FDA ADVISERS: NO COLD MEDS FOR THE YOUNG
By Andrew Bridges
Associated Press
October 19, 2007
Original LinkWASHINGTON - Widely used cold and cough medicines have not been shown to work in anyone younger than 12, government health advisers said Friday, in urging the over-the-counter drugs be studied directly in children.
"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the Food and Drug Administration experts gathered to examine the medicines, used billions of times a year to treat common cold symptoms.
The final recommendations are likely to lead to a shake up in how the medicines -- sold for decades without much scrutiny -- are labeled, marketed and used. The Thursday-Friday meeting came just a week after the drug industry moved to eliminate sales of the nonprescription drugs targeted at children under 2.
Pediatricians pushing for greater restrictions told the FDA advisers Thursday that the over-the-counter medicines shouldn't be given to children younger than 6, an age group they called the most vulnerable to any potential ill effects.
The 22 voting panelists were to recommend later Friday if the drugs simply shouldn't be used in some age groups. The FDA isn't required to follow the advice of its panels of outside expert but does so most of the time.
The drug industry says the medicines, used 3.8 billion times a year in treating cold and cough symptoms in children, do work and are safe. It argues that more parent education is needed to avoid overdoses that in rare cases have been fatal.
A group of pediatricians petitioned the FDA earlier this year seeking action on the medicines. The FDA called the meeting to answer a basic question: Are the medicines safe and do they work in the very young?
An American Academy of Pediatrics official told the experts the medications should be relabeled to tell parents they don't work in children under 6 and may be dangerous.
"Why not label these products with what we actually know?" asked David Bromberg, a Frederick, Md., pediatrician.
Some of the drugs -- which include Wyeth's Dimetapp and Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic products -- have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel.
An FDA review found just 11 studies of children published over the last half-century. Those studies did not establish that the medicines worked in those cases, according to the agency.
For the most part, the results from tests in adults have been extrapolated to determine whether the medicines work in children. But even that evidence is "modest at best," said panel chairwoman Dr. Mary Tinetti of Yale University School of Medicine. Indeed, all but one of the 22 panelists then voted to say that extrapolation is unacceptable.
The panelists later voted unanimously to recommend the medicines be studied in children directly to determine whether they work. That recommendation would require the FDA to undertake a rule-making process to reclassify the medicines, since the ingredients they include are now generally recognized as safe and effective, which doesn't require testing. That process can take years, even before any studies themselves get under way.
Simply relabeling the medicines to state they shouldn't be used in some age groups could be accomplished more quickly, FDA officials said.
Later Friday, the panel also was to examine whether the dizzying array of medicines that combine multiple ingredients and the sometimes hard-to-use droppers included in the packaging contribute to parents unwittingly overdosing their children. Some in the FDA recommend doing away with the combo products and requiring better-designed and standardized dosing devices.
One health expert told the panel that children catch five to eight colds each year. The frequent and normal symptoms of those colds don't necessarily require treatment beyond comfort measures that don't involve drugs, said Patricia Jackson Allen, of the National Association of Pediatric Nurse Practitioners.
"Watchful waiting for the normal body defenses to restore health is an appropriate and safe management strategy for the healthy child with the common cold," said Jackson Allen, adding that treatment can mask the symptoms of more serious ailments like asthma.
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CHILD DEATHS LEAD TO FDA HEARING ON COUGH, COLD MEDS
By Jennifer Pifer
CNN
October 17, 2007
Original LinkBLOOMINGTON, ILLINOIS - On a recent chilly Illinois morning, Dimitria Alvarez sat at her kitchen table and looked through her son Devon's baby clothes. "He was just so happy all the time," Alvarez remembered later with a smile. "He was so much calmer than my girls."
Devon Mehlberg-Alvarez was Alvarez's firstborn -- and her mother's first grandchild. When he was 4 months old, Devon got a cold. Alvarez took him to the doctor. The doctor told her to give Devon an over-the-counter infant cold and cough medicine. Alvarez followed the doctor's directions and gave Devon the suggested amount.
However, a few mornings later when the Bloomington, Illinois, mother checked on her son, something was wrong. "I screamed," says Alvarez, "He wasn't breathing. He was cold."
Devon was dead.
Deborah Mehlberg found out her grandson was dead after returning from a weekend trip. When she pulled into her driveway, her family was standing in the front yard. Her son told her the terrible news. "My heart fell out of my chest. I couldn't believe it," says Mehlberg. "No one in my family ever died this way." She needed answers.
At first, investigators blamed SIDS for Devon's death. But Mehlberg and her family were not convinced, so they pushed for more tests. "I'm a technical person," says Mehlberg. "I know that there's a cause and effect for everything, and I knew that there was something that caused this baby to die."
A few months later, the results came back. The cause of death: Dextromethorphan intoxication. Devon's family says they were told later that Devon's body could not metabolize one of the key ingredients found in many infant cold and cough medicines.
Over the past two years, 1,500 babies and toddlers have wound up in emergency rooms after having a bad reaction to cold medicines, according to the U.S. Centers for Disease Control and Prevention.
On Thursday, the Food and Drug Administration will meet to discuss whether over-the-counter cold medicines are safe and effective in children age 6 and under. Earlier this year, the FDA completed a review that found between 1969 and the fall of 2006 there were 54 reported child deaths from decongestants and 69 from antihistamines. Most of the deaths occurred in children under 2. Baltimore Health Commissioner Dr. Joshua Sharfstein headed the push that led to the FDA hearing. He became alarmed when four Baltimore children died after their parents gave them excessive doses of cold medicines. "I didn't quite realize that it could potentially be a life-and-death issue," says Sharfstein.
In August, federal health officials recommended the "consult your physician" advice to parents on the labels of cold and cough medicines aimed at young children be replaced by a warning not to use the medications in children under 2 unless directed to do so by a health care provider.
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Last week, in advance of the hearings, some of the leading manufacturers of cold and cough medicines announced a voluntary recall of more than a dozen cold medicines for infants. The Consumer Healthcare Products Association said the products were being pulled "out of an abundance of caution."
Potential misuse of the medications, not product safety, is driving the voluntary withdrawal, the group said.
In a written statement, the group's president, Linda Suydam said, "It is important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately."
The recall "in no way affects our taking this issue to the advisory committee meeting," said Dr. Joel Schiffenbauer, deputy director for the FDA's Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, Center for Drug Evaluation and Research. "All potential actions are on the table," he said.
Sharfstein says the industry must go further. He wants the FDA to ban the use of cold and cough medicines in children under age 6. "There's no evidence that they actually work," he says. In a statement on its Web site, the American Academy of Pediatrics states "No well-controlled scientific studies were found that support the efficacy and safety of narcotics (including codeine) or dextromethorphan as antitussives in children. Indications for their use in children have not been established."
Since Devon's death, his grandmother has been on what she calls a "one-woman crusade." "I'm the nut that walks up to people in the grocery stores and asked them if they have ever heard of this." says Mehlberg. From her home in a quiet Bloomington neighborhood, Mehlberg says she e-mailed comments to the FDA and will be watching what happens at the hearings closely.
During a recent trip to Devon's grave, Mehlberg received word of the voluntary recall. "Oh thank God," she said with tears in her eyes. "I never want another family to go through what we have."