro, M.T. Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections. Antibiotics 2022, 11, 477. https://doi.org/10.3390/antibiotics11040477
Ferreira J, Placido AI, Afreixo V, Ribeiro-Vaz I, Roque F, Herdeiro MT. Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections. Antibiotics. 2022; 11(4):477. https://doi.org/10.3390/antibiotics11040477
Chicago/Turabian StyleFerreira, Joana, Ana Isabel Placido, Vera Afreixo, Inês Ribeiro-Vaz, Fátima Roque, and Maria Teresa Herdeiro. 2022. "Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections" Antibiotics 11, no. 4: 477. https://doi.org/10.3390/antibiotics11040477