Pandemics: Past, present, and future
Which Cold Remedies Actually Work — If Any? Experts Weigh In
Wander down the cold-medicine aisle in any drugstore and you'll find an eye-watering variety of pills, capsules, nasal sprays and potions.
Do any of them really work? That's a legitimate question following the September announcement from the Food and Drug Administration that phenylephrine — an ingredient in dozens of cold and allergy meds — is worthless as a decongestant.
In the wake of that news, major pharmacy chains like CVS began pulling products made with phenylephrine off their shelves. So, if you get a cold, are there any alternatives?
Not many, say most doctors.
"There's just not much that's very effective for treating the common cold," Dr. Lauren Eggert, clinical assistant professor at Stanford University, told NPR.
"Most of the things out there — antihistamines, decongestants, cough medicines — none of them have a lot of evidence that they're super effective at improving cough or common cold symptoms," Eggert added.
Which cold medication works best? None of them, say most experts. Jeffrey Greenberg/Universal Images Group via Getty Images FDA foot-draggingThe problem started decades ago, when the standards for getting US Food and Drug Administration approval were much lower, and clinical studies were a relatively new phenomenon. Many drugs were approved for use despite scant evidence of their effectiveness.
Now, if drugs that have been on the market for decades fall under scrutiny by the FDA — a lengthy bureaucratic process that can take years — they may fall short of expectations, as phenylephrine did.
Until then, however, they're "grandfathered in" and are available to consumers even though they don't provide much relief, if any.
A 2018 report in the journal Allergy & Asthma Proceedings revealed that there's virtually no relationship "between marketing claims and evidence regarding OTC [over-the-counter] medications used for respiratory symptoms" of the common cold.
Report authors also found that "neither OTC mucolytics [mucus-thinning drugs like Mucinex] or antitussives [cough suppressants like Robitussin] provided sufficient evidence to justify their use."
Eggert cites evidence showing that antihistamines, vitamins and herbal remedies are mostly ineffective, while cough syrups, decongestants, expectorants and zinc have minimal or uncertain benefits.
Fortunately, there are some proven ways to help ease cold symptoms. Serhiy Hipskyy – stock.Adobe.Com Which cold meds work?If you're suffering from the symptoms of the common cold — sneezing, coughing, sore throat, stuffy or runny nose — take heart: There are some things that can help.
For aches and pain, use proven remedies like acetaminophen (Tylenol) or ibuprofen (Advil). Note that if you're running a high fever, you might have something more serious like the flu, which these painkillers can also relieve.
Saline nasal sprays and drops are recommended to ease stuffiness and congestion, according to the Mayo Clinic. Taking a hot shower, or using a humidifier to add moisture to the air, can also help you breathe easier.
Honey added to hot tea can soothe your throat and ease coughing — but because you need to get some extra rest, add honey to decaffeinated or herbal tea that won't keep you awake.
The Mayo Clinic also suggests a saltwater gargle — 1/2 teaspoon of salt dissolved in an 8-ounce glass of warm water — to temporarily relieve a sore or scratchy throat.
But experts recommend caution before trying these remedies on young children, who might not be able to gargle properly, keep a cough lozenge in their mouths or may have a bad reaction to pain medications or dosages intended for adults.
She looks like she could use some chicken soup. Pormezz – stock.Adobe.Com Grandma was right about chicken soupA bowl of hot chicken soup can help alleviate some of the symptoms that come along with having a cold, said Kara Collier, a registered dietitian nutritionist and co-founder of Nutrisense in Chicago.
"The veggies and seasonings, like garlic and herbs, that go into chicken soup can also provide important minerals, anti-oxidants and amino acids that help support our body's immune system," she told Fox News Digital.
"The warm broth itself may also help to open up congested nasal and throat passages, which helps to better manage cold and flu symptoms," Collier added.
But the best remedy might simply be taking a day or so to rest up. "The common cold is something that pretty much needs to run its course," Dr. Shalini Lynch, clinical professor at University of California – San Francisco's School of Pharmacy, told NPR.
"You want to feel better instantly. But the reality is most cough and cold, viral types of upper respiratory infections, just take time to go away," Lynch said.
Why DID It Take FDA So Long To Tell Us Our Cold Meds Don't Work? House Republicans Summon FDA To Explain Why Decision On Over-the-counter Decongestant Took 50 YEARS
Republicans will make Food and Drug Administration officials explain why it took so long to deem a common stuffy nose medicine ineffective despite years of evidence.
