2296. Hypoglycemia Risk with Antibiotics: An Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)

Abstract Background In July of 2018, the FDA published a drug safety warning for the potential risk of developing hypoglycemia with fluoroquinolones. Some studies have evaluated the potential risk of developing hypoglycemia with linezolid and tigecycline. A few case reports have also been published that report hypoglycemia from cefditoren, doxycycline, and trimethoprim-sulfamethoxazole use. Since data comparing various antibiotics and the risk of developing hypoglycemia is limited, the objective of this study was to evaluate the association between hypoglycemia and antibiotics using the FDA Adverse Event Reporting Systems (FAERS). Methods FAERS reports from January 1, 2004 to December 31, 2017 were included in the study. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify cases of hypoglycemia. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and hypoglycemia were calculated. An association was considered to be statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 2,334,959 reports (including 18,466 hypoglycemia reports) were considered, after inclusion criteria were applied. Cefditoren had the greatest proportion of hypoglycemia reports, representing 10% of all cefditoren reports. Statistically significant hypoglycemia RORs (95% CI) for antibiotics were: cefditoren 14.03 (8.93–22.03), tigecycline 3.32 (1.95–5.65), clarithromycin 2.41 (1.89–3.08), ertapenem 2.07 (1.14–3.75), moxifloxacin 2.06 (1.59–2.65), levofloxacin 1.66 (1.37–2.01), linezolid 1.54 (1.07–2.20). Conclusion Cefditoren, tigecycline, clarithromycin, ertapenem, moxifloxacin, levofloxacin, and linezolid were all significantly associated with hypoglycemia. The ertapenem association had not been reported in prior literature. Levofloxacin and moxifloxacin were the only fluoroquinolones significantly associated with hypoglycemia, even though the FDA drug safety warning was issued for all fluoroquinolones. Doxycycline and trimethoprim-sulfamethoxazole were not significantly associated with hypoglycemia, even though case reports have reported hypoglycemia with doxycycline and trimethoprim-sulfamethoxazole. Disclosures All authors: No reported disclosures.

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Estimated Incidence of Sugammadex-Induced Anaphylaxis Using the Korea Adverse Event Reporting System Database

Journal of Clinical Medicine ◽

10.3390/jcm10153202 ◽

2021 ◽

Vol 10 (15) ◽

pp. 3202

Author(s):

Jae-Woo Ju ◽

Nayoung Kim ◽

Seong Mi Yang ◽

Won Ho Kim ◽

Ho-Jin Lee

Keyword(s):

Risk Management ◽

Adverse Event ◽

General Anesthesia ◽

Drug Safety ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Sales Volume ◽

Event Reporting ◽

Pharmacovigilance Database

We aimed to investigate the incidence of sugammadex-induced anaphylaxis in a large Korean population. We retrospectively investigated the incidence of sugammadex-induced anaphylaxis between 2013 and 2019 from the database of the Korea Institute of Drug Safety-Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS). We estimated the incidence of sugammadex-induced anaphylaxis from the KIDS-KAERS database, assuming that the reporting efficiency was 10%, 50%, and 100%, respectively. We also investigated its annual sales volume in Korea and assumed that the exposure to sugammadex was 95% of the estimated sales volume. During the study period, 1,401,630 sugammadex vials were sold, and 19 cases of sugammadex-induced anaphylaxis were identified in the KIDS-KAERS database. The estimated incidence of sugammadex-induced anaphylaxis was 0.0143%, 0.00279%, and 0.0014%, assuming a reporting efficiency of 10%, 50%, and 100%, respectively. All patients, except for one with a missing record, fully recovered after anaphylaxis. The incidence of sugammadex-induced anaphylaxis identified in the national pharmacovigilance database was lower than previously reported rates in other countries. Therefore, its use in general anesthesia should not be hindered by concerns about the resulting risk of anaphylaxis in Korea.

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Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

BMC Bioinformatics ◽

10.1186/1471-2105-15-17 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 34

Author(s):

Rong Xu ◽

QuanQiu Wang

Keyword(s):

Adverse Event ◽

Drug Safety ◽

Large Scale ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Biomedical Literature ◽

Safety Signal ◽

Event Reporting ◽

Post Marketing

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Comparison of Rhabdomyolysis Associated With Sacubitril/valsartan-related Drug-drug Interactions by Individual Statins in an Adverse Event Reporting System

10.21203/rs.3.rs-265192/v1 ◽

2021 ◽

Author(s):

Tomiko Sunaga ◽

Ryo Yonezawa

Keyword(s):

Adverse Event ◽

Drug Interactions ◽

Reporting System ◽

Case Reports ◽

Organic Anion ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Event Reporting ◽

Structured Analysis

Abstract BackgroundSacubitril/valsartan was approved in Japan recently. Sacubitril is an inhibitor of organic anion-transporting polypeptide (OATP) 1B1 and 1B3. In Japan, sacubitril/valsartan product labeling indicates that it should be cautiously co-administered with atorvastatin due to drug-drug interactions (DDIs). However, all statins are the substrates of OATP1B1 and/or 1B3. Therefore, we should be cautious about DDIs between sacubitril/valsartan and all other statins.ObjectiveTo evaluate the association between rhabdomyolysis and concomitant association of sacubitril/valsartan with atorvastatin and all other statins.MethodsCase reports from the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) from 2015 to Q4/2020 were used. All FAERS reports on sacubitril/valsartan were captured through a structured analysis. We compared the proportion of cases reporting the adverse events associated with rhabdomyolysis and the concomitant use of sacubitril/valsartan and atorvastatin to those with sacubitril/valsartan and all other statins.ResultsAmong 10,940 case reports on sacubitril/valsartan, compared with all other drugs, statin users were associated with increased rhabdomyolysis (reporting odds ratio =4.54[2.62-7.87]). However, compared with all other statins, atorvastatin was not associated with increased rhabdomyolysis. ConclusionsWe suggest that the co-administration of sacubitril/valsartan with atorvastatin as well as other statins should be carefully managed as it may induce rhabdomyolysis.

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Hypoglycemia Associated with Direct Acting Anti‐hepatitis C Virus Drugs: an Epidemiologic Surveillance Study of the FDA Adverse Event Reporting System (FAERS)

Clinical Endocrinology ◽

10.1111/cen.14660 ◽

2021 ◽

Author(s):

Yu Zhou ◽

Wenhuo Xie ◽

Chenhua Zheng ◽

Libin Liu ◽

Zhou Chen ◽

...

Keyword(s):

Adverse Event ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Surveillance Study ◽

Event Reporting ◽

Epidemiologic Surveillance ◽

Direct Acting

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Counterfeit Epoetin: A Review of MedWatch Data.

Blood ◽

10.1182/blood.v106.11.2251.2251 ◽

2005 ◽

Vol 106 (11) ◽

pp. 2251-2251

Author(s):

Dennis W. Raisch ◽

Charles L. Bennett ◽

Jonathan Nebeker ◽

Rita Jakiche ◽

Ken Carson

Keyword(s):

Adverse Event ◽

Reporting System ◽

Drug Effect ◽

Case Reports ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Pharmaceutical Product ◽

Counterfeit Drugs ◽

Event Reporting ◽

Product Counterfeit

Abstract Introduction: In 2002 and 2003, Ortho Biotech Products, L.P. issued “Dear Health Professional” letters describing two distinct episodes with distribution of counterfeit epoetin (ProcritÒ). The first episode in 2002 occurred when counterfeit labels marked as “40,000 Unit” vials were switched onto 2,000 Unit Procrit vials (5% potency). An estimated 97,000 vials of this product were not recovered, as many as 25,000 patients may have been exposed. A second episode occurred in 2003 when bacteria-contaminated tap water was added to vials that were labeled as containing “40,000 Units” of Procrit®. The “Dear Doctor” letters describe the subtle labeling and other product packaging features that distinguish the products from authentic. In addition, specific lot numbers are identified. We reviewed all MedWatch reports from the United States’ Food and Drug Administration (FDA) for confirmed or possible cases of counterfeit epoetin. Methods: For the years 1998 to 2004, the FDA’s adverse event reporting system (AERS) was searched, using key words: “suspected product tampering,” “decreased drug effect” and related terms, and all epoetin product names. We summarized the demographic variables for the cases and identified the lot numbers reported within the cases. Results: Seven cases of “medication tampering” were identified in the FDA’s Adverse Event Reporting System (AERS) database - all 7 included Procrit® lot numbers identified in the “Dear Health Professional” Warning Letters from OrthoBiotech. The cases had been reported to the FDA by pharmacists (n=5), a consumer (n=1), and a nurse (n=1). In six of these case reports, among cancer patients, death also listed on the report, although counterfeit product was not listed as the proximate cause of death. There were no case reports identified by the diagnostic term of “pharmaceutical product counterfeit”, which was added to the FDA’s AERS in 2004. We identified an additional 643 cases of MedWatch cases that were coded with the diagnostic labels of “drug ineffective”, “therapeutic response decreased”, “drug effect decreased”, “condition aggravated”, and similar terms. The mean age equal to 59.7± 17.7 years, range 5–95 years. There were 269 females (42%) and 358 males (55%), gender not reported for 3%. All epoietin products were included. Finally, one case was found with a reported lot number corresponding to one listed in the warning letters. Death occurred in this 89 year-old patient. Conclusion: Health professionals should be alert for potential counterfeit drugs whenever drug effects are less than expected and the pharmaceutical is costly. Whenever suspected, the occurrences should be reported to the FDA and the manufacturer as possible “pharmaceutical product counterfeit.” The use of radio frequency identification (RFID), planned to be implemented in 2007 may help prevent the domestic distribution of counterfeit drugs, but increases in direct importation of drugs from international sources will potentially increase the likelihood of distribution of counterfeit drugs domestically.

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