# Presentation: 656090

## Testimony on OTC Cough and Cold Products October 2, 2008

- Janet R. Serwint, MDProfessor of Pediatrics
- Johns Hopkins University
- School of Medicine

## Question 2

- Should cough and cold products for the pediatric population continue to be available OTC, or should they be made available only by prescription?

## Case- August 2008

- 2 month old infant
- Acute life threatening event
- Hospitalization in PICU
- Received Robitussin DM 1⁄4 tsp every 8 hours
- Recommended by pharmacist

## Measuring Device

## Calculation of “Correct” Dose for 2 Month Old  

| Preparation | Conc. | “Correct”Dose in 2 month old.  (% of tsp) | Resultant
Overdose with 1⁄4 tsp (mg dose) |
| --- | --- | --- | --- |
| Robitussin Cough Long Acting | 15mg/5ml. |    (0.33 ml)
     6.6 % |       4x |
| Robitussin Pediatric Long Acting | 7.5mg/5ml. |   (0.67 ml) 
    13.3% |       2x |
| Other Generic non-prescription |  |  |  |
| Silphen DM | 10mg/5ml. |    (0.5 ml)
     10% |       2.5x |
| Delsym Extended | 30mg/5ml. | (0.17 ml) 
     3.3% |        8x |

## Unexpected Infant Deaths Associated with Recent Cough/Cold Medication

| Location | #Deaths | Ages of Children | Time Period |
| --- | --- | --- | --- |
| AZ State Fatality Board1 | 10 | 17 days – 10 months | 2006 |
| Montgomery County OH Coroner2 | 10 | 1-12 months | 8 months |

- Rinsza ME  *Pediatrics* 2007
- Marenethi L. *J. Anal Tox* 2005

## American College of Chest Physicians- Clinical Practice Guidelines

- “In children with cough, cough suppressants and over the counter cough medicines should not be used as patients, especially young children, may experienced significant morbidity and mortality.”
- “Currently available cough suppressant therapy is severely limited by a dearth of effective agents and their unacceptable side effects.”
- 	-Irwin RS, *Chest*, 2006

## Accidental and Non-Accidental Poisonings as a Cause of Apparent Life Threatening Events

- 274 patients identified
- Symptoms of acute life threatening event (ALTE)
- Met NIH definition
- 4.7% positive tox screen for OTC cough/cold medications
- None of parents had acknowledged giving med
- 	-Pitetti RD, *Pediatrics,* 2008

## Adverse Events from Cough and Cold Medications in Children

- National Electronic Injury Cooperative Drug Event Surveillance
- Data from 63 US hospitals
- January 1, 2004- December 31, 2005
- ED visit attributed by physician due to cough/cold meds
- Children < 12 year
-      -Schaefer MK, *Pediatrics* 2007

## Adverse Events from Cough and Cold Medications in Children

- Estimated 7091 patients treated for adverse events from cough/cold medications
- Accounts for 5.7% of all ED visits fro adverse events for medications
- 	-Schaefer MK, *Pediatrics* 2007

## Adverse Events by Age 

- 23%

- 64%

- 13%

- Schaefer, MK  Pediatrics 2007

## Slide 13

## Potential Toxicity from Cough/Cold Meds

- Lethargy
- Irritability
- Tachycardia
- Hypertension
- Cardiac arrythmias
- Acute psychotic reactions
- Respiratory depression
- Acute life threatening events/apnea
- Death

## Conclusions

- Cold is a mild, self limited illness
- No known efficacy for cough/cold medications for children < 6 years
- There is significant morbidity and mortality
- Current data underestimates the morbidity and mortality
- Any death is an unacceptable risk

## Conclusions

- 	Urge the FDA to mandate withdrawal of cough and cold medications for children younger than 6 years of age.

## Slide 17

## Toxicity of Over the Counter Cough and Cold Medications

- Gunn VL, Taha,SH, Liebelt EL, Serwint JR
- 3 year old-lethargy and hypertension
- Observation in PICU,
- parental report of med: dimetapp
- 3 year old- persistent tachycardia
- R/o cardiomyopathy,
- Parental report of med: acetaminophen
- 9 month old-fever, lethargy, tachycardia, hypertension
- Return in cardiorespiratory arrest
- 	-*Pediatrics*, 2001