Michigan Republican Representative Lisa McClain has spearheaded the effort, giving regulators until December 11 to schedule a visit to the Capitol Hill for an official meeting with House members.
The FDA announced in September that phenylephrine, long used as a decongestant in popular oral medicines such as Sudafed PE Sinus Congestion and Vicks Nyquil Severe Cold and Flu, was no more effective than a placebo at alleviating a stuffy nose.
Drugs that contain it generated almost $1.8 billion in sales last year, yet evidence pointing to its ineffectiveness as a decongestant goes back about 50 years.
Rep Lisa McClain [pictured] is a Republican from Michigan. She has compelled FDA regulators to visit Capitol Hill to explain why it took so long to find that oral forms of phenylephrine, a common ingredient in decongestants, was as effective as a placebo pill
An FDA panel voted in September unanimously that phenylephrine was ineffective. The vote does not mean that manufacturers must pull products from shelves, though some stores may follow CVS' suit and stop selling them
The FDA's Non-Prescription Drug Advisory Committee (NPDAC) voted unanimously in September to deem the ingredient ineffective in oral form. It is extremely common in brands like Sudafed, Tylenon, Benadryl, Alka-Seltzer, Mucinex, and Vicks Nyquil and Dayquil.
Medicines containing phenylephrineThe ingredient is protected under the FDA's Generally Recognized as Safe and Effective (GRASE) designation.
The vote did not mean that manufacturers would have to pull products containing the ingredient from shelves, though CVS did so soon after the two-day meeting ended.
But other major chains such as Walgreens and RiteAid have told DailyMail.Com that they will only pull products from shelves if the FDA demands them to do so.
An order for top medicine manufacturers such as Vicks, Tylenol, and Robitussin to halt sales or reformulate could issue a major financial blow to the massive cold medicine industry, though it's not clear if this factored into the FDA's decision to keep the ingredient widely available for decades.
Rep McClain, chairwoman of the House Oversight Subcommittee on Health Care and Financial Services compelled FDA officials to arrange a meeting by next week. It is not clear yet whether the meeting will be public.
She said: 'What is the point of having an FDA if they can't do their jobs? Americans deserve better, and @GOPoversight is holding the FDA accountable for this colossal failure.'
Phenylephrine hit the market in the 1930s and has been used in more than 260 over-the-counter cold medicines since the 1970s.
The medication was meant to constrict blood vessels to clear congestion.
The medicine is metabolized in the gut, allowing just a fraction to enter the bloodstream, which is how it reaches the nose.
In fact, briefing documents compiled by the FDA show that less than a one percent concentration of the drug is able to reach the nose after being broken down in the gut.
The documents detailed flaws in the trials for the ingredient in the 1960s and 1970s, citing small sample sizes and relied on techniques no longer used by the FDA to approve medications.
Dr Leslie Hendeles, an expert at the University of Florida in pharmacokinetics, or the way medicines move throughout the body, was the first to critique phenylephrine in 1993 in a study that compared the efficacy of that and other more cold remedies including pseudoephedrine, the main ingredient of Sudafed.
He found that phenylephrine in pill form is rapidly absorbed in the gut and eliminated before it can have any effect, rendering it essentially worthless.
At the same time At the time, UF professor Dr Randy Hatton was running a pharmacy research lab at UF where students would field questions from medical professionals about certain drugs and work to find the answers.
They were suddenly receiving an influx of calls from pharmacists saying customers have complained about their cold medicines not working.
This prompted Drs Hatton and Hendeles to compile every study they could find on phenylephrine, evaluate them all, and in 2007 conclude that the standard 10-milligram dose was no more effective than a sugar pill.
Rep McClain said in her letter to the FDA: 'Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs.
'It is important that the American people have confidence in the FDA's approvals and trust that the drugs they purchase are not only safe, but also effective.'
Phenylephrine differs from the ingredient found in Sudafed, which is called pseudoephedrine and has typically been considered more effective.
But it's also a highly sought-after chemical precursor in clandestine labs manufacturing methamphetamine, a fact that until Breaking Bad character Jesse Pinkman showed up in Americans' living rooms, many may not have known.
Because of this, Sudafed purchases are limited to just one box per customer and must be procured from behind the pharmacy counter.
Cough Medicine: Should You Or Shouldn't You?
Coughs send more people to the doctor's office than any other specific symptom. And Americans spend billions of dollars every year on