CHILDREN'S MEDICINE
One man's quest
PULLED FROM THE SHELVES
Here are the 14 over-the-counter infant and toddler cough and cold medicines taken off the market by drug makers: Dimetapp Decongestant Plus Cough Infant Drops Dimetapp Decongestant Infant Drops Little Colds Decongestant Plus Cough Little Colds Multi-Symptom Cold Formula Pediacare Infant Drops Decongestant (containing pseudoephedrine) Pediacare Infant Drops Decongestant & Coug h (containing pseudoephedrine) Pediacare Infant Dropper Decongestant (containing phenylephrine) Pediacare Infant Dropper Long-Acting Cough Pediacare Infant Dropper Decongestant & Cough (containing phenylephrine) Robitussin Infant Cough DM Drops Triaminic Infant & Toddler Thin Strips Decongestant Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough Tylenol Concentrated Infants' Drops Plus Cold Tylenol Concentrated Infants' Drops Plus Cold & CoughSource: Consumer Healthcare Products AssociationBY FRED TASKER
ftasker@MiamiHerald.com
MADEIRA BEACH -- D.J. Mannello, 9, hops off the school bus, bounces into his dad's insurance office in this seaside town and settles into a chair.
''Hi, honey,'' says Roxanne, his mother. Seconds later, her face freezes.
''Dan,'' she tells D.J.'s father, ``he's having another seizure.''
The boy's bright eyes dull. His head droops. He can't speak. His parents take him into their arms.
His father kisses his forehead: ``You all right, bro?''
Dennis James Mannello isn't all right. Since he was 16 months he has suffered almost-daily seizures, been in and out of hospitals, back and forth to doctors, on and off medicines and diets.
''Nothing seems to help him for very long,'' says Roxanne.
Dan and Roxanne blame over-the-counter cold remedies they gave their son on doctors' recommendations starting when he was 8 weeks old, when a case of near-pneumonia turned into chronic, thick-mucus congestion. They persist in that belief even though D.J.'s doctors disagree, and say his problems might be congenital or caused by early injury, but not by over-the-counter cold medicines.
ON A MISSION
No matter. Since D.J.'s first seizure, his father has been on a mission to get the government to take children's cough syrup and cold medicines off the shelves. The mission has taken him to FDA hearings and put him on national TV. In January, there was a taste of victory -- the FDA warned that over-the-counter cold medicines should not be used in children under 2.
''Serious and potentially life-threatening side effects can occur from such use,'' the agency said in its public health advisory.
To Dan Mannello, 42, it wasn't enough: ``There are still medicines on the shelves. There are still hundreds of thousands of dosages in people's medicine cabinets.''
The search for D.J.'s treatment has gone through half a dozen doctors and hospitals -- most recently to Miami Children's Hospital, where D.J. was examined by Dr. Trevor Resnick, the hospital's chief of neurology and professor of neurology at the University of Miami School of Medicine.
Resnick, while reiterating that D.J.'s seizures were not caused by cold medicines, says preliminary results suggest that he might be helped by surgery. D.J. is scheduled to have brain surgery at the hospital on March 13.
''We're keeping our fingers crossed,'' Mannello says.
Through his persistence, Mannello was the only member of the public to testify in October before an FDA advisory panel on the safety of children's cold remedies.
''It's too late for my son,'' he told the hearing officials. ``But I don't want it to happen to anybody else. Please do the right thing and remove these drugs from the shelves immediately.''
ABC News interviewed Mannello outside the hearing room, and the interview appeared with anchor Charles Gibson on ABC's World News Tonight that evening.
The FDA hearings were based in part on a September 2007 report, which documented how the agency had received 54 reports of deaths associated with over-the-counter decongestants and 69 reports of deaths connected to over-the-counter antihistamines from 1969 to 2006 in children, mostly 2 and under. The Centers for Disease Control and Prevention reported last year that at least 1,500 children under age 2 have had serious complications from the medicines from 2004 to 2005, including three deaths.
The advisory panel voted to ban over-the-counter cold products for children under age 6. Panel members said there was no proof the drugs helped children, and some evidence they caused damage. The FDA subsequently issued its public health advisory in January, warning the medicines not be given to children under age 2, the group most vulnerable to potential harm, studies show. The FDA is studying the issue for children between 2 and 6.
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