Reporting of #Adverse Events in Published and #Unpublished Studies of Health Care Interventions: A Systematic Review

http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002127

Conclusions
There is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events.

#Adverse events associated with unblinded, but not with blinded, #statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31075-9/fulltext?elsca1=tlpr

These analyses illustrate the so-called #nocebo effect, with an excess rate of muscle-related AE reports only when patients and their doctors were aware that statin therapy was being used and not when its use was blinded. these results will help assure both physicians and patients that most AEs associated with statins are not causally related to use of the drug and should help counter the adverse effect on public health of exaggerated claims about statin-related side-effects.

Continued #Statin Prescriptions After #Adverse Reactions and Patient Outcomes: A Cohort Study
http://annals.org/aim/article/2645552/continued-statin-prescriptions-after-adverse-reactions-patient-outcomes-cohort-study

Many patients discontinue statin treatment, often after having a possible adverse reaction. The risks and benefits of continued statin therapy after an adverse reaction are not knownMany patients discontinue statin treatment, often after having a possible adverse reaction. The risks and benefits of continued statin therapy after an adverse reaction are not known Four years after the presumed adverse event, the cumulative incidence of the composite primary outcome was 12.2% for patients with continued statin prescriptions, compared with 13.9% for those without them (difference, 1.7% 95% CI, 0.8% to 2.7%; P < 0.001).

Conclusion:
Continued statin prescriptions after an adverse reaction were associated with a lower incidence of death and cardiovascular events.

#FDA improves access to reports of #adverse drug reactions
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578105.htm

The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.
"Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA," said FDA Commissioner Scott Gottlieb, M.D. "The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in."

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US Emergency Department Visits for #Adverse Drug Events From #Antibiotics in Children, 2011–2015

https://academic.oup.com/jpids/advance-article/doi/10.1093/jpids/piy066/5063274

Two-fifths (40.7%) of ED visits for antibiotic ADEs involved a child aged ≤2 years, and 86.1% involved an allergic reaction. Amoxicillin was the most commonly implicated antibiotic among children aged ≤9 years. When we accounted for dispensed prescriptions, the rates of ED visits for antibiotic ADEs declined with increasing age for all antibiotics except sulfamethoxazole-trimethoprim. Amoxicillin had the highest rate of ED visits for antibiotic ADEs among children aged ≤2 years, whereas sulfamethoxazole-trimethoprim resulted in the highest rate among children aged 10 to 19 years (29.9 and 24.2 ED visits per 10000 dispensed prescriptions, respectively).

Conclusions
Antibiotic ADEs lead to many ED visits, particularly among young children. Communicating the risks of antibiotic ADEs could help reduce unnecessary prescribing. Prevention efforts could target pediatric patients who are at the greatest risk of harm

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Association of Duration and Type of Surgical #Prophylaxis With Antimicrobial-Associated #Adverse Events

https://jamanetwork.com/journals/jamasurgery/article-abstract/2731307

The benefits of antimicrobial prophylaxis are limited to the first 24 hours postoperatively. Little is known about the harms associated with continuing antimicrobial prophylaxis after skin closure.

Adjusted odds of AKI increased with each additional day of prophylaxis (cardiac procedure: 24-<48 hours: adjusted odds ratio [aOR], 1.03; 95% CI, 0.95-1.12; 48-<72 hours: aOR, 1.22; 95% CI, 1.08-1.39; ≥72 hours: aOR, 1.82; 95% CI, 1.54-2.16; noncardiac procedure: 24-<48 hours: aOR, 1.31; 95% CI, 1.21-1.42; 48-<72 hours: aOR, 1.72; 95% CI, 1.47-2.01; ≥72 hours: aOR, 1.79; 95% CI, 1.27-2.53).

The risk of postoperative C difficile infection demonstrated a similar duration-dependent association (24-<48 hours: aOR 1.08; 95% CI, 0.89-1.31; 48-<72 hours: aOR, 2.43; 95% CI, 1.80-3.27; ≥72 hours: aOR, 3.65; 95% CI, 2.40-5.53).

The unadjusted numbers needed to harm for AKI after 24 to less than 48 hours, 48 to less than 72 hours, and 72 hours or more of postoperative prophylaxis were 9, 6, and 4, respectively; and 2000, 90, and 50 for C difficile infection, respectively.

Vancomycin receipt was also a significant risk factor for AKI (cardiac procedure: aOR, 1.17; 95% CI, 1.10-1.25; noncardiac procedure: aOR, 1.21; 95% CI, 1.13-1.30).

Conclusions and Relevance Increasing duration of antimicrobial prophylaxis was associated with higher odds of AKI and C difficile infection in a duration-dependent fashion; extended duration did not lead to additional SSI reduction. These findings highlight the notion that every day matters and suggest that stewardship efforts to limit duration of prophylaxis have the potential to reduce adverse events without increasing SSI.