Navigation Links
FDA Says Tessalon Liquid Cough Capsules Pose Risk for Young Children
Date:12/14/2010

SILVER SPRING, Md., Dec. 14, 2010 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug's candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.

"Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "The FDA encourages health care professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose."

A review of the FDA's Adverse Event Reporting System database from 1982 through May 2010 identified seven cases of accidental ingestion associated with benzonatate in children younger than 10. Five of the cases resulted in death in children ages 2 years and younger. Overdose with benzonatate in children younger than 2 years has been reported following accidental ingestion of only one or two benzonatate capsules.

Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion.  

The FDA is also adding a new Warning and Precaution section to the benzonatate drug label to warn health care professionals about accidental ingestion resulting in overdose and death in children younger than 10.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of benzonatate to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

For more information:

FDA 101: Medication Errors

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048644.htm

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Innovative Clinical Solutions, Ltd. Announces Second and Final Liquidating Cash Distribution
2. AccuDial® Pharmaceutical Solves OTC Dosing Errors for Childrens Liquid Medications
3. American Oriental Bioengineering Introduces Wujia Rongxue Oral Liquid
4. NeurogesX Doses First Patient in Phase 2 Clinical Study of NGX-1998 Liquid Capsaicin Formulation
5. AMS Announces Worldwide Launch of the Revolutionary MoXy™ Liquid Cooled Fiber for Fast, Safe Treatment of Enlarged Prostate
6. Instrumentation Laboratory Introduces Fully Automated, Liquid, Ready-to-Use HemosIL® HIT-Ab(PF4-H) Assay in Europe
7. AMS Receives 510(k) Clearance of Its Revolutionary MoXy(TM) Liquid Cooled Fiber for Fast, Safe Treatment of Enlarged Prostate
8. University HealthSystem Consortium Selects Centurion Service Group for Equipment and Asset Liquidation Services
9. Renhuang Pharmaceuticals Announces Plans to Introduce Qing Re Jie Du Oral Liquid
10. Caliper Life Sciences Introduces Sciclone(R) G3 Liquid Handler
11. Bayer Consumer Care Voluntarily Recalls One Lot of Combination Package of Alka-Seltzer Plus(R) Day & Night Cold Formula Liquid Gels
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... p.m. (Eastern Daylight Time). As previously announced ... into a definitive merger agreement under which Jazz Pharmaceuticals ...
(Date:6/24/2016)... 24, 2016  Global Blood Therapeutics, Inc. (GBT) (NASDAQ: ... novel therapeutics for the treatment of grievous blood-based ... closing of its previously announced underwritten public offering ... public offering price of $18.75 per share. All ... by GBT. GBT estimates net proceeds from the ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
Breaking Medicine Technology:
(Date:6/26/2016)... Michigan (PRWEB) , ... June 26, 2016 , ... On ... as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle ... honor of the city’s history as home to some of the world’s leading providers ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users can ... CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn ... X . Simply select a ProHand generator and drag it above media or text ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
Breaking Medicine News(10 mins):