A duo of articles at the NYT looks at institutional efforts and mothers' concerns about the proposed FDA ban.
Pediatric cold medicines were approved in the early 1970s despite almost no evidence that they worked because regulators assumed then that drugs that worked in adults would also be helpful in children. Since then, researchers have learned that adults and children can react to medicines very differently.Effectiveness has to be considered in the context of a claim of efficacy. Decongestants decongest. Acetaminophen reduces fever and pain. Antihistamine... well, they make people sleepy and that's probably the main reason they are so popular. A little rest, a little relief, a good night's sleep...
What cold medicines don't do is fix the cold. They do not reduce the duration. They do not reduce the risk of complications (like ear infections). They do not reduce the overall severity of the cold.
The best advice with a cold medicine is not to take it regularly. It is not an antibiotic and the expectation needs to be tempered with a dose of realism. Do not date the medication exactly every four hours or six hours or twelve hours. Your doctor probably said "as needed," that means go ahead when you are really miserable and desperate for relief. It does not mean, "just in case it gets worse overnight." Just ask, OK?
So being peevish about efficacy revolves around what you're trying to accomplish with the medication. The FDA is right in saying cold medicines are ineffective in reducing the duration or severity of the condition. But cold medicines are effective at reducing symptoms, which was the original intent of cold medicines, naturally taken advantage of and stretched by manufacturers.
People should treat all medications with the utmost respect and only take them when absolutely necessary. One mother quoted by the NYT kind of had it right...
“Oh, I’ll probably ignore [the ban],” Ms. Frank said, speaking over the cacophony of a four-children-in-a-brownstone play date that sounded more like New Year’s Eve on Times Square. “It’s miserable if they can’t sleep. So I’m afraid I’d use it, regardless. But sparingly. And if they were babies, I’d hesitate.”The demand to help parents whose kids are sick is not going away. Maybe education and limits on inappropriate marketing by manufacturers would work better.
But the problem is that the FDA appears to be looking for the best arguments to put forward in anticipation of the amount of resistance they will face. When they stoop to an irrelevant misrepresentation about the lack of efficacy (symptom versus condition), it probably means they are facing a really big fight. Maybe there are bigger fish to fry for the FDA? Why use the weighty force of government rather than an education campaign?