1lost1
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Drug Companies Pull Infant Cold Medicine
Drug Companies Pull Infant Cold Medicines
Major Drug Makers Voluntarily Pull Products Following Gov't Warning
CBS News Interactive: About Your Health
(CBS News) WASHINGTON Drug makers pulled cold medicines targeted for babies and toddlers off the market Thursday, leaving parents to find alternatives for hacking coughs and runny little noses just as fall sniffles get in full swing.
The move represented a pre-emptive strike by over-the-counter drug manufacturers - a week before government advisers were to debate the medicines' fate. But it doesn't end concern about the safety of these remedies for youngsters.
Thursday's withdrawal includes medicines aimed at children under age 2, after the Food and Drug Administration and other health groups reported deaths linked to the remedies in recent years, primarily from unintentional overdoses.
In a statement, the drug manufacturers essentially blame parents for the overdosing children, citing "rare patterns of misuse leading to overdose," reports CBS News correspondent Wyatt Andrews.
“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 industry trade group.
The American Academy of Pediatrics disagrees. It said, in general, the drugs shouldn't be used for colds in small children.
“This is not a situation in which pediatric data are lacking and we are unable to say one way or the other,” Dr. Jay Berkelhammer, the academy's president, wrote the FDA last month. In multiple studies, they have “been found not to be effective in this population at all.”
Next week, the FDA will consider the possibility of banning these medicines for all children under 6, reports Andrews. Consumer groups say the industry is giving up the infant market in order to keep the rest of the under-6 market.
The FDA is reviewing the safety of cold medicines at the request of Baltimore health commissioner Dr. Joshua Sharfstein and other city officials who reported 900 Maryland children under the age of 4 overdosed on the products in 2004.
"I'd like to think they saw the evidence that the products are not safe and effective and they're doing the right thing," Sharfstein told CBS News' Barry Bagnato. "But we'd like to see broader action because we think the evidence justifies that, as well."
Baltimore city officials were joined by the American Academy of Pediatrics and prominent pediatricians around the country in their petition, which argued that oral cough and cold medicines don't work in children so young, and pose health risks not just for babies but for preschoolers, too.
Scientists inside and outside the FDA have concluded that cough and cold formulations have never been shown to work in children under six years old, reports Andrews. Worse, overdoses of these cold formulas led to the deaths of 123 children between 1969 and 2006.
“Pediatricians are taught these products don't work and may not be safe. Yet almost every parent uses them,” said Dr. Joshua Sharfstein, Baltimore's health commissioner and a pediatrician, who blames ads that overpromise relief.
The challenge, he says, will be to convince parents to try old-fashioned methods, like suctioning out infants' noses or using salt-water nose drops.
“If you can actually pull a booger out with a suction device, people can feel better,” Sharfstein said.
The Consumer Healthcare Products Association announced Thursday that manufacturers were voluntarily ending sales of over-the-counter oral cough and cold products aimed at infants. The list includes infant drops sold under the leading brand names Dimetapp, Pediacare, Robitussin, Triaminic, Little Colds, and versions of Tylenol that contain cough and cold ingredients.
CVS Caremark Corp. added that it would also end sales of CVS-brand equivalents.
Lark Hackney of Anchorage, Alaska, said her two grandchildren, 1-year-old Taylor and 2-year-old Julius have had many colds.
“We go to the doctor if it's gucky and it lasts very long, but a lot of times we just treat it with, you know, treat the symptoms” like fever or cough with children's medicine over the counter, said Hackney, who was at the National Zoo in Washington with her grandchildren.
She said they have used children's cold medicines and neither child has had a bad reaction.
The FDA is bringing its scientific advisers together Oct. 18-19 to debate the issues, but its own preliminary review concluded that very young children shouldn't take some of these commonly used medicines. And while the FDA's main focus is on children under 6, it also will ask if there's evidence that these drugs work in children up to age 12.
FDA praised the drugmakers' withdrawals Thursday as important for protecting babies.
