Navigation Links
FDA Panel Weighs Ban on Kids' Cold Medicines
Date:10/18/2007

There's no proof they help children under 6, and they may do harm, critics say

THURSDAY, Oct. 18 (HealthDay News) -- Beginning Thursday, a panel of experts at the U.S. Food and Drug Administration will consider banning the sale of over-the-counter cough and cold medicines for young children.

Such a ban already has the support of safety experts at the FDA, who published a 365-page review on the issue in late September. Any recommendation from the advisory panel would apply to decongestant use in children under 2, and antihistamines in those younger than 6. While the FDA does not have to follow a panel's recommendation, it usually does.

According to the FDA safety review, decongestants and antihistamines have been linked with 123 pediatric deaths since 1969.

Many outside experts are also in favor of restricting children's access to cold remedies.

"The panel should recommend that the FDA carefully reevaluate their existing approval of cough and cold preparations being marketed to children under 6," said Dr. Michael Shannon, chief of the Division of Emergency Medicine at Children's Hospital Boston. "Our hope is that they will agree that it is not appropriate to market these products to children."

The products covered in the debate include approximately 800 popular medicines sold in the United States under names such as Toddler's Dimetapp, Triaminic Infant and Little Colds. Experts estimate that Americans spend about $2 billion annually on these types of medications.

Last Thursday, leading drug makers announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants.

That move affected only infant oral medicines, not those intended and labeled for use in children age 2 and older, Shannon noted. And it comes as U.S. regulators review the products' safety.

Shannon, who filed the original petition with the FDA in March and is testifying at the hearings, doesn't think that last week's recall by manufacturers goes far enough. The recall only affects children under 2 and not children between 2 and 5, who make up two-thirds of those taking the drugs, he said.

"They made an effort, but it was nowhere near far enough," Shannon said.

In addition, these cold products simply don't work, according to Shannon. "There is no reason to give something that costs money, is ineffective and has potential risks," he said.

Not only can these medications be dangerous, but studies have shown that they have no significant effect, the Boston expert said. "One can question what their effectiveness is in older children and even adults," Shannon said. "Across all ages, the scientific evidence for their effectiveness is very weak, and, for children under 6, the data are clear that they don't work."

Linda A. Suydam is president of the Consumer Healthcare Products Association (CHPA), which represents manufacturers of nonprescription medicines. In a statement, she said that, "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."

In a statement summarizing the group's expected testimony before the FDA committee on Friday, the CHPA defended both the safety and the effectiveness of over-the-counter children's cold medications.

"Both placebo-controlled and active comparator studies (eight in total) show these medicines are effective in reducing cough and cold symptoms in children," the CHPA stated. In addition, "in a recent national survey, 91 percent of parents using these products reported that these medications made them or their child feel more comfortable, and 89 percent of parents said OTC cough medicines helped their child cough less."

As for child safety, the CHPA said that "serious adverse events associated with over-the-counter cough and cold medicines are very rare," and are almost always caused by overdose, "which underscores the need for proper storage and safekeeping of these medicines."

But Shannon remains concerned. "These drugs interact with other drugs. These drugs have exaggerated effects on children who have other illnesses," he said.

And nothing conquers the common cold, he added.

"We have to accept the fact that there are no real treatments for the cold," Shannon said. "It's a mistake to think that there are medications that are really going to make a cold go away sooner or make the child feel much better. Medication for fever works, but these medications for cough suppression do not treat the common cold."

Another expert agreed with Shannon.

"Colds take a lot of time to nurture, and the medicines don't really speed up that process at all," said Catherine Tom-Revzon, the clinical pharmacy manager at Children's Hospital at Montefiore in New York City.

Tom-Revzon believes that rather than risking potential harm from these medications, it's better to remove them from the market.

For children with colds, Tom-Revzon recommends giving lots of fluids, using a misting humidifier and putting an extra pillow under the child's head to help drain fluids. "If the child has a high fever and doesn't want to eat or drink, something more serious may be going on, and the child should be brought to the doctor," she said.

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.

Most of the deaths involved children younger than 2.

On Sept. 28, the FDA announced that the makers of almost 200 unapproved prescription medicines containing the ingredient hydrocodone must cease making these products for children under 6 by Oct. 31.

Hydrocodone, a narcotic, is commonly used to ease pain and cough. According to The New York Times, many of the children's hydrocodone products currently on the market have been around for decades but never received approval from the modern-day FDA.

More information

For more on cold remedies for children, visit the American Academy of Pediatrics.



SOURCES: Catherine Tom-Revzon, Pharm.D, clinical pharmacy manager, Children's Hospital at Montefiore, New York City; Michael Shannon, M.D., M.P.H., chief, Division of Emergency Medicine, Children's Hospital, Boston; Oct. 18, 2007, statement, Consumer Healthcare Products Association, Washington, D.C.; Sept. 28, 2007, The New York Times


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

Related medicine news :

1. Panel suggests selling allergy drugs OTC
2. FDA panel refuses anti-viral cold remedy
3. Panel to Help Combat HIV/AIDS In Asia-Pacific Region
4. Expert panel confident of making AIIMS fully autonomous
5. Anti-Quota Stir: Resident Docs Demand Experts Panel
6. Circumcision Studies to Continue Says Health Panel
7. Breast Cancer Review Panel Adds Two Experts
8. Shingles Vaccine For Older People - Panel Recommendation
9. Complaints Against US Federal lab Over-ruled by Panel
10. E.U. Panel Backs Novartis Mock-up Pandemic Flu Vaccine
11. Generic Biologics – U.S Panel Hearing Draws Mixed Response
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... ... February 27, 2017 , ... Anahata ... Spiritual Awakening, is happy to announce her “Spring Rejuvenation in Sedona” personally ... individual customized retreats offer the winter-weary soul an excellent opportunity to come out ...
(Date:2/27/2017)... ... ... Orange County dentist, Dr. A. Rassouli, comments on the new ... bacteria in plaque infect the gums and other tissues supporting the teeth. Treatment typically ... SRP, and can include surgical therapies if the condition has led to significant damage. ...
(Date:2/27/2017)... ... February 27, 2017 , ... Texas based ... In addition, Discount Power's RCE (Residential Customer Equivalent) count exceeds 150,000. ... company had 800 customers and 2,250 RCEs at the time of acquisition. In ...
(Date:2/27/2017)... ... ... New Jersey ranks among the top five states in the entire nation ... advanced services is growing. , Project WE vs C is a focused two-year ... non-profit partners in their fight against cancer and in support of their shared mission ...
(Date:2/26/2017)... ... February 26, 2017 , ... NuevaCare, a leading home care ... Millbrae, Belmont, and Palo Alto, is proud to announce an important upgrade to its ... look for home care close to home, and by having city-specific pages, NuevaCare is ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... 2017 Research and Markets has announced the ... - Industry Forecast to 2025" report to their offering. ... The Global Wireless ... 23.8% over the next decade to reach approximately $330.5 billion by ... forecasts for all the given segments on global as well as ...
(Date:2/24/2017)... 2017 Research and Markets has announced the addition ... report to their offering. ... The latest research Hemophilia Drugs Price Analysis and Strategies - 2016, provides ... research answers the following questions: What are ... they positioned in the Global Hemophilia market? What are ...
(Date:2/24/2017)... 2017  In conjunction with DURECT Corporation,s (Nasdaq: ... release, you are invited to listen to a conference ... on Tuesday, March 14, 2017 at 4:30 pm Eastern ... audio webcast of the presentation will be available by ... "Investor Relations."  If you are unable to participate during ...
Breaking Medicine Technology: