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Reviews for over-the-counter drugs are long overdue, experts say


In September, advisers to the Food and Drug Administration determined that a popular decongestant in cold and flu medications does not work. But the FDA hasn't updated the official list of approved over-the-counter drugs in decades, and some medical experts say additional reviews are long overdue. Lesley McClurg from member station KQED explains.

LESLEY MCCLURG, BYLINE: Everyone knows that feeling. Your head's pounding. You can't breathe. You're sneezing. So you go to the drugstore.


UNIDENTIFIED PERSON #1: I'm picking remedies from the cold and flu aisle.

UNIDENTIFIED PERSON #2: Proven to shorten colds.

MCCLURG: Proven might be a stretch, given the news that flooded headlines in September.


UNIDENTIFIED JOURNALIST: A key ingredient in the over-the-counter cold medicines that so many of us buy, well, it just doesn't work.

MCCLURG: A unanimous advisory panel to the FDA determined oral phenylephrine, which is found in some Mucinex, DayQuil and Theraflu products, is no better than a placebo. Half a dozen medical experts interviewed for this story raised questions about other cold and flu drugs as well. Dr. Peter Lurie is the president of the Center for Science in the Public Interest, a consumer watchdog group.

PETER LURIE: There could well be products that are on the market containing ingredients about which people could legitimately have questions and which the agency has had a difficult time acting on because of the elaborateness of the regulatory process.

MCCLURG: The FDA has been hamstrung for decades by an arcane notice and comment process. Many of the ingredients on store shelves today were grandfathered in more than 50 years ago, when the science backing many drugs did not meet the rigor of today's methodologies. Then, in 2020, a new law passed that is designed to make it easier to remove ineffective drugs from the market.

LURIE: This really gives the agency an opportunity to do what I think it always wanted to do, which was to take a look at at least the most problematic of the drugs currently available.

MCCLURG: The recent review and vote on oral phenylephrine is the new law's first test case, but doctors like Lauren Eggert hope it will be the first of many. She's a pulmonologist at Stanford University.

LAUREN EGGERT: Most of the things out there - antihistamines, cough medicines - none of them have a lot of evidence that they're super effective at improving common cold symptoms.

MCCLURG: When she wants to vet a cold medication, she uses an online database for doctors called UpToDate, which draws on the latest science.

EGGERT: And I'm pulling it up now, and it says therapies with minimal or uncertain benefits - dextromethorphan, which is in cough syrup, decongestants, expectorants...

MCCLURG: Those are medications that promise to clear mucus.

EGGERT: ...Zinc and herbal products.

MCCLURG: All of those are shown to have minimal or uncertain benefits. NPR reached out to the FDA to clarify whether the agency is planning to review some of these drugs. They did not provide comment or make anyone available for an interview after numerous requests. For now, Dr. Eggert recommends taking products with the best evidence, like acetaminophen for pain or nasal sprays to clear the nose. So should you toss out the rest? Not necessarily.

EGGERT: You know, there's little harm, and people are looking for relief. And I do believe in the placebo effect.

MCCLURG: The Consumer Health Care Product Association represents companies that make cold and flu medications. In an email, they defended the FDA's review process, saying it ensures that over-the-counter drugs are safe and effective. But at the end of the day, doctors say drugs may not be the key to getting better.

SHALINI LYNCH: You know, the common cold is something that pretty much needs to run its course.

MCCLURG: That's Dr. Shalini Lynch. She's a pharmacist at University of California, San Francisco.

LYNCH: You want to feel better instantly. But the reality is most viral types of upper respiratory infections, they just take time to go away.

MCCLURG: She says cozying up on the couch is probably your best bet. For NPR News, I'm Lesley McClurg in San Francisco. Transcript provided by NPR, Copyright NPR.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

Lesley McClurg