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Child deaths lead to FDA hearing on cough, cold meds

  • Story Highlights
  • FDA: 54 reported child deaths from decongestants between 1969 and fall 2006
  • 69 child deaths from antihistamines in same period; most were under 2
  • Hearing starts Thursday on safety, effectiveness of cough, cold meds on kids
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By Jennifer Pifer
CNN
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BLOOMINGTON, Illinois (CNN) -- 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."

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Devon Mehlberg-Alvarez died at 4 months from an overdose of an ingredient in cough syrup.

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.

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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.

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." E-mail to a friend E-mail to a friend

Jennifer Pifer is a senior producer with CNN Medical News. Correspondent Elizabeth Cohen and managing editor Miriam Falco contributed to this report.

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