Adverse Events From Cough and Cold Medications After a Market Withdrawal of Products Labeled for Infants

Abstract

WHAT'S KNOWN ON THIS SUBJECT:A voluntary market withdrawal of orally administered, over-the-counter cough and cold medications (CCMs) labeled for infants was announced in October 2007 because of concerns regarding limited evidence of efficacy and potential harmful effects of these products among young children. WHAT THIS STUDY ADDS:This study assessed changes in CCMrelated harm, as measured with national estimates of emergency department visits for CCM-related adverse events, among children after announcement of the withdrawal of orally administered, over-the-counter, infant CCMs. abstract OBJECTIVE: A voluntary market withdrawal of orally administered, over-the-counter, infant cough and cold medications (CCMs) was announced in October 2007. The goal of this study was to assess CCMrelated adverse events (AEs) among children after the withdrawal. METHODS:Emergency department (ED) visits for CCM-related AEs among children Ͻ12 years of age were identified from a nationally representative, stratified, probability sample of 63 US EDs, for the 14 months before and after announcement of withdrawal. RESULTS:After withdrawal, the number and proportion of estimated ED visits for CCM-related AEs involving children Ͻ2 years of age were less than one-half of those in the prewithdrawal period (1248 visits [13.3%] The use of cough and cold medications (CCMs) for children recently garnered increased attention because of concerns regarding the potential harmful effects of these medications when used inappropriately and limited evidence for their efficacy, particularly for infants and young children. 1-9 On October 11, 2007, on behalf of the leading makers of over-the-counter (OTC) CCMs, the Consumer Healthcare Products Association announced a voluntary market withdrawal of orally administered CCMs labeled or intended for infants. 10 This was followed by a US Food and Drug Administration (FDA) recommendation on January 17, 2008, to avoid use of these products to treat infants and children Ͻ2 years of age, "because serious and potentially lifethreatening side effects can occur." 11 Here, we use nationally representative public health surveillance data to assess potential changes in the number of emergency department (ED) visits because of CCM-related adverse events (AEs) after announcement of the withdrawal of OTC products for infants. METHODSNational estimates of ED visits for AEs were based on surveillance cases from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance (NIESS-CADES) project, which involves a nationally stratified, probability sample of 63 hospitals in the United States and its territories with a minimum of 6 beds and a 24-hour ED. 12 All hospitals treat pediatric patients, and 5 are pediatric specialty hospitals. The NEISS-CADES project is a collaboration of the Centers for Disease Control and Prevention (CDC), the FDA, and the US Consumer Product Safety Commission and was described previously. 12,13 In brief, trained coders at each hospital review clinical records of...

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

“…We assessed ED visits involving children 2 to 11 years old before and after October 1, 2008, because previous studies found that the 2007 withdrawal of infant products had not significantly affected CCM ADEs among children $2 years old. 1,10 Each NEISS-CADES case is assigned a sample weight based on the inverse probability of selection. The sample weights are modified for nonresponse rate and poststratified to adjust for the number of annual hospital ED visits.…”

“…[1][2][3][4] Studies had not demonstrated CCMs to be more effective than placebo in young children but had linked CCMs to significant numbers of emergency department (ED) visits and, in rare cases, infant deaths. [5][6][7][8] The Food and Drug Administration (FDA) formally supported this withdrawal in January 2008.…”

“…9 The next year, ED visits and calls to poison centers due to CCM adverse drug events (ADEs) involving young children declined. 1,10 In October 2008, manufacturers of OTC CCMs announced, with FDA support, that OTC CCM labels would be revised to state that the medications should not be used in children <4 years old. 11,12 Media attention and ongoing educational efforts by the FDA, 13,14 professional organizations such as the American Academy of Pediatrics, 15 and trade groups followed.…”

Profil Penggunaan Obat Batuk Pilek Bebas Pada Pasien Anak di Bawah Umur 6 Tahun

“…Setelah rekomendasi (2007) tersebut, kunjungan pasien ke unit gawat darurat akibat efek merugikan berkurang menjadi setengahnya. 1,3,4 Beberapa perusahaan juga telah mengikuti rekomendasi tersebut dengan mengubah label produknya untuk tidak digunakan pada anak usia dibawah 4 tahun. Sedangkan American Academy of Pediatrics (AAP) merekomendasikan untuk tidak menggunakan obat batuk pilek yang dijual bebas pada anak usia di bawah 6 tahun.…”

Knowledge, Attitude and Practice of Measuring Devices of Oral Liquid Medications in the Population of District East Karachi, Pakistan

“…[11] Another medicine Clonidine suspension is mostly prescribed to children and the overdose of Clonidine in children has resulted in major clinical circumstances and lead to deaths. [12,13] According to FDA (Food and Drug Administration) calibration for measuring devices should be within value of ±5% which is assigned for Measuring Devices, Packaging, Medication Safety Containers. [14] …”