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Researchers: VapoRub Not For Young Children

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BY RICHARD CRAVER

MEDIA GENERAL NEWS SERVICE

Published: January 21, 2009

WINSTON-SALEM, N.C. - Vicks VapoRub ointment, the menthol compound created 118 years ago, has been used by millions of parents to relieve symptoms of cough and congestion in their small children.

Now a study by the Wake Forest University Baptist Medical Center is creating new debate about the safety of the over-the-counter medication.

Wake Forest Baptist researchers said that Vicks can create respiratory distress in infants and small children. Its menthol compound typically is used to relieve coughing and congestion through its medicated vapors.

The study appears in the January issue of Chest, the peer-reviewed journal of the American College of Chest Physicians.

Wake Forest Baptist researchers found that because the product can stimulate mucus production and airway inflammation, it can have severe effects on breathing in infants or young children because of the small size of their airways.

"I recommend never putting Vicks in, or under, the nose of anybody - adult or child," said Dr. Bruce Rubin, the lead author of the study and a professor in the pediatrics department at the Wake Forest-affiliated Brenner Children's Hospital.

Procter & Gamble Co., which markets Vicks VapoRub, said on its Web site that the salve is "the No. 1-selling product for ages 2 and up in the cold category."

The product has a warning on its packaging that a doctor should be consulted before any use for children younger than 2, said David Bernens, a spokesman for Procter & Gamble's health-care products unit. The packaging also warns that it should not be used near the nostrils.

Bernens said that VapoRub averages three adverse reactions per 1 million units sold.

"Multiple studies over three to four decades, involving more than 1,000 participants ages 1 month to 12 years have not shown any respiratory distress," Bernens said. "We don't see the conclusions that Dr. Rubin did regarding respiratory distress and excess mucus."

The Rubin-led study comes at a time when some consumer-health-advocacy groups are urging the U.S. Food and Drug Administration to restrict marketing of over-the-counter medications for young children.

Those groups want the FDA to put warnings on expectorants, nasal decongestants, antihistamines and combination cough-and-cold products that say they "have not been shown to be safe and effective for the treatment of cough and cold in children under 6 years of age."

Allan Coukell, the director of policy at PrescriptionProject.org, said the drug industry watchdog group is trying to raise awareness among parents that "just because a product is on a shelf doesn't mean it can be given to just anyone, including infants and small children."

Rubin said that the study "is not meant to be provocative, but to encourage the revisiting and rethinking of therapies and the potential overuse of medicinal products." He said that there is little data supporting an actual clinical benefit of the salve.

"Cough and cold medicines and decongestants are dangerous, and neither effective nor safe for young children," Rubin said. "Medications to dry up nasal passages also have problems."

According to the study, Vicks has been reported to cause inflammation in the eyes, mental status changes, lung inflammation, liver damage, constriction of airways and allergic reactions.

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