For other youngsters, parents should understand that cold remedies treat only symptoms, they don't make viruses go away any faster, stressed FDA pediatrician Dr. Dianne Murphy, who urged parents to consult their pediatricians.
“What's the risk? That's what this whole meeting is about,” she said. “You need to weigh 'Is that symptom that important to treat?'"
Most coughs shouldn't be suppressed - that's how the body clears the lungs, she added. Low-grade fevers are how the body fights infection.
Maureen Javers of Silver Spring, Md., likes to let colds play out unless a doctor says her children, 3-year-old Declan and 1-year-old Evelyn have an infection.
“I don't really like to medicate them if they don't need to have the medicine,” she said.
Health groups say that while low doses of cold medicine don't usually endanger an individual child, the bigger risk is unintentional overdose. For example, the same decongestants, cough suppressants and antihistamines are in multiple products, so using more than one to address different symptoms - or having multiple caregivers administer doses - can quickly add up. Also, children's medicines are supposed to be measured with the dropper or measuring cap that comes with each product, not an inaccurate kitchen teaspoon.
And, since “the medicine isn't doing what the family wants, instead of giving as directed every six hours they give every four hours or every two hours,” says Dr. Basil Zitelli of the Children's Hospital of Pittsburgh, who sees such children in the emergency room. “What they in effect are doing is poisoning their child.”
What to try instead? Pediatric and public health groups recommend:
Plenty of fluids and rest.
Suction bulbs to gently clear infants' clogged noses. Saline nose drops loosen thick secretions so noses drain more easily.
A cool-mist humidifier in the child's bedroom.
Acetaminophen or ibuprofen, as recommended by your doctor, to alleviate pain or discomfort - but check that they don't contain extra ingredients.
Some chest creams can ease stuffiness with menthol or other fragrances, but check labels for age restrictions.
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Mayhem of Motherhood
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Oct/11/2007, 8:39 pm
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suzidfloosey
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I have no problem with this - these meds while essential in some cases are overused and can result in complications. I always seem to be harping but good old fashioned nursing ie fluids, rest, good food etc will deal with the majority of coughs/colds. Two of ours have coughs at the moment, not bad enough to be off school but they are going to bed earlier this week and generally cutting back on activities and resting more. If it got worse they would be off school and in bed.
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Oct/12/2007, 6:46 am
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1lost1
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Livy has had a cold start over this weekend. Yesterday she coughed a bit ~ her nose though it what was the worst part of it. I couldn't keep up with it. So we went it looked for something hoping to alleviate the nose. No luck. I thought I understood the recall to be 2 years old and under, it is in fact for under 6 years of age. So I grabbed the stuff for Chicken Soup ~ I keep plenty of Liquids here so I had that covered and I put her hair in a ponytail.
I see why they did it. I also have to believe there was a specific ingredient concern so I tossed what we had here in the house for her. If the recall saves one babies life, in my eyes it was worth it.
The other side of it is though... It really is going to be difficult for those with no insurance to schedule and take their little one to the doctor when a cold gets nasty. The expense alone will keep many from seeking help. In the long run its going to cost more because those people usually wait, the sickness gets nasty and little one has to be taken to the emergency room. It will be a compromise too for many families... do they miss work to take little one to the doctor they can't afford and risk getting fired or do they just assume its a common cold and it will pass. Some employers only allow X of numbers of days to be missed.
As cold and flu season approaches and with all the little ones in school and daycare this time of year is going to be hectic and unfortunately expensive for so many families. I think we are going to find out there is a greater expense than what what realized.
Last patched up by 1lost1, Oct/21/2007, 9:00 am
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Mayhem of Motherhood
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Oct/21/2007, 8:56 am
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suzidfloosey
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Yes, i do understand that side of it lost. We always have one person at home so we're lucky that way but if you don't have an understanding employer it can be v.tough. There must've been a dodgy ingredient in them I think for them to be recalled.
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Anyone who lives within their means suffers from a lack of imagination.
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Oct/21/2007, 2:13 pm
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