Five-year trends in acetaminophen use exceeding the recommended daily maximum dose.

Temporal patterns of acetaminophen use exceeding the recommended daily maximum dosage of 4 g over a 5-year period (4/1/2011-3/31/2016) were evaluated in an online 1-week diary study of 14 434 adult acetaminophen users who also reported acetaminophen use in the previous month. Specific medications taken were identified by list-based prompting; respondents were not required to know their medications contained acetaminophen. Details of use were recorded daily; total daily dosage was determined programmatically. Prevalence of >4 g use over time was modelled and tested for linear changes. The overall prevalence of >4 g use (6.3% of users and 3.7% of usage days) did not change over the 5 years: odds ratio (OR) persons, 1.02 (95% CI, 0.98-1.09); OR days, 0.98 (0.92-1.05). Deviations from label directions were largely unchanged, though concomitant use increased slightly. Thus, over a recent 5-year period, there was no evidence of change in how often acetaminophen use exceeded the labelled maximum daily dose.

Exceeding the maximum daily dose of acetaminophen with use of different single-ingredient OTC formulations.

OBJECTIVES: To assess whether there are differences in the likelihood of exceeding the daily limit of 4 grams of acetaminophen when using different formulations (325 mg, 500 mg, 650 mg) of OTC single-ingredient (SI) acetaminophen medications. DESIGN AND SETTING: Multiyear observational study of acetaminophen use via daily online acetaminophen-usage diaries completed for 7 days. PARTICIPANTS: A total of 7579 U.S. adults from online research panels who used acetaminophen in the month preceding enrollment and used an OTC SI acetaminophen medication during the study. OUTCOME MEASURE: Exceeding the daily dose. RESULTS: On days when 325-mg or 500-mg OTC SI formulations were taken, users were not significantly more likely to exceed 4 grams than on days when OTC SI formulations were not used. On days when 650-mg extended-release (ER) formulations were taken, exceeding 4 grams was significantly more likely (8.9% of days vs. 4.4%; P < 0.0001; median on those days was 5.2 g) than on days with 325- or 500-mg OTC SI formulations. Users of 650-mg ER formulations were significantly less likely to know their dosing interval of 8 hours (33% vs. 49%; P < 0.0001) and more likely to redose too soon (26% vs. 10%; P < 0.0001) and to use other acetaminophen medications concomitantly (14% vs. 7%; P < 0.0001). These patterns were strongest among 650-mg ER products that did not include "8-Hour" in the product name. CONCLUSION: Usage of 500-mg OTC SI acetaminophen formulations does not contribute differently to exceeding dosage compared with other OTC SI acetaminophen formulations. Exceeding 4 grams is more likely when 650-mg ER formulations are used. Improved consumer information on the packages and counseling from pharmacists may help to reduce practices that contribute to exceeding the labeled daily limit of these medications.

Knowledge of dosing directions among current users of acetaminophen-containing medications.

OBJECTIVES: Users should know the active ingredients and dosing directions to optimize the safe use of acetaminophen-containing medications. The aim of this work was to examine knowledge of acetaminophen-containing medication directions among current users. DESIGN, SETTING, AND PARTICIPANTS: An Internet panel diary study (2012-2016) of 1-week usage of acetaminophen medications (over-the-counter [OTC] and prescription), recorded daily; 9629 participants. Users were asked about ingredients of medications taken; specific dosing instructions were asked for each OTC medication taken. Subjects were considered to be correct only if an accurate response was provided for all of the medications they used. OUTCOME MEASURES: Analyses examined prevalence of several aspects of knowledge and their relation to the corresponding deviations from directions. Knowledge that acetaminophen was an ingredient was compared between medication types. RESULTS: Two-thirds of 5161 participants who used only 1 acetaminophen medication knew the ingredient; the proportion was almost halved in 4468 users of 2 or more. Ingredient knowledge was highest for single-ingredient medications (74%); for combination medications it ranged from 39% (cough or cold) to 61% (sleep or other non-pain). About one-third knew the prohibition against concomitant use of multiple acetaminophen medications; 85% knew the maximum one-time OTC dose, but only 47% knew the minimum interval between doses. Correct knowledge was inversely associated with violating the relevant label directions; in particular, knowing the one-time dose decreased the odds of taking too much at one time fivefold. Knowing both the ingredient and the concomitant use prohibition decreased the odds of concomitant use by 50%. CONCLUSIONS: Knowledge of directions for safe use of acetaminophen-containing medications is poor, and its deficiency is associated with corresponding deviations from label instructions. This study demonstrates a need for education about safe use of acetaminophen-containing medications, particularly for combination products.

