Cough medicines for infants recalled
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Manufacturers voluntarily recalled 14 medications, including Tylenol Concentrated Infant Drops and Triaminic Infant Toddler Thin Strips, products that are designed to be easy for young children to ingest but also could be confusing for parents trying to determine the correct dosage.
Some medications come in tiny droplet-size doses, but parents occasionally do not consult or follow directions from physicians, which can lead to an accidental overdose.
Some parents will not follow the frequency directions on the box and will give a drug more often then they should, said Brenda Darling, who oversees pharmacy services in the emergency room of Children's Medical Center Dallas.
It's very confusing when you have a sick baby, and you just want to do something to help him get better, said Ms. Darling, who also has a 21-month-old son. I get confused, too, and I'm a pharmacist.
A Food and Drug Administration review of cough medicine side effects between 1969 and September 2006 found 54 reported deaths in children associated with decongestant medicines and 69 reported deaths associated with antihistamine medicines.
A study this year revealed that more than 1,500 children younger than 2 had overdosed on cough and cold medications in 2004 and 2005 and that three infants younger than 6 months died two years ago.
Such deaths continue to be reported and underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medication to children under 2, concluded the January study by the Centers for Disease Control and Prevention.
While the manufacturers of such cold remedies continued to maintain that their products are safe and effective, they also acknowledged Thursday the risk of complications if misused.
These medications are and always have been safe at the recommended doses, said Linda Suydam, president of the Consumer Healthcare Products Association, which represents the companies. These voluntary actions are being taken out of an abundance of caution.
By Thursday afternoon, seven of the medications had been removed from the shelves at Walgreen Drug Stores in the Dallas area. In their place was a sign that said: This item has been recalled by the manufacturer. We apologize for the inconvenience.
Other stores in the area, however, were still selling the drugs.
Word of the recall was just reaching parents of young children, who acknowledged that they had struggled about what to do for a baby battling a bad cold. A visit to the pharmacy only added to their confusion, they said.
The labeling on these products is very confusing because it says 'infants medication,' but you're not supposed to give it to a baby without a doctor's approval, said Christy Abbott of Dallas.
I was confused when my son got sick last spring. I called the doctor and she said, 'Don't use that stuff.'
The problem becomes compounded when parents may give their children two medications meant to relieve various symptoms without realizing that both contain the same ingredient, which also leads to overdosing.
Ms. Darling, the pharmacist, said parents too often pressure doctors to prescribe a cold remedy or to allow them to buy something to relieve their babies' symptoms. Usually, the infants are brought to the emergency room after a long night of crying and coughing that has kept the parents awake and agitated.
I can understand that they've been up all night and they want help, she said. But cold medication is not recommended for children under 2 years of age. It hasn't even been shown to be effective.
Instead of using drugs, doctors often recommend that parents learn how to use a plastic suctioning bulb to relieve their babies' nasal congestion. The device suctions mucus from the nasal cavity, sometimes requiring several drops of saline solution or exposure to a dehumidifier to loosen the fluid.
Babies don't like it, Ms. Darling said of the suctioning. But parents with a sick baby can be taught to do it before every feeding and before they put the child down to sleep.
This week's recall comes as safety experts are pushing the federal government to ban over-the-counter and multi-symptom cough and cold medicines for children younger than 6. A panel of nongovernment experts will examine the medicines' safety records next week and recommend possible labeling changes.
An FDA review prepared for the Oct. 18-19 meeting described dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions from children using a variety of cough and decongestant medications.
Critics of such drugs note that the FDA has never recommended or even studied the proper doses of cough medicine for children younger than 2.
There is no evidence that the products actually work for young children, said Joshua Sharfstein, Baltimore's health commissioner and a leader in the effort to ban such medications for babies.
Inadvertent overdose is too common and potentially very unsafe.
The Associated Press and The Washington Post contributed to this report.
Recommendations for parents who have been using children's cold medicine:
With a coughing, crying, congested baby, try humidity, saline nose drops and lots of fluids to replace the over-the-counter medicines being taken off the market, doctors said.
Runny noses, sore throats, coughs and fever are best treated with fluids, humid air and doses of nonaspirin pain relievers appropriate for a child's age, said Ian Paul, a pediatrician who spoke on behalf of the American Academy of Pediatrics.
Some physicians recommend holding a sick baby in a steamy bathroom where hot water has been running. If the child's symptoms get worse or aren't better after three or four days, see a doctor.
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Related: Cough medicines for infants recalled
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