Saturday, March 01, 2008

Are cold medicines linked to seizures?

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.


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.

Drug manufacturers responded in three ways:

• Just before the hearings, they pulled from the shelves 14 over-the-counter cold and cough medications for toddlers and infants. These included Dimetapp, Robitussin, Tylenol and Triaminic brands.

• They vowed to fight a ban on medicines for children 2 to 6.

• They promised to study the dosage of children's cold remedies. Dosage has been a concern because, without studies of the medicines in children, doctors have had to extrapolate from adult dosages -- a process that some doctors say does not work.

''There is no problem with these products if they're used at the recommended doses at the recommended intervals,'' said Linda Suydam, president of the Consumer Healthcare Products Association, the drug makers' trade group. ``We feel they are products that parents need and want, and so they should be on the market.''


Suydam argues that most problems stem from accidental ingestion or incorrect dosage.

''Problems could be dealt with through education,'' she said. ``We want to educate parents not to keep them where their children can reach them.''

Dr. Joshua Sharfstein, Baltimore's commissioner of health, disagrees. He co-authored a petition that led to the FDA hearings. He started the petition after four children died in six years in his city. ''In 2006 the [Maryland] state medical examiner attributed the deaths in part to overdoses of common cold medicines,'' Sharfstein said. ``The labeling is complicated, which causes inadvertent overdoses. If there was a real benefit, you could try to fix that problem by educating the public. But we're talking about a mild illness -- the common cold.

``Why take the risk?''

D.J. Mannello was born in Tampa on Oct. 20, 1998. At eight weeks, his father says, a case of near-pneumonia turned into a chronic thick, sticky mucus.

''The doctor said he's too young for a prescription, so just give him an over-the-counter medication,'' his father says. His mother says that, following the label's instructions, they asked their doctor what dose to give their son -- but she doesn't remember which doctor or what dose was recommended. D.J. was given the medicine over several months, she said.

At 16 months, D.J. suffered his first seizure. Dan Mannello says a doctor at All Children's Hospital in St. Petersburg told them a blood vessel in his son's left frontal lobe had burst. An MRI found scar tissue in his brain.

D.J.'s original diagnosis in 2000: dysplasia without focal point, the father says. (The doctor who made the diagnosis declined to be interviewed.) Dysplasia is defined as ''abnormal development or growth of tissues, organs, or cells.'' The ''without focus'' part means there's nothing concrete on which to operate to correct it.

In the same year as D.J.'s diagnosis, Mannello saw a segment on 60 Minutes about dozens of lawsuits against manufacturers of cold medicines, including over-the-counter medicines containing the ingredient phenylpropanolamine (PPA). Several cold medicine manufacturers voluntarily removed the ingredient after a May 2000 study for the FDA by Yale Medical School suggested it might cause brain hemorrhages. The Mannellos have a bottle of decongestant they say they gave to D.J. that lists that ingredient.

The lawsuits are ongoing, said Hiram ''Ted'' Carey, of Robinson & Cole in Boston, who is handling some of them. But none has come to trial, and the size of out-of-court settlements isn't known because of confidentiality agreements.

''The big question in the trials is this,'' Carey says: ``Did the PPA cause the injury? If you can't get an expert to say so, you have a big problem.''

Dan Mannello tried to join the lawsuits, but his doctors wouldn't give him a diagnosis on which he could base a lawsuit.

Still, Mannello soldiers on. He's working now with Gene Odom, a Tampa product liability lawyer.
Odom is pragmatic: 'Some doctors will tell you, `I cannot say what was the cause.' That will be the battle. We will have other doctors look at the records and see if they think the drug could cause this problem.''


D.J. is in third grade at Fuguitt Elementary in Largo, near St. Petersburg, enrolled in special classes for Individual Exceptional Personalities. It means no tests, no FCAT.

''He doesn't make it every day,'' his father says. ``But when he does he can run and play and laugh; he's a real hell raiser. He's very good at recognition, but he has a hard time communicating -- talking, writing.

``He gets hurt all the time. The school has me on speed dial. I can be there in five minutes.''

His mother goes on: ``He was having two or three seizures a day. He would start off across the floor and just fall on his face. It was hard to watch. He's had three or four broken noses, any number of goosebumps on his head, eight stitches in his skull, 10 in his leg; he has a scar on his forehead.''
Later in the day after his seizure in his father's office, D.J. is playing in the yard with his sister, Alexis, 12, and their dog, a ''refugee from the pound'' mixed-breed named Ellie. The house, a small ranch, is in foreclosure.

''It's been a battle. It's cost me my business, my house and my marriage,'' Mannello says.
In their most recent attempt to help D.J., the Mannellos took him to Resnik at Miami Children's.
''There's scarring in only one hemisphere,'' Resnik says. ``If it was from medication, it would be both hemispheres. We see scarring, but we don't know the cause.''

Resnick says D.J.'s diagnosis is probably ''dysplasia with focus,'' rather than ''without focus.'' It means there's something on which they can operate.

''We're excited,'' Mannello says of the March 13 surgery.

D.J.'s parents were divorced in 2000, but vow to keep on fighting for their son. They have joint custody, with D.J. living most of the time with his dad.

''The bitterness is gone now,'' says Mannello. ``We're just trying to do the best we can for D.J.''
''I hope he can overcome this,'' says his mother. ``I hope he can meet a girl and fall in love and have a home and a family. I'm sad and frustrated. We've tried so many things, but nothing seems to help him for very long.''


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