Navigation Links
Drug Makers Withdraw Cough, Cold Meds for Infants
Date:10/11/2007

Move comes as U.S. regulators scrutinize safety of products linked to dozens of deaths

THURSDAY, Oct. 11 (HealthDay News) -- Leading drug makers announced a voluntary withdrawal Thursday of oral cough and cold medicines marketed for use in infants.

The move affects only "infant" oral medicines, not those intended and labeled for use in children age 2 and older. And it comes as U.S. regulators review the products' safety, following reports of dozens of deaths since 1969.

"The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority," Linda A. Suydam, president of the Consumer Healthcare Products Association (CHPA), said in a prepared statement.

According to the CHPA, the cough and cold medicines that are being withdrawn are:

  • Dimetapp(R) Decongestant Plus Cough Infant Drops,
  • Dimetapp(R) Decongestant Infant Drops,
  • Little Colds(R) Decongestant Plus Cough,
  • Little Colds(R) Multi-Symptom Cold Formula,
  • PEDIACARE(R) Infant Drops Decongestant (containing pseudoephedrine),
  • PEDIACARE(R) Infant Drops Decongestant & Cough (containing pseudoephedrine),
  • PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine),
  • PEDIACARE(R) Infant Dropper Long-Acting Cough,
  • PEDIACARE(R) Infant Dropper Decongestant & Cough (containing phenylephrine),
  • Robitussin(R) Infant Cough DM Drops,
  • Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant,
  • Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant Plus Cough,
  • TYLENOL(R) Concentrated Infants' Drops Plus Cold,
  • TYLENOL(R) Concentrated Infants' Drops Plus Cold & Cough.

Last month, U.S. health experts urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children. The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to FDA documents.

An FDA advisory panel is scheduled to consider the recommendation during a meeting on Oct. 18 and 19, and will then offer an opinion to the full agency. The FDA typically follows the recommendations of its advisory boards but is not required to do so.

In the safety review released Sept. 28, the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, The New York Times reported.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine, the Associated Press reported.

Most of the deaths were children younger than 2.

The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, said it and its member companies have put forth recommendations to the FDA to strengthen the labels on all oral OTC children's cough and cold medicines from "ask a doctor" before using to "do not use" in children under 2 years of age.

More information

To learn more about the voluntary withdrawal, visit the Consumer Healthcare Products Association.



SOURCES: Oct. 11, 2007, prepared statement, Consumer Healthcare Products Association, Washington, D.C.; Sept. 28, 2007, U.S. Department of Health and Human Services report, The Food and Drug Administration's Oversight of Clinical Trials; The New York Times; Associated Press


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Researchers identify the early makers of Neonatal Sepsis
2. Epilepsy Patients Could Benefit From Pacemakers
3. Withdrawal Notice Issued For Older Pacemakers Due To Malfunctioning of the Device
4. Stem Cells Could Replace Electronic Pacemakers
5. Lawmakers alerted on new tobacco control policies by research team
6. Chocolate makers to be health wise and urge consumers to be too!
7. Drug Makers Banned From Providing Gifts To Doctors
8. Lawsuit Against Sunscreen Makers For False Claims of Protection Against Skin Cancer
9. Sensing The Health Hazard MP3 Makers Tone Down The Volume
10. Reliability of Pacemakers and Defibrillators to be Improved
11. Food Makers Pressurized to Reduce Salt
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2017)... ... July 24, 2017 , ... Axiad IDS , a leading provider of ... with WALLIX to expand its solution to help government contractors more quickly ... number of ways to address the authentication requirements within NIST SP800-171, but no ...
(Date:7/24/2017)... , ... July 24, 2017 , ... ... fat (adipose) transfer systems announces the issuance of United States Patent Number 9,695,398 ... its adipose filtration technology. The '398 and '324 patents cover methods and ...
(Date:7/24/2017)... ... July 24, 2017 , ... ... solution focused on delivering end-to-end sleep health care at scale, indicates record-breaking ... shows that adherence rates for positive airway pressure (PAP) therapy, the most widely ...
(Date:7/24/2017)... ... July 24, 2017 , ... Committed to eliminating clubfoot as ... 100,000 children in their treatment program. Clubfoot is a pervasive problem in the ... is limited or non-existent. Without intervention, these children are destined to grow up ...
(Date:7/24/2017)... ... 24, 2017 , ... On July 19th, the Chinese Academy ... the awarding ceremony was held successfully in Beijing. The State Health Planning Commission, ... system, and national Chinese medicine experts also attended the event, including more than ...
Breaking Medicine News(10 mins):
(Date:7/13/2017)... , July 13, 2017  New York City-based market research ... markets should be aware of.  From new products to new ... detailed in a recently completed study, Potential Pipeline Disruptors ... 1.  Age-Driven Growth - True ... been aware of the impact the growing population and, to ...
(Date:7/12/2017)...  Eli Lilly and Company (NYSE: LLY ) ... resolve pending patent litigation in the U.S. District Court for ... the Cialis ® (tadalafil) unit dose patent. This patent ... part of the agreement, Cialis exclusivity is now expected to ... "The unit dose patent for Cialis is valid and infringed ...
(Date:7/11/2017)... July 11, 2017  Bayer has awarded grants totaling more ... part of its prestigious Bayer Hemophilia Awards Program (BHAP). Four ... Philadelphia and Uniformed Services University of the ... the winners. Grant recipients were announced last night during a ... 2017 Congress, Berlin, Germany . ...
Breaking Medicine Technology: