I can buy it over the counter, doesn’t that mean it’s safe?

That’s what most of us believe. After all, the FDA watches over the pharmaceutical industry to ensure the safety of whatever we find on the drug store shelves, doesn’t it? No pharmaceutical company is allowed to market a drug they don’t know to be effective, right?

Well, a group of pediatricians in my home town (Baltimore, MD), didn’t believe that. Led by Baltimore's health commissioner, Dr. Joshua M. Sharfstein, these pediatricians petitioned the FDA to stop the sale of cough and cold medications for children younger than 6, saying that there are no data showing that the drugs actually work and there is growing evidence that they pose a risk of serious harm.

As reported in The Washington Post, The Baltimore Sun, and countless other news outlets, cough and cold medications marketed for infants were pulled from store shelves this past week. Is that because these drugs aren’t safe? Or might there be some other reason for this action?

Well… let’s talk about safety before we address the motive behind this “voluntary” withdrawal of product from the market.

In the past 6 years, 4 infants in Baltimore have died because of these medications. Two weeks ago, the FDA released a report that there were 54 deaths in the United States from 1969-2006 involving decongestants and 69 involving antihistamines. Most were in children younger than 2. In 2005, the U.S. Toxic Exposure Surveillance System, a national database of poisoning cases, recorded up to 88,000 calls about juvenile overdoses or adverse reactions to cough and cold medicines and antihistamines. That’s a lot of overdoses and adverse reactions to medications that treat the symptoms of otherwise minor infections. And 123 deaths over 7 years is unacceptable for cold medicine. If these drugs were treating life-threatening conditions like cancer, this would be OK, but who wants their child to die over a runny nose?

So… the big question is this: has the pharmaceutical industry spontaneously decided to stop selling a potentially dangerous product that doesn’t work? I’m not sure this is the case.

Cough and cold medicines are a huge market. Everyone gets colds. No one likes the feeling of a stuffy nose, a runny nose, or a nagging cough. When these symptoms strike children, parents want to do something about it. That’s only natural. According to AC Nielson, about 15% of American households bought cold medicine marketed toward children last year. Total sales reached $311.3 million last year. That’s beyond pocket change, and more importantly represents a 20% increase over the previous year. So it’s a large market, and it’s growing.

Statistics like this have caused leading consumer advocates to question the motives of the pharmaceutical industry. Peter Lurie, of the health research group at Public Citizen, said he believes the voluntary withdrawal was designed to head off a wider ban on marketing the drugs to children under 6 (see video here), which is one of the possible outcomes of FDA hearings scheduled for this week.

"One can only assume that it is fear of additional action that's causing them to take these steps," he said. "It's only the most obvious infant products they are recalling. They probably see the writing on the wall for the younger children and are trying to save the rest of the pediatric market. They are trying to rescue the market for a series of products that do no good, and sometimes cause harm."

This sentiment is echoed by Arthur Levin, director of the nonprofit Center for Medical Consumers and a past member of FDA advisory panels on prescription drug safety.

"At this point, they're worried about their exposure to liability," he said. "There's a level of concern that can't be ignored anymore." The industry, he said, might have calculated that this action would blunt some of the criticism and deflect the FDA from a ban that would extend to children as old as 6.

As a parent, what should you do? Keep in mind that these drugs have never been shown to be any more effective at treating symptoms than drug-free interventions, like drinking plenty of liquids, using a humidifier, and using salt water solutions to treat nasal congestion and sore throats. These methods are safe, and they cost a whole lot less, too!