Doctors question the value of other cold medications after phenylephrine falls: shots

Doctors question the value of other cold medications after phenylephrine falls: shots

Doctors and researchers question the effectiveness of many common over-the-counter treatments for colds and flu.

Jeff Greenberg/Jeffrey Greenberg/Universal Images

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Jeff Greenberg/Jeffrey Greenberg/Universal Images

Doctors and researchers question the effectiveness of many common over-the-counter treatments for colds and flu.

Jeff Greenberg/Jeffrey Greenberg/Universal Images

When you’re strolling down the cold and flu aisle at a drugstore, it’s easy to get lost in the dizzying array of products promising to relieve sinus pressure, dry up colds, and stop pesky coughs. Some concoctions even offer it all in one magic pill.

But doctors say the science behind some of these claims is lackluster.

“There’s not a lot that’s very effective for treating the common cold,” said Dr. Lauren Eggert, a clinical assistant professor in the division of pulmonary allergy and critical care at Stanford University.

“Most of the things out there — antihistamines, decongestants, cough medicines — none of them have a lot of evidence that they’re very effective in improving cough or cold symptoms.”

This message was blasted in the headlines last September when FDA consultants found that oral phenylephrine, the active ingredient in some Sudafed, Mucinex, and Daquil products, was simply ineffective. The review was prompted by inquiries dating back nearly a decade.

Pharmacists say concerns about effectiveness could extend down the aisle. Six medical experts interviewed for this story raised questions about other cold and flu ingredients, including other common cough suppressants and expectorants.

“It is possible that there are products on the market that contain ingredients about which people can ask legitimate questions and which the agency has had difficulty acting on due to the complexity of the regulatory process,” said Dr. Peter Lurie, the agency’s head. Center for Science in the Public Interest, a consumer watchdog group.

Many of the ingredients on store shelves today were outdated more than 50 years ago, when the science supporting many medications did not meet the rigor of current methodologies. This means that companies have been able to create new products using those ingredients without testing their effectiveness.

“In those days, statistics weren’t very sophisticated,” said Dr. Leslie Hindless, PharmD, a professor emeritus at the University of Florida in Gainesville, who was one of the petitioners who pushed for the FDA’s recent review. “The whole concept of the clinical trial and study design was in its infancy.”

But most of these drugs remained on store shelves without question, thanks to the FDA’s arduous drug review process. Reforms included in the CARES Act of 2020 simplify the requirements. Before these reforms, updating or changing a drug’s approval status required FDA notice-and-comment rulemaking, which was slow and cumbersome. Now a much simpler administrative order is required.

The law also gives the FDA the authority to collect user fees from drug manufacturers. The new funds are intended to provide the agency with sufficient staff to carry out new drug reviews and clearance.

For example, pharmacists like Hindelis submitted a citizen petition to the FDA to review oral phenylephrine in 2007. This year’s vote was the first test case for the new law. In the future, it will not take 16 years for medicines to be reviewed.

“The message here is that there are a lot of products on the market that fall into the same category as phenylephrine,” Hendless said. “They’re not intended for diseases where people die or have to go to the emergency room. So they haven’t gotten attention — even from the FDA — yet.”

He believes regulators are likely to find other useless over-the-counter drugs as they review older drugs. “I know for sure that cough suppressants and expectorants are next in line.”

He refers to a set of data he presented in a research paper published in 2018 in the journal Allergy and asthma proceduresIt concluded that claims about many over-the-counter products marketed for respiratory symptoms are exaggerated. The evidence for decongestants, expectorants, and cough suppressants does not “justify their use.”

Eggert agrees. It opened a database called UpToDate, which doctors use as a resource when they want to see a summary of evidence for drugs targeting specific concerns. Conclusions regarding cold and flu treatments are alarming:

  • Antihistamines, vitamins, and herbal remedies are ineffective.
  • Cough syrups, decongestants, expectorants, and zinc may have minimal or uncertain benefits.
  • Nasal sprays and analgesics such as Tylenol and ibuprofen may be effective.

NPR has reached out to the FDA to clarify whether the agency plans to review some of these drugs. The agency did not provide any comment or make anyone available for an interview after numerous requests.

Industry groups like the Consumer Healthcare Products Association are lobbying the agency to keep oral phenylephrine available in pharmacies, even though CVS stores have already begun recalling oral decongestants that contain phenylephrine as the only active ingredient.

In an email, they defended the FDA’s current review process, saying it ensures that cold and flu medications are safe and effective. Additionally, they stated in a statement that “decreasing options and availability of these products will directly impact consumers and the already strained American healthcare system.”

For now, Eggert recommends consumers use products with the best evidence such as acetaminophen (Tylenol) for pain or nasal sprays for clearing the nose.

She doesn’t suggest getting rid of anything else from your medicine cabinet.

“If you’ve used something and felt like it was helpful, I don’t think there’s a problem with that,” Eggert said. “There is little harm to people looking for relief. I believe in the placebo effect.”

But it may be best to avoid mixtures that promise to treat many symptoms at once. Single-ingredient products will help reduce the likelihood of side effects, according to Dr. Shalini Lynch, PharmD, professor of health sciences at the UCSF School of Pharmacy. She says it should be clear within a day or two if the product is relieving your desired symptoms.

She also suggests some natural treatments. A saline nasal rinse may help clear your sinuses, and honey can soothe a cough. In addition, it may be helpful to stand in a steamy bathroom or fill a humidifier to open your nasal passages.

However, Lynch says relaxing on the couch may be your best bet.

“The common cold is something that pretty much needs to run its course,” she said. “You want to feel better right away. But the reality is that most coughs and colds, and viral types of upper respiratory infections, take time to go away.”

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