Cold Preparation Use in Young Children After FDA Warnings

Lazarus, Sarah; Lanski, Steven L.; Smith, Ashley S.; Simon, Harold K.

doi:10.1177/0009922813482761

Cited by 11 publications

(11 citation statements)

References 7 publications

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“…19 However, national household surveys and surveys of caregivers of children treated in EDs indicate that many caregivers still give CCMs to young children. 20–23 …”

mentioning

confidence: 99%

Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision

Hampton¹,

Nguyen

Edwards³

et al. 2013

Pediatrics

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BACKGROUND In October 2007, manufacturers voluntarily withdrew over-the-counter (OTC) infant cough and cold medications (CCMs) from the US market. A year later, manufacturers announced OTC CCM labeling would be revised to warn against OTC CCM use by children aged <4 years. We determined whether emergency department (ED) visits for CCM adverse drug events (ADEs) declined after these interventions. METHODS We used National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance data from 2004 to 2011 to estimate the number of ED visits for CCM ADEs before and after each intervention. RESULTS Among children aged <2 years, ED visits for CCM ADEs decreased from 4.1% of all ADE ED visits before the market withdrawal to 2.4% of all ADE visits afterward (difference in proportion: –1.7%, 95% confidence interval [CI]: –2.7% to –0.6%). Among children aged 2 to 3 years, ED visits for CCM ADEs decreased from 9.5% of all ADE ED visits before the labeling revision announcement to 6.5% of all ADE visits afterward (difference in proportion: –3.0%, 95% CI: –5.4% to –0.6%). Unsupervised ingestions accounted for 64.3% (95% CI: 51.1% to 77.5%) of CCM ADE ED visits involving children aged <2 years after the withdrawal and 88.8% (95% CI: 83.8% to 93.8%) of visits involving children aged 2 to 3 years after the labeling revision announcement. CONCLUSIONS After a voluntary market withdrawal and labeling revision, ED visits for CCM ADEs declined among children aged <2 years and 2 to 3 years relative to ADE ED visits for all drugs. Interventions addressing unsupervised ingestions are needed to reduce CCM ADEs.

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“…19 However, national household surveys and surveys of caregivers of children treated in EDs indicate that many caregivers still give CCMs to young children. 20–23 …”

mentioning

confidence: 99%

Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision

Hampton¹,

Nguyen

Edwards³

et al. 2013

Pediatrics

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“…Authors from a study conducted recently in Kenya arrived at the same conclusions [ 43 , 44 ]. However, despite international warnings, cough and cold medications including those with potentially harmful ingredients are still used in children, including those aged below 2 years in many parts of the world [ 45 , 46 ].…”

Section: Discussionmentioning

confidence: 99%

A Review of the Ingredients Contained in Over the Counter (OTC) Cough Syrup Formulations in Kenya. Are They Harmful to Infants?

et al. 2015

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BackgroundCough syrups are widely used in the developing world, but safety of their use in infants and children less than two years has not been well documented. Some syrups contain multiple combinations of such drugs as promethazine, diphenhydramine and ephedrine; which are individually now contraindicated in children less than two years. Despite this, the syrups are available as over the counter drugs and may be dispensed to mothers who are unaware of the potentially hazardous effects to their infants. A descriptive cross-sectional study was used to investigate suitability of cough syrups sold within Eldoret municipality for use in children less than two years of age based on their formulations and available literature.MethodsTwo semi-structured questionnaires were administered to pharmacy attendants and mothers attending sick child clinic at a referral hospital to establish whether cough syrups containing more than one active ingredient of compounds, now contraindicated in children are administered to infants, and awareness of potential serious adverse effects. Data from labeled contents of cough syrups from retail pharmacies was recorded and corroborated with information from literature to determine those deemed to contain the ingredients. The second questionnaire was administered to mothers with children less than two years to ascertain whether they had used the identified syrups. A total of 260 mothers and 55 pharmacy attendants were interviewed.ResultsThere was widespread use of the syrups in children, including infants, with 192 (74%) of the respondents having used identified syrups and over 90% of these on children less than 2 years including those less than three months.146 (76%) mothers had administered the syrup at double the recommended dose.ConclusionThe regulatory authorities should make concerted efforts to discourage use of cough syrups containing ingredients that pose adverse events to infants, including campaigns to educate pharmacy workers and mothers.

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“…9 On the other side, the U.S. Food and Drug Administration (FDA) and the American Academy of Pediatrics (AAP) released joint statements against the use of cough and cold products containing sedating H1-Antihistamines in children younger than 6 years due to safety concerns in 2008. 10 …”

Section: Introductionmentioning

confidence: 99%

No Time for Lullabies: Tracing down Pharmacological Effects & Uses of H1-Antihistamines in Children Younger than 6 Years

Yehya

Numan

Matalqah

2021

Global Pediatric Health

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Objectives. To provide a qualitative and a quantitative analysis of H1-antihistamines pharmacological uses pattern among children (<6 years old) and to evaluate the parental-related awareness. Methods. A cross-sectional study was carried out at 5 retail pharmacies in Jordan over 5 months (October/2019-February/2020). Parents who requested any of H1-antihistmine agent for a child (<6 years) were invited to participate. Results. A total of 516 children, most of them were toddlers (1-3) years, received at least 1 H1-antihistamine. More than half of the cases received H1-antihistamine as self-medication (56.3%). Sedating antihistamine agents were the most frequently used among children (<6 years old) (77.9%) among which Chlorpheniramine maleate was the most commonly used agent (62.9%). About half of the children (47.0%) received H1-antihistamine to induce sleep. Whereas, 21.7% and 12.9% received them to manage flu, and allergic rhinitis (AR), respectively. Around 66.6% of the cases were classified as off-label use. Most of the parents (80.5%) were aware of the sedative adverse effects of H1-antihistamines, whereas a fewer number (31.9%) were aware of their cognitive effects. Finally, more than two thirds of parents (79.7%) were unfamiliar with off-label drug use in children. Conclusion. Despite the availability of less-sedating H1-antihistamines with a wide safety and efficacy record, the use of sedating H1-antihistamines remains popular in children.

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Cold Preparation Use in Young Children After FDA Warnings

Abstract: Despite current recommendations, cough and cold medicines are still used in children younger than 6 years of age. A significant portion of caregivers report that they are still unaware of public warnings, potential side effects, and interactions with other medications.

Cited by 11 publications

References 7 publications

Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision

Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision

A Review of the Ingredients Contained in Over the Counter (OTC) Cough Syrup Formulations in Kenya. Are They Harmful to Infants?

No Time for Lullabies: Tracing down Pharmacological Effects & Uses of H1-Antihistamines in Children Younger than 6 Years

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