Buying Over-the-Counter Antacid Products Containing Aspirin? FDA Drug Safety Communication for Serious Bleeding Risk

2017 ◽  
Vol 112 (4) ◽  
pp. 654-655
Author(s):  
Kiran Kumar Boyina ◽  
Gayatri Nakkana ◽  
Venkata Ramana V Murthy
Keyword(s):  
Drug Safety ◽  
Bleeding Risk ◽  
Safety Communication ◽  
Over The Counter

Impact of a drug safety communication on the severity of benzonatate exposures reported to poison centers

2020 ◽  
Vol 30 (1) ◽  
pp. 45-52
Author(s):  
James B. Leonard ◽  
Hyunuk Seung ◽  
Wendy Klein‐Schwartz
Keyword(s):  
Drug Safety ◽  
Safety Communication ◽  
Poison Centers

scholarly journals Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

2018 ◽  
Vol 26 (2) ◽  
pp. 238-243 ◽  
Author(s):  
Bander Balkhi ◽  
Enrique Seoane-Vazquez ◽  
Rosa Rodriguez-Monguio
Keyword(s):  
Drug Safety ◽  
Safety Communication

Effect of Over the Counter Ibuprofen Dosing after Sinus Surgery for Chronic Rhinosinusitis: A Prospective Cohort Pilot Study

2020 ◽  
Vol 129 (7) ◽  
pp. 677-683
Author(s):  
Craig Miller ◽  
Ian M. Humphreys ◽  
Greg E. Davis
Keyword(s):  
Pilot Study ◽  
Prospective Cohort ◽  
Postoperative Bleeding ◽  
Bleeding Risk ◽  
Sinus Surgery ◽  
Level Of Evidence ◽  
Over The Counter ◽  
Bleeding Rate ◽  
Significant Difference ◽  
Opioid Medications

Introduction: Management of pain following endoscopic sinus surgery (ESS) often involves intermittent use of opioid medications. Given the current opioid crisis, many surgeons aim to minimize opioid prescriptions. However, surgeons often avoid the use of NSAIDs following ESS out of concern for increased bleeding risk. We sought to evaluate the effectiveness and safety of over the counter dosing of ibuprofen on pain and bleeding rates following ESS. Methods: Prospective cohort pilot study of patients undergoing ESS. Patients self-selected either control arm (acetaminophen and PRN oxycodone) or intervention arm (alternating ibuprofen with acetaminophen, and PRN oxycodone). Outcome measures included pain (10-point visual analog scale [VAS]), bleeding rate (10-point VAS), and number of opiate pills consumed. Results: Thirty-nine patients completed the study (15 control and 24 intervention). Overall, patients in the intervention arm reported decreased pain levels at days 1 (−0.9 [95%CI: −2.2, 0.5], 3 (−0.9 [95%CI: −2.3, 0.5]), and 7 (−0.6 [95%CI: −1.8, 0.6]), as well as decreased postoperative bleeding at those same days −0.9 [95%CI: −2.1, 0.4], −0.9 [95%CI: −2.1, 0.4], and −0.7 [95% CI: −1.2, −0.7], compared to controls. Opiate consumption was similar between groups with patients consuming on average four opiate pills (oxycodone 5 mg). Conclusions: Over the counter dosing of ibuprofen along with acetaminophen may yield better pain control after sinus surgery compared to acetaminophen alone. Additionally, there was no significant difference in epistaxis in the ibuprofen cohort compared to the cohort who did not take ibuprofen. Furthermore, this study showed very few opioid pills were consumed after routine ESS regardless of pain regimen prescribed. A larger trial is needed to make definitive statements on safety and efficacy. Level of Evidence: 2b

scholarly journals Correction to: Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

Drug Safety ◽  
2020 ◽  
Vol 43 (8) ◽  
pp. 827-829
Author(s):  
Sieta T. de Vries ◽  
◽  
Maartje J. M. van der Sar ◽  
Anna Marie Coleman ◽  
Yvette Escudero ◽  
...  
Keyword(s):  
Drug Safety ◽  
Healthcare Professionals ◽  
Survey Study ◽  
Specific Drug ◽  
Communication Tools ◽  
Safety Communication ◽  
Safety Issues

scholarly journals Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis

2018 ◽  
Vol 4 (1) ◽  
pp. e1 ◽  
Author(s):  
Michael S Sinha ◽  
Clark C Freifeld ◽  
John S Brownstein ◽  
Macarius M Donneyong ◽  
Paula Rausch ◽  
...  
Keyword(s):  
Social Media ◽  
Mixed Methods ◽  
Drug Safety ◽  
Safety Communication ◽  
Media Impact

scholarly journals Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

Drug Safety ◽  
2018 ◽  
Vol 41 (7) ◽  
pp. 713-724 ◽  
Author(s):  
Sieta T. de Vries ◽  
◽  
Maartje J. M. van der Sar ◽  
Anna Marie Coleman ◽  
Yvette Escudero ◽  
...  
Keyword(s):  
Drug Safety ◽  
Healthcare Professionals ◽  
Survey Study ◽  
Specific Drug ◽  
Communication Tools ◽  
Safety Communication ◽  
Safety Issues

Changes in Long-acting β-agonist Utilization After the FDA’s 2010 Drug Safety Communication

2015 ◽  
Vol 37 (1) ◽  
pp. 114-123.e1 ◽  
Author(s):  
Daniel M. Hartung ◽  
Luke Middleton ◽  
Sheila Markwardt ◽  
Kaylee Williamson ◽  
Kathy Ketchum
Keyword(s):  
Drug Safety ◽  
Safety Communication ◽  
Long Acting

scholarly journals Impact of a US Food and Drug Administration Drug Safety Communication on Zolpidem Dosing

2015 ◽  
Author(s):  
Jonathan L. Harward ◽  
Valerie B. Clinard ◽  
Michael R. Jiroutek ◽  
Beverly H. Lingerfeldt ◽  
Andrew J. Muzyk
Keyword(s):  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Safety Communication
Sign in / Sign up

Export Citation Format

Share Document