Drugmakers Voluntarily Withdraw Infant Cough Medicines
Posted on: Monday, 15 October 2007, 06:00 CDT
Manufacturers of over-the-counter cough medicines in the US are voluntarily withdrawing oral cough and cold medicines that refer to infants after cases of misuse were reported.
The voluntary recall affects medicines made by Johnson and Johnson, which markets Tylenol, and Wyeth, which makes Dimetapp and Robitussin. The recall only affects medicines labeled for infants, not those intended for use in children age two years and older.
"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda Suydam, president of the Consumer Healthcare Products Association (CHPA).
"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."
The CHPA and its member companies recommended 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 two years.
According to the FDA, which is planning to discuss the safety and effectiveness of cough and cold drug product use in children, some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used.
Source: Datamonitor
Related Articles
- Help Boost Your Body's Defense Against Coughs, Colds and the Flu With New Patented vitamingum(TM), Nutrient-Enhanced Chewing Gum
- American Academy of Pediatric Dentistry Releases New Perinatal and Infant Oral Health Guidelines
- Honey Effective Against Cough in Children
- Safe and Reliable Cough, Cold and Flu Medicine for Children Still Available on Shelves
- CVS/Pharmacy to Remove OTC Infant Cough & Cold Products From Its Stores As Part of CHPA's Voluntary Withdrawal
- Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines
- Get a Detailed Picture of the Cough, Cold and Allergy (Hayfever) Industry in Ireland
- Common Medicines 'Can Harm Children Through Overdosing'
- Understand the Competitive Environment Within the Cough, Cold and Allergy (Hay Fever) Remedies Market in Japan
- Cold Drugs Go Behind Counter? Measure in Congress Would Limit Access to Key Meth Ingredient
 |
 |
User Comments (0)
RSS Feeds