Drug manufacturers said Tuesday that over-the-counter cold medicines should not be given to children under 4, acknowledging pediatricians' and health officials' concerns.

The Consumer HealthCare Products Association said labels saying ''do not use'' for children under 4 will be voluntarily affixed to over-the-counter pediatric cough and cold medicine packages. In addition, manufacturers will add labels warning parents not to use antihistamine products to sedate or make a child sleepy, the group said.

The warnings will be applied to mainstream medications -- Dimetapp, Tylenol, PediaCare, Robitussin and others. A Boston University study recently estimated 10 percent of all children use these cough and cold medicines in a given week.

''This is a significant step,'' said Dr. Joshua Sharfstein, the Baltimore health commissioner who petitioned the Food and Drug Administration to ban marketing cold and cough remedies to children younger than 6 after four children died in Baltimore from accidental overdoses since 1999. ``There is no data to show these drugs are safe and effective.''

Last October, shortly before the Food and Drug Administration was to begin on this matter, drug companies voluntarily pulled from the market over-the-counter cold and cough medicines aimed at infants and children younger than 2.

Shortly thereafter, the FDA warned that the medicines should not be given to children younger than 2. The agency received 54 reports of childhood deaths associated with over-the-counter decongestants and 69 reports of deaths due to over-the-counter antihistamines from 1969 to 2006, mostly in children 2 and younger.

The companies have maintained the products are safe but acknowledge there have been issues with doses given to children.

UM STUDY

A University of Miami study, to be published next month in the journal Pediatrics, underscores the confusion among parents.

In a study of nearly 200 parents of infants in Miami-Dade, Nashville, and Chapel Hill, N.C., the study found that two of three parents believed it was OK to give medication to a child younger than 2. The study was conducted from September 2006 to October 2007, when the drug makers had just announced their recall of products for infants.

''This was despite an FDA warning not to do so without consulting a physician,'' said Dr. Lee Sanders, the study's author and an associate professor of pediatrics at UM.

Sanders said the products' marketing messages -- pictures on the packages of infants and teddy bears -- led people to believe the medications were fine for children.

Problems with over-the-counter cough and cold medicines send some 7,000 children to hospital emergency rooms each year, with symptoms including hives, drowsiness and unsteady walking.

ADVERSE REACTIONS

Dr. Steven Lipshultz, dean of children's health at the University of Miami School of Medicine, said the problems stem not only from accidental overdoses but adverse reactions to the drugs' ingredients.

''These are not something that just relieve pain or can put you to sleep,'' he said. ``They contain stimulants that stimulate the heart. They can have an effect on sudden death syndrome, on how the heart mechanisms are controlled, on how breathing mechanisms are controlled.''

The FDA said last week the agency still needs to collect information before making a final ruling on whether the products should be banned for children younger than 6. The agency has been concerned that parents would turn to adult products for their children.

Meanwhile, the industry said parents should never:

• Give adult medicines to a child.

• Give two or more medicines with the same ingredients at the same time.

• Give antihistamines to make a child sleepy.

And parents should:

• Give the exact recommended dose, using the measuring device that comes with the medicine.

• Keep medicines out of sight and out of reach.

• Consult their doctors if they have any questions.

Sharfstein, the Baltimore health commissioner, puts it simply: ``Don't buy your child a cold or cough medicine. Buy them a book and cuddle up with them.''

Join the discussion

Note: If this is your first time using our NEW commenting system, you will have to LOG OUT and then LOG BACK IN.

The Miami Herald is pleased to provide this opportunity to share information, experiences and observations about what's in the news. Some of the comments may be reprinted elsewhere in the site or in the newspaper. We encourage lively, open debate on the issues of the day, and ask that you refrain from profanity, hate speech, personal comments and remarks that are off point. In order to post comments, you must be a registered user of MiamiHerald.com. Your username will show along with the comments you post. Thank you for taking the time to offer your thoughts.

     Showing: Oldest first Newest first Most-recommended first Least-recommended first

@Nyx.AuthorDisplayName@ wrote on @Nyx.PostedAtTime@:

@Nyx.CommentBody@

@Nyx.Recommender@ @Nyx.AbuseReporter@