Bulletin Today
Ibuprofen was associated with better fever reduction and less pain than acetaminophen when used to lower fever and associated pain in infants and toddlers, according to a study published on October 30 in JAMA Network Open.
Researchers conducted a meta-analysis to compare the effects of acetaminophen and ibuprofen treatment in 240,000 children younger than 2 years. Patients included in the research came from various health care settings in seven different countries.
Compared with acetaminophen, ibuprofen resulted in reduced temperature and less pain within the first 24 hours of treatment. The superiority of ibuprofen as an antipyretic did not continue beyond 24 hours after treatment onset, however, and no data were available on analgesic outcomes at less than 4 hours.
Equivalent safety was found for these two widely prescribed and available OTC medications for fever and pain in children. Acetaminophen and ibuprofen appeared to have similar serious adverse event profiles, and adverse events were uncommon.
“The evidence regarding the risk of serious bacterial infection remains inconclusive, and there are limited data on younger infants and on longer-term adverse events,” the study authors wrote.
Ibuprofen is said to pose a higher risk of kidney toxic effects in younger children, which is why it is commonly avoided. But the researchers said they did not find any evidence to support this view.
“Large, randomized trials are needed to address these knowledge gaps, designed to include and report on the subgroup of infants younger than 6 months and to investigate the safety of acetaminophen and ibuprofen as a primary end point, with long-term follow-up and monitoring for adverse events,” the authors wrote. They also noted that the clinical importance of their findings was uncertain.
FDA publishes list of essential medicines required by executive order
In late October, FDA posted a list of essential medicines, medical countermeasures, and critical inputs following an August 6 executive order requiring the agency to do so.
The list, developed in collaboration with other federal partners, includes 223 essential drug and biological product medicines and medical countermeasures. In addition, the list includes 96 medical device countermeasures, including diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery, and devices for management of acute illnesses, such as ventilators.
“Generally, the essential medicines we identified are those that are most needed for patients in U.S. acute care medical facilities, which specialize in short-term treatment for severe injuries or illnesses, and urgent medical conditions,” said FDA in a statement posted online. “The medical countermeasures we identified are FDA-regulated products (biologics, drugs, and devices) that meet the definition of a ‘medical countermeasure’ provided in the executive order and that we anticipate will be needed to respond to future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats.”
FDA said it focused on including essential medicines and medical countermeasures “that are medically necessary to have available in adequate supply, which can be used for the widest populations to have the greatest potential impact on public health.”
The critical inputs FDA identified include active pharmaceutical ingredients of essential medicines and medical countermeasures and ingredients or components that possess unique attributes essential in assessing the safety and effectiveness of such products.
New analysis finds scant evidence for fibromyalgia treatments
Most therapies and treatment for fibromyalgia seem to lack effectiveness, according to a systematic review with meta-analysis published on October 26 in JAMA Internal Medicine.
The study investigated different therapies for pain reduction and quality of life improvement for people with fibromyalgia. The National Institutes of Health defines fibromyalgia as a chronic disorder that causes muscle pain and fatigue, with the cause still unknown. Individuals with the condition report generalized body pain, fatigue, sleep disturbance, impaired cognition, and anxiety.
Mascarenhas and colleagues looked at 224 original trials in which roughly 30,000 individuals participated. The trials examined 65 different therapies, including single nonpharmacologic treatments, combinations of two or more nonpharmacologic treatments, pharmacologic treatments, a combination of two or more pharmacologic treatments, or a combination of pharmacologic and nonpharmacologic therapy.
Strong evidence seemed to support the use of only cognitive behavioral therapy for pain, as well as antidepressants and central nervous system depressants for pain and quality of life. However, the associations were small, the researchers noted. Evidence was lacking for most other therapies. Specifically, researchers found high-quality evidence supporting the use of cognitive behavioral therapy for pain in the short term; central nervous system depressants and antidepressants for pain in the medium term; antidepressants for quality of life in the short term; and antidepressants and central nervous system depressants for quality of life in the medium term. They also found high-quality evidence that antiemetics were no better than placebo for pain in the short term.
“We did not find any high- or moderate-quality evidence supporting any therapy for pain or QOL [quality of life] in people with fibromyalgia in the long term,” the authors wrote.
NIH sets out to understand more about rare forms of diabetes
The National Institutes of Health (NIH) announced it will fund a nationwide study that seeks to determine the cause of several unusual types of diabetes. For instance, someone with atypical diabetes may be diagnosed and treated for type 1 or type 2 diabetes, but they may not have a history or symptoms consistent with their diagnosis.
The new study, which will be conducted at 20 research institutions, aims to identify new forms of diabetes, understand what makes them different, and learn their causes.
This first nationwide network to study rare forms of diabetes, called the Rare and Atypical Diabetes Network (RADIANT), will screen about 2,000 people with unknown or atypical types of diabetes.
“It’s extremely frustrating for people with atypical diabetes when their diabetes seems so different and difficult to manage,” said the study’s project scientist, Christine Lee, MD, of NIH’s National Institute of Diabetes and Digestive Kidney Diseases, in a news release.
Researchers plan to collect comprehensive health information using questionnaires, physical exams, genetic sequencing, blood samples, and other tests.
“With help from participants and their families, we aim to develop a comprehensive description of the genetic and clinical characteristics of these rare forms of diabetes,” said study chair Jeffrey Krischer, PhD, director of the Health Informatics Institute at the University of South Florida, in the news release. “This information could help to establish new diagnostic criteria for diabetes, find new markers for screening, or identify drug targets for new therapies that could ultimately bring precision medicine to diabetes.”
Enrollment for the study launched in late September for individuals with atypical diabetes or a form of the disease that seems different from known diabetes types.