Cold Remedies and the FDA: Is your medication really safe?

Sloane Miller Health Guide
  • Did you see this latest report that's been making it's way around the mainstream media channels? "A Food and Drug Administration panel of experts voted overwhelmingly today that there was no evidence that popular pediatric over-the-counter cough and cold medicines have any effect."


    Sigh, really?


    How may of us were spooned back into health with over-the-counter remedies as children in the 1970s and 1980s? Robitussin was on my cold menu, along with Sudafed, and Vick's vaporub.


    What about you? What was your family's go-to over-the-counter cold drug of choice? Did it work? Or did you feel nothing at all?

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    According to this panel, these over-the-counter cold remedies are no better than placebos for children under 6 years old. Additionally, when they approved these drugs for use in children in the 1970s, there were few studies to test efficacy, according to news reports. "Pediatric cough and cold medicines were approved in the early 1970s despite almost no evidence that they worked because regulators generally assumed that drugs that worked in adults would also be helpful in children. Since then, dozens of drugs first tested only in adults have been found to be entirely ineffective or improperly dosed for children."


    Now that's upsetting. Makes me wonder what else the FDA didn't test, then and now. I know a lot of you are wondering about the new HFA inhaler and wondering what the FDA is thinking in making this drastic seeming change for asthma rescue inhalers. This latest blow to confidence in the FDA is troubling, to say the least.


    The article in the New York Times continues to state that: "Even in adults, the evidence is 'modest at best' that the drugs actually work, said Dr. Mary E. Tinetti, the chairwoman of the panel who is a professor at Yale University School of Medicine." Now this surprises me too, but less.


    A few years back when I had a cough building and I was hoping it wouldn't turn bronchitis-y [my Achilles heel] I asked my doc, who's also a pulmonologist, if there was anything I could take for the hacking. He suggested Mucinex, an adult cousin of Robitussin, which uses the same active ingredient, Guaifenesin. When I asked him how well Mucinex worked, he shrugged his shoulders and said, "It may help, it may not".


    I didn't take it; I don't like taking meds if I don't have to, and he wasn't encouraging that it would work. Why would a medicine be on the market if it didn't really work?


    According to the article, "many drugs Americans commonly use have never been examined closely and may not work. Standards for clinical trials have changed dramatically over the last 30 years, but thousands of drugs presently sold were approved under older, less stringent standards." This throws a very different light on the over the counter medications we've all been taking for 30 years for aches, fever, pain, cough. It also throws into question, again (see the recent mess on vioxx), about how our current system for approving medications is working or not working.


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    Do you trust your over-the-counter medications to work? Do you trust prescriptions?

Published On: November 05, 2007