Jan. 13, 2009— -- Dr. Bruce Rubin, has seen a lot of puzzling cases of respiratory problems. But Rubin, the vice chair of pediatric pulmonology at Wake Forest University Medical Center in Winston-Salem, N.C., said he had never encountered anything quite like the case he saw about three years ago.
An emergency room physician consulted Rubin when an 18-month-old girl who had a common upper respiratory infection suddenly developed severe breathing problems.
"The patient was disproportionately ill for having just an upper respiratory infection," Rubin said.
According to a case report published in the journal Chest by Rubin and his colleagues, the child was recovering relatively well while battling her respiratory infection until about two hours before she was admitted to the emergency room.
When doctors began questioning the patient's grandparents about what might have caused the girl's respiratory distress, the only answer her grandparents could come up with was that they had rubbed Vicks VapoRub under the child's nose earlier that day.
"Sure enough, we demonstrated that the Vicks produced increased mucous in the patient's airway, which was already inflamed and narrowed because of her respiratory infection," Rubin explained.
To confirm that the menthol-containing rub was responsible for the patient's respiratory stress, researchers tested the product on ferrets. Indeed, they found that exposure to VapoRub increased mucous production, thereby causing inflammation in the rodents' airways.
Rubin said this case should not be viewed as an isolated incident. Although the labeling on Vicks VapoRub indicates that the product should not be used on children younger than 2 and should not be rubbed directly under the patient's nose, he said some parents may still be putting young children at risk by not paying heed to these warnings.
"I don't think that parents ignore this warning, but I think they feel relief when they use [Vicks VapoRub] themselves, and it's an over-the-counter drug ... and, therefore, not thought of as anything that can cause problems," Rubin explained. "But sick children may respond differently than you'd anticipate."
VapoRub Soothes, But May Not Help
Although VapoRub is widely used to relieve cold and flu symptoms, there is little to no data suggesting that the product actually helps clear airways. This new study provides the first findings that suggest not only that the product doesn't help cold and flu patients, but that it may actually cause harm to some.
VapoRub has been known as a mainstay in many family medicine cabinets for years. In the past five years alone, Procter & Gamble shipped one billion units of the product globally.
According to Procter & Gamble spokesperson David Bernens, the market surveillance data obtained by the makers of Vicks does not coincide with the findings of this report. Bernens said they see only about three adverse events per one million units of Vicks VapoRub sold.
"For generations Vicks has been shown to be safe and effective if used in accordance with the instructions on the bottle," Bernens said. "Animal findings have unknown clinical relevance, and the safety of Vicks VapoRub has been shown in multiple clinical trials in over 1,000 children who were studied, ranging in age from one month old to 12 years old."
Still, most doctors said they don't recommend the widely-used remedy to patients.
"I don't suggest using VapoRub for any medical condition," said Dr. Curtis Stine, professor and associate chair in the Department of Family Medicine and Rural Health at the Florida State University College of Medicine. "If a patient or parent asks about it, I generally tell them that though lots of people use VapoRub, I'm not aware of any studies that say it helps. I suspect now I will caution people that it's been shown to potentially be harmful."
Other doctors said the study may even cause VapoRub to be lumped in with other cough and cold medications that the Food and Drug Administration (FDA) deemed unsafe for children under the age of 2.
According to Dr. Diane Pappas, associate professor of pediatrics at the University of Virginia in Charlottesville, this study confirms that Vicks VapoRub, too, "should not be used in children under the age of two."
However, recommendations to skip the Vicks may seem strange to many parents who were treated with it when they were children. These parents likely view Vicks as a harmless remedy rather than a potent medication that should not be administered to young children.
"You have a generation of young adults and even their parents who used Vicks on themselves, so they are familiar with it," said Dr. Ira Rubin, a pediatrician at Naperville Pediatric Associates in Naperville, Ill. "In addition, the general feeling is that since you are not ingesting a chemical, what harm could it possibly cause?"
VapoRub Complications Likely Rare
The good news is that the incidence of serious adverse events, such as respiratory distress, is quite low.
"Rarely do I hear people say their child suddenly got worse with VapoRub," said Dr. Neil Herendeen, director of the Strong Pediatric Practice at the University of Rochester Medical Center.
However, Dr. Richard O'Brien, spokesperson for the American College of Emergency Physicians, notes it is not uncommon to see similarly-caused breathing problems in people admitted to the ER.
"We do commonly see people with difficulty breathing due to noxious aromas, or contact with chemicals that can irritate the mucous membranes of the nose and mouth or even the lungs themselves," O'Brien explained.
O'Brien also noted that, based on the ingredients of the Vicks VapoRub, it is not hard to imagine how such a product could cause respiratory distress in a sick child.
"Looking at the ingredients of the product, if applied directly to the nostrils, it could be very irritating to the ... mucous membranes, and that can easily cause difficulty breathing in anyone, especially someone who is ill," O'Brien added.
And Dr. Ira Rubin said that the best advice may be to avoid cough and cold medications, such as Vicks in young children altogether.
"This is another reminder to parents to leave their infants alone," Rubin added. "Infants should not be exposed to chemicals and drugs unless absolutely necessary."