A new paper in the journal CHEST presents the case of a toddler who went into respiratory distress after receiving a smear of Vicks VapoRub under her nose. To figure out what happened, the researchers replicated the treatment in ferrets, whose respiratory systems are a good model for humans. The results were not exactly consistent with the Vicks “Breathe free” slogan:
[VapoRub] stimulates mucin secretion and [mucociliary transport] in the … inflamed ferret airway. This set of findings is similar to the acute inflammatory stimulation observed with exposure to irritants, and may lead to mucus obstruction of small airways and increased nasal resistance.
In an accompanying press release, the investigators elaborate:
“The ingredients in Vicks can be irritants, causing the body to produce more mucus to protect the airway,” said Bruce K. Rubin, MD, FCCP, the study’s lead author from the Department of Pediatrics at Wake Forest University School of Medicine, Winston Salem, NC. “Infants and young children have airways that are much narrower than those of adults, so any increase in mucus or inflammation can narrow them more severely.”
“I recommend never putting Vicks in, or under, the nose of anybody—adult or child. I also would follow the directions and never use it at all in children under age 2,” said Dr. Rubin. Even when directions are followed, VVR may make people with congestion feel more comfortable, but it does nothing to increase airflow or actually relieve congestion. “Some of the ingredients in Vicks, notably the menthol, trick the brain into thinking that it is easier to breathe by triggering a cold sensation, which is processed as indicating more airflow. Vicks may make you feel better but it can’t help you breathe better.” Dr. Rubin also feels that although the study only tested Vick’s VapoRub, similar products, including generic brands, could cause the same adverse reaction in infants and toddlers.
This news follows a recurring theme; the US Centers for Disease Control has highlighted the dangers of giving over-the-counter cough syrups to toddlers, and separate research has demonstrated that plain old honey is superior to those products anyway.
How did we get here? Aren’t Federal regulators all over drug makers? Didn’t Robitussin, Vicks, and similar products have to pass rigorous trials for safety and efficacy before getting to market? In a word, no.
The problem is that when our current drug regulatory system came into force, there was already a thriving drug industry, able to apply considerable leverage on politicians. A 1906 law reined in the free-for-all of 19th century patent medicines, but still didn’t require careful testing or set detailed manufacturing standards for drugs.
As often happens, some people had to get hurt to reveal the need for industry regulation. Twin disasters in the 1930s, one involving a barely legal Prohibition-era libation called Jamaica Ginger and the other a prescription antibiotic called Elixir Sulfanilamide(PDF), did the trick. The former left an estimated 30,000-50,000 people paralyzed or “Jake-legged,” while the latter killed at least a hundred. Congress was finally forced to act, and they expanded FDA powers enormously.
Jamaica Ginger Extract, image courtesy Wikipedia
There was a loophole, though. Medications that were already on the market, particularly over-the-counter remedies, were essentially “grandfathered” under the new regime. Taking its input from the industry, the agency published (and still publishes) monographs detailing formulations that are considered safe. Importantly, a product covered by an FDA monograph does not have to undergo the same rigorous testing as a genuinely new drug. Because the safety standards were written with adults in mind, they also don’t contemplate whether the monograph-covered compounds are safe for infants and toddlers.
Now, researchers are revisiting the safety and efficacy of these drugs, and reaching the unsurprising conclusion that some of them don’t work, and might not be entirely safe. Exactly the same thing often happens when products from the the multi-billion-dollar “supplements” industry get long-overdue testing. In both cases, we’re dealing with products that hit the store shelves before they hit the independent laboratory.
So what do you do if you or your kid catches a cold? Let it run its course, and stick to treatments we really know are safe:
“Cough and cold medicines and decongestants are dangerous and neither effective nor safe for young children. Medications to dry up nasal passages also have problems,” said Dr. Rubin. “The best treatments for congestion are a bit of saline (salt water) and gentle rubber bulb suction, warm drinks or chicken soup, and, often, just letting the passage of time heal the child.” Dr. Rubin also notes that if a child is struggling to breathe, it is a medical emergency and would require the child to be seen by a doctor as quickly as possible.