Prevalence of exceeding maximum daily dose of paracetamol, and seasonal variations in cold-flu season.

AIMS: To estimate prevalence of excess intake of paracetamol and investigate seasonal variations therein. METHODS: Between 2011 and 2016, 14 481 US adults who used paracetamol in the preceding 30 days were sampled from national online panels and completed a detailed online daily diary of paracetamol medication use for 7 days. Respondents were not told that the study concerned paracetamol. Cold/flu season (CFS), identified using Google Trends data, was contrasted to off-season in symptoms, use of paracetamol medications, and consumption exceeding 4 g (the recommended daily maximum). RESULTS: Overall, 6.3% [95% confidence interval: 5.9-6.7%] of users exceeded 4 g on at least one day; 3.7% [3.5-3.8%] of usage days exceeded 4 g. Cold/flu symptoms were more likely to be experienced and treated with paracetamol in CFS than off-season. Paracetamol users were more likely to exceed 4 g during CFS (6.5% vs. 5.3%; odds ratio = 1.24, 1.04-1.48); days exceeding 4 g also increased (3.9% vs. 2.8%; odds ratio = 1.37, 1.11-1.69). This was not due to differences in characteristics of individuals using paracetamol in CFS, but primarily to increased use of over-the-counter combination medications designed to treat upper respiratory cold/flu symptoms (33.2% of usage days in CFS vs. 24.8% in off-season; odds ratio = 1.58, 1.46-1.72). When such medications were omitted, there was no statistically significant seasonal variation in exceeding 4 g. CONCLUSIONS: Paracetamol use and over-dosing increases in CFS, primarily due to increased use of over-the-counter combinations treating upper respiratory cold/flu symptoms. Pharmacists should warn users to follow labelled dosing directions, especially during CFS.

Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users.

PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective and very commonly used, but also have side effects. We determined prevalence of NSAID dosing exceeding the daily limit (EDL) and identified related user characteristics and dosing patterns among current ibuprofen users. METHODS: Online 1-week diary study of 1326 ibuprofen users. NSAIDs were identified by list-based prompting; respondents were not required to know their medications were NSAIDs. Details of hourly use were recorded by respondents daily. Deviations from dosing directions were programmatically determined afterwards. An exit survey obtained information on demographics, medical history, physical and mental health status, attitudes regarding label reading and dosing behavior, and knowledge of product label instructions. RESULTS: Most diary users (90%) took over-the-counter ibuprofen during the week; 37% also took non-ibuprofen NSAIDs. Most did not recognize all products taken as NSAIDs. EDL occurred among 11% of users for ibuprofen, 4% of users for other NSAIDs, and on 9.1% of NSAID usage days. EDL was associated with deviations from detailed dosing directions, particularly exceeding the 1-time dose, which occurred more often with medications with 1-pill doses. Personal characteristics associated with EDL included male sex, ongoing pain, poor physical function, daily smoking, having the attitudes of "choosing my own dose" and not starting with the lowest dose, and poor knowledge of the recommended 1-time and 24-hour doses. CONCLUSIONS: The prevalence of EDL among NSAID users is nontrivial, and it is associated with potentially modifiable factors. Educating consumers about NSAIDs and their dosing directions could reduce excess dosing.

Relation of Health Literacy to Exceeding the Labeled Maximum Daily Dose of Acetaminophen.

INTRODUCTION: Acetaminophen is a commonly used analgesic/antipyretic; overdoses can lead to liver damage. Little is known about the relationship of health literacy to exceeding the recommended maximum daily dose (4 g). METHODS: Subjects were recruited at 23 U.S. malls in 2011. Health literacy was measured by Rapid Estimate of Adult Literacy in Medicine (REALM), classified as very low (VLL, score <45); low (LL, 45-60); or adequate (AL, >60). Participants completed a 7-day acetaminophen use diary by daily telephone interview; an exit interview covered demographics, physical/mental health, medical history, medication label reading, and medication-taking knowledge/attitudes. Acetaminophen products were identified from a comprehensive list; subjects were not required to know their medications contained acetaminophen. Seven hundred fifty-six subjects aged ≥18 years had taken acetaminophen in the past 30 days and completed 7 diary days with ≥1 day of acetaminophen use, plus the exit survey. Analysis was conducted in 2012-2014. RESULTS: VLL were more likely than AL individuals to exceed 4 g on ≥1 day (OR [95% CI]=3.8 [1.5, 9.6]; 4.0 [1.3, 12] after controlling for five REALM score-related factors). On usage days, VLL individuals were also more likely to exceed 4 g (3.3 [1.1, 10], by generalized estimating equations; 2.4 [0.9, 6.6], direct effect after accounting for mediation by other deviations from label recommendations). CONCLUSIONS: VLL individuals exceed the recommended maximum acetaminophen dose more often than AL individuals. Other identified characteristics related to health literacy do not explain this, but it is partly mediated by increased frequency of other label deviations.

Patterns of acetaminophen medication use associated with exceeding the recommended maximum daily dose.

BACKGROUND: Acetaminophen overuse has been linked to liver injury. PURPOSE: To identify patterns of medication use associated with exceeding the recommended daily maximum dose of 4 g acetaminophen. METHODS: Respondents from a national panel completed a detailed daily medication diary online for 7 days (n = 5649), identifying medications taken from a comprehensive list of over-the-counter (OTC) and prescription (Rx) acetaminophen medications. Respondents were not told the study concerned acetaminophen. Total daily intake was calculated from diary data. Generalized estimating equations assessed the association of medication patterns with exceeding 4 g per day among 3618 respondents who used acetaminophen medications (on 13,852 days) during the diary period. RESULTS: Acetaminophen intake exceeded 4 g on 3.1% of usage days; median intake on those days was 5.5 g. As expected, days when intake exceeded 4 g were almost always (92%) marked by deviations from label directions-exceeding the one-time dose, re-dosing too soon, and concomitant use of multiple acetaminophen medications. Re-dosing too soon was the most frequent deviation, and concomitant use was most strongly tied to exceeding the daily limit. Use of both an Rx and an OTC medication on the same day also increased the odds of exceeding 4 g on days when concomitant use occurred. CONCLUSIONS: Excess dosing of acetaminophen is associated with deviations from label directions and by use of both OTC and Rx medications containing acetaminophen within a single concomitant use day.

Prevalence and correlates of exceeding the labeled maximum dose of acetaminophen among adults in a U.S.-based internet survey.

PURPOSE: Acetaminophen is a commonly used analgesic; excessive doses can lead to liver damage. We sought to determine the proportion of acetaminophen users exceeding the recommended maximum daily dose of 4 g and identify correlates of such behavior. METHODS: U.S. adults were recruited from an internet panel in summer 2010, oversampling past 30-day acetaminophen users. Among 47 738 starting the study, 5649 completed all phases; individuals with low education were underrepresented. Subjects completed a 7-day daily diary online, reporting intake of acetaminophen products selected from a comprehensive list; total daily dose was computed from product names. An exit survey elicited: attitudes/knowledge related to product ingredients, label reading, dosing behavior; demographics, medical history, general physical, and mental health status. Unconditional logistic regression identified variables independently associated with use exceeding 4 g. RESULTS: Among 3618 acetaminophen users, 163 took >4 g on ≥1 day (4.5%); the median dose was 5.5 g; 26 took >8 g (0.7%). >4-g users were characterized by chronic pain, poor physical status, and heavy use of medical care. Knowledge of ingredients and recommended OTC doses for all products taken was inversely associated with >4-g use (multivariable odds ratios [ORs] = 0.5-0.6), as was the attitude to start with the lowest dose (OR = 0.6). The attitude that users could choose their own dose was positively associated (OR = 1.3). CONCLUSIONS: The results estimate the proportion of acetaminophen users exceeding 4 g in a group of U.S. adults, identify potentially modifiable attitudes and knowledge associated with such use, and characterize subpopulations at higher risk.

Neurodevelopmental outcomes in children with hemifacial microsomia.

OBJECTIVE: To determine whether preadolescent children with hemifacial microsomia (HFM) have higher risk of neurodevelopmental delays than unaffected control individuals. DESIGN: Case-control follow-up study of neurodevelopment in children with and without HFM. SETTING: Case individuals were originally recruited from 26 craniofacial centers across the United States and Canada, and controls were recruited through community pediatricians. PARTICIPANTS: One hundred thirty-six children with HFM (cases) and 568 unaffected children (controls). Main Exposure  History of HFM. MAIN OUTCOME MEASURES: The Peabody Picture Vocabulary Test-Third Edition, the Beery-Buktenica Developmental Test of Visual Motor Integration-Fifth Edition, and the Academic Competence scales from the Child Behavior Checklist and the Teacher Report Form. RESULTS: Children with HFM scored lower than controls on all measures (effect size = -0.27 to -0.45; P < .001 to P = .008). Compared with controls, cases were 2 to 3 times as likely to score in the at-risk range. Relative to controls, outcomes were worse for male cases and those whose mothers were 25 years or younger at the time of their birth. Cases with HFM plus other malformations had poorer outcomes, as did cases with hearing, vision, or speech impairments. CONCLUSIONS: This is the first study, to our knowledge, to show that children with HFM have poorer neurodevelopmental outcomes than unaffected children, but further study using more detailed assessments is indicated. Clinically, the findings suggest that early neurodevelopmental screening is warranted for all children with HFM.

Psychosocial outcomes in children with hemifacial microsomia.

OBJECTIVE: To determine whether children with hemifacial microsomia (HFM) have higher risk for psychosocial problems than children without HFM. METHODS: One hundred and thirty-six children with HFM (64% male, mean age = 6.9 years) were compared to 568 matched controls (50% male, mean age = 7.0 years) on parent and teacher measures of behavior problems and social competence, and teacher rankings of peer acceptance. RESULTS: Parents of cases and controls reported similar levels of behavior problems and social competence. Teachers reported higher frequencies of internalizing problems, lower social competence and less peer acceptance for cases. Relative to controls, teacher-rated outcomes were worse for female cases, those with younger mothers at the time of birth, those with eye anomalies, and those with one or more malformations in addition to the core features of HFM. CONCLUSIONS: This study provides the first evidence of relatively poor psychosocial outcomes among children with HFM.

Vitamin, fluoride, and iron use among US children younger than 12 years of age: results from the Slone Survey 1998-2007.

Pediatric vitamin and mineral supplements are thought to be used commonly in the United States, but details of their use are lacking. Using data from the Slone Survey (a cross-sectional national random-digit-dial medication use survey), this study sought to define the prevalence and patterns of use of supplemental vitamins, fluoride, and iron among US children younger than 12 years of age. Primary statistical analyses involved descriptive statistics and calculation of weighted prevalence of use estimates with 95% confidence intervals. Between February 1998 and April 2007, there were 2,857 children 0 to 11 years of age enrolled from the 48 contiguous United States with weighted prevalence of use of vitamins, iron, and fluoride as the primary outcome. The response rate to the survey was 61%. Overall, 23.1% of children had used a vitamin, fluoride, or iron supplement in the 7 days before the interview, with use being highest among 2- to 5-year-olds. Almost all vitamins and most fluoride and iron were taken in the form of multicomponent products. The most commonly taken specific vitamins were C, D, B-12, B-6, and B-2, each by >20% of children. Overall, 3.3% of study participants took supplemental fluoride and 9.7% took supplemental iron. In conclusion, this study found that almost one-quarter of US children younger than 12 years of age, and 30% of 2-year-olds, use supplemental vitamins, fluoride, and iron in a given week. These data should be combined with what is known about the need for pediatric supplementation with vitamins, fluoride, and iron to help clinicians and policy makers counsel parents about the optimal use of these products.

General exposures to prescription medications by race/ethnicity in a population-based sample: results from the Boston Area Community Health Survey.

PURPOSE: Few recent U.S. studies have examined population-based patterns in prescription drug use and even fewer have considered detailed patterns by race/ethnicity. In a representative community sample, our objectives were to determine the most commonly used prescription drug classes, and to describe their use by age, gender, and race/ethnicity. METHODS: Cross-sectional epidemiologic study of 5503 (1767 black, 1877 Hispanic, 1859 white) community-dwelling participants aged 30-79 in the Boston Area Community Health (BACH) Survey (2002-2005). Using medication information collected from an in-home interview and medication inventory, the prevalence of use of a therapeutic class (95% confidence interval (95%CI)) in the past month was estimated by gender, age group, and race/ethnicity. Estimates were weighted inversely to the probability of sampling for generalizablity to Boston, MA. RESULTS: The therapeutic class containing selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants was most commonly used (14.6%), followed by statins (13.9%), beta-adrenergic blockers (10.6%), and angiotensin-converting enzyme (ACE) inhibitors (10.5%). Within all age groups and both genders, black participants were substantially less likely than white to use SSRI/SNRI antidepressants (e.g., black men: 6.0% [95%CI: 3.9-8.1%]; white men: 15.0% [95%CI: 10.2-19.4%]). Other race/ethnic differences were observed: for example, black women were significantly less likely than other groups to use benzodiazepines (e.g., black: 2.6% [95%CI: 1.2-3.9%]; Hispanic: 9.4% [95%CI: 5.8-13.0%]). CONCLUSIONS: Race/ethnic differences in use of prescription therapeutic classes were observed in our community sample. Examining therapeutic classes rather than individual drugs resulted in a different distribution of common exposures compared to other surveys.

Medication use among children <12 years of age in the United States: results from the Slone Survey.

OBJECTIVES: Using data from the Slone Survey, we sought to define the prevalence of over-the-counter and prescription medication use among US children <12 years of age and to determine the prevalence and patterns of use of the most commonly used medications. METHODS: The Slone Survey was a random-digit-dial telephone survey of medication use in the previous 7 days for a representative sample of the US population. Between February 1998 and April 2007, we enrolled 2857 children 0 to 11 years of age from the 48 contiguous US states. RESULTS: The survey response rate was 61%. Overall, 56% of children had used >or=1 medication product in the 7 days preceding the interview, with 15%, 7.1%, 3.1%, and 1.9% taking 2, 3, 4, and >or=5 medications, respectively, during that time period. Twenty percent of children took >or=1 prescription-only medications, but <6% used >or=2 prescription-only drugs within a given week. Fewer than 0.5% of children were reported to have used any particular herbal product. The most commonly used over-the-counter medication products were acetaminophen alone, multivitamins, and ibuprofen alone. The most commonly used prescription-only medications across all age groups were amoxicillin, albuterol, and multivitamins with fluoride. The most commonly consumed active ingredients (excluding vitamins) were acetaminophen, iron, ibuprofen, and various cough/cold ingredients (pseudoephedrine, dextromethorphan, and various first-generation antihistamines). CONCLUSIONS: The majority of US children <12 years of age use >or=1 medication product in a given week. The preponderance of pediatric medication exposure involves over-the-counter products.

Emergency department visits attributed to selected analgesics, United States, 2004-2005.

PURPOSE: To estimate the rate of emergency department (ED) visits attributed to selected analgesic-containing medications. METHODS: We used a nationally representative public health surveillance system to provide estimates of adverse events identified in EDs, and a national telephone survey to provide estimates of selected analgesic-containing medication usage in the US population, 2004-2005. Analysis was restricted to products containing acetaminophen, aspirin, ibuprofen, or naproxen. Types of adverse events and outcomes were compared. Estimated numbers and rates of ED visits were calculated by analgesic groupings and patient age groups. RESULTS: The estimated overall rate of ED visits attributed to analgesic-containing medications was 1.6 visits /100,000 users per week. The very old and very young had the highest rates; there were minimal differences in rates by patient gender. Acetaminophen was the attributed drug with the most estimated ED visits and generally had the highest rates of ED visits. The highest estimated rate for a specific product group was among subjects 18-64 years of age taking narcotic-acetaminophen products (8.9 ED visits /100,000 users per week). Overall, 12% of patients presenting to EDs with analgesic-attributed events were hospitalized. CONCLUSIONS: Rates of ED visits due to analgesics vary depending on the age of the patient and the product; most do not result in hospitalization. Although the rate of emergency visits is relatively low, because of the wide use of the analgesics, public health impact is considerable.

Medications as risk factors of Stevens-Johnson syndrome and toxic epidermal necrolysis in children: a pooled analysis.

OBJECTIVE: The aim of this study was to determine the relation of medications to the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis in children <15 years of age. METHODS: We conducted a pooled analysis by using data from 2 multicenter international case-control studies: the severe cutaneous adverse reaction (SCAR) study and the multinational severe cutaneous adverse reaction (EuroSCAR) study conducted in France, Germany, Italy, Portugal, the Netherlands, Austria, and Israel. We selected case subjects aged <15 years, hospitalized for Stevens-Johnson syndrome, Stevens-Johnson syndrome/toxic epidermal necrolysis-overlap, or toxic epidermal necrolysis, and age-, gender-, and country-matched hospital controls. Pooled crude odds ratios were estimated and adjusted for confounding by multivariate methods when numbers permitted. RESULTS: Our study included 80 cases and 216 matched controls. Antiinfective sulfonamides, phenobarbital, carbamazepine, and lamotrigine were strongly associated with the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis. Significant associations were highlighted in univariate analysis for valproic acid and nonsteroidal antiinflammatory drugs as a group and for acetaminophen (paracetamol) in multivariate analysis. CONCLUSIONS: We confirmed 4 previously highly suspected drug risk factors for Stevens-Johnson syndrome/toxic epidermal necrolysis in children: antiinfective sulfonamides, phenobarbital, carbamazepine, and lamotrigine. Among more unexpected risk factors, we suspect that acetaminophen (paracetamol) use increases the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis.

Pseudoephedrine use among US children, 1999-2006: results from the Slone survey.

OBJECTIVE: Pseudoephedrine, a decongestant found in many cough-and-cold and allergy medications, has been associated with deaths and adverse events in young children; however, the absolute risks of pediatric pseudoephedrine use are difficult to assess because the number of children exposed on a population basis and typical patterns of use are unknown. In addition, use may be changing because of the Combat Methamphetamine Epidemic Act of 2005, which limited pseudoephedrine availability. We sought to describe the prevalence and patterns of pseudoephedrine use among US children and to assess any change since the 2005 law took effect. METHODS: We analyzed data on pseudoephedrine use among 4267 children who were aged 0 to 17 years and enrolled from 1999 to 2006 in the Slone Survey, a national random-digit-dial telephone survey of medication use in the US population. RESULTS: Overall, 214 children took pseudoephedrine in a given week. Use was highest for children who were younger than 2 years. Sixteen children (7.5% of users) took >1 pseudoephedrine-containing product within the same week, including 6 children who were younger than 2 years. Of the pseudoephedrine products used, most were multiple-ingredient liquids (58.9%) and multiple-ingredient tablets (24.7%). Fifty-two children (25.0% of users) took pseudoephedrine for >1 week, including 7 children who were younger than 2 years. Use in 2006 (2.9%) was significantly lower than in 1999-2005 (5.2%). CONCLUSIONS: Pseudoephedrine exposure, mostly in the form of multiple-ingredient products, is common among US children, especially children who are younger than 2 years, who are at the highest risk for toxicity and for whom safe dosing recommendations are lacking. Concerning patterns of use include taking >1 pseudoephedrine-containing product concurrently and using pseudoephedrine for extended periods. Pediatric pseudoephedrine use seems to be declining since the institution of the 2005 Combat Methamphetamine Epidemic Act.

Cough and cold medication use by US children, 1999-2006: results from the slone survey.

OBJECTIVE: Pediatric cough and cold medications are widely marketed in the United States, but the precise patterns of use among children are not known. Such information is especially important given recent reports suggesting that these medications are responsible for previously underappreciated serious adverse events and deaths among children. We sought to describe the prevalence and patterns of pediatric use of cough and cold medications, with particular attention to use among young children. METHODS: We analyzed data on the use of cough and cold medications, defined as any oral medication that contains >or=1 antitussive, decongestant, expectorant, and/or first-generation antihistamine active ingredients, among 4267 US children who were younger than 18 years and enrolled during 1999-2006 in the Slone Survey, a national random-digit-dial telephone survey of medication use by the US population. RESULTS: In a given week, a cough and cold medication was used by 10.1% of US children. Exposure was highest to decongestants (6.3%; mostly pseudoephedrine) and first-generation antihistamines (6.3%; most common were chlorpheniramine, diphenhydramine, and brompheniramine), followed by antitussives (4.1%; mostly dextromethorphan) and expectorants (1.5%; almost exclusively guaifenesin). Multiple-ingredient products accounted for 64.2% of all cough and cold medications used. Exposure to antitussives, decongestants, and first-generation antihistamines was highest among 2- to 5-year-olds (7.0%, 9.9%, and 10.1%, respectively) followed by children who were younger than 2 years (5.9%, 9.4%, and 7.6%, respectively); expectorant use was low in all age groups. The use of cough and cold medications declined from 1999 through 2006. CONCLUSIONS: Approximately 1 in 10 US children uses a cough and cold medication in a given week. The especially high prevalence of use among children of young age is noteworthy, given concerns about potential adverse effects and the lack of data on the efficacy of cough and cold medications in this age group.

Oxalobacter formigenes may reduce the risk of calcium oxalate kidney stones.

Most kidney stones are composed primarily of calcium oxalate. Oxalobacter formigenes is a Gram-negative, anaerobic bacterium that metabolizes oxalate in the intestinal tract and is present in a large proportion of the normal adult population. It was hypothesized that the absence of O. formigenes could lead to increased colonic absorption of oxalate, and the subsequent increase in urinary oxalate could favor the development of stones. To test this hypothesis, a case-control study involving 247 adult patients with recurrent calcium oxalate stones and 259 age-, gender-, and region-matched control subjects was performed. The prevalence of O. formigenes, determined by stool culture, was 17% among case patients and 38% among control subjects; on the basis of multivariate analysis controlling demographic factors, dietary oxalate, and antibiotic use, the odds ratio for colonization was 0.3 (95% confidence interval 0.2 to 0.5). The inverse association was consistently present within strata of age, gender, race/ethnicity, region, and antibiotic use. Among the subset of participants who completed a 24-h urine collection, the risk for kidney stones was directly proportional to urinary oxalate, but when urinary factors were included in the multivariable model, the odds ratio for O. formigenes remained 0.3 (95% confidence interval 0.1 to 0.7). Surprisingly, median urinary oxalate excretion did not differ with the presence or absence of O. formigenes colonization. In conclusion, these results suggest that colonization with O. formigenes is associated with a 70% reduction in the risk for being a recurrent calcium oxalate stone former.

Lung cancer and regular use of aspirin and nonaspirin nonsteroidal anti-inflammatory drugs.

PURPOSE: Lung cancer is the leading cause of cancer death in the US. There is evidence of a reduced risk of some cancer sites associated with use of aspirin (ASA) and nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs). Our objective was to examine the association of regular use of ASA and NANSAIDs with lung cancer. METHODS: A hospital-based case-control study of 1884 incident cases of lung cancer and 6251 controls with noncancer diagnoses. Use of ASA and NANSAIDs was considered 'regular' if it occurred on > or =4 days/week and lasted for > or =3 months. Logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals. RESULTS: The OR for regular use of ASA was 1.1 (0.9-1.4), and the corresponding estimate for regular NANSAID use was 1.0 (0.7-1.3). There was no evidence of decreased risk within strata of age, sex, years of education, or interview year. Examining the association within strata of duration of use, recency of use, cigarette smoking status, pack-years of cigarette smoking, or histologic type of cancer produced no ORs significantly different from 1.0. CONCLUSIONS: The hypothesis that regular use of ASA or NANSAIDs reduces the risk of lung cancer is not supported by the present data.

Non-contrast-enhanced computerized tomography and analgesic-related kidney disease: report of the national analgesic nephropathy study.

Previous studies suggested that the non-contrast-enhanced computerized tomography (CT) scan is a highly reliable tool for the diagnosis of analgesic-associated renal disease. However, this issue has not been addressed in the US population. A total of 221 incident patients with ESRD from different regions of the United States underwent a helical CT scan and detailed questioning about drug history. Specific renal anatomic criteria were developed to determine whether a constellation of CT findings (small indented calcified kidneys [SICK]) is linked to analgesic ingestion. For approximating use before the onset of renal disease, only analgesic ingestion at least 9 yr before starting dialysis was considered relevant. Fifteen patients met the criteria for SICK. This represented 7% of the enrolled patients and approximately 1% of the total ESRD population. There was a significant increase in the estimated risk among patients with a history of heavy aspirin ingestion (odds ratio [OR] 7.4 [95% confidence interval (CI) 1.2 to 43] for > or =1 kg lifetime; OR 8.8 [95% CI 1.2 to 66] for > or =0.3 kg/yr). Total analgesic ingestion of > or =0.3 kg/yr also was significantly associated with SICK (OR 8.2; 95% CI 1.5 to 45). These findings were accounted for largely by combination products that contained aspirin and phenacetin (used by three patients with SICK), which are no longer available. In addition, the CT finding of SICK was present only in a minority of heavy analgesic users, yielding a sensitivity of 5 to 26%. Findings of SICK are infrequent in the US ESRD population and do not occur among a sufficient proportion of heavy analgesic users to render the non-contrast-enhanced CT scan a sensitive tool to detect analgesic-associated kidney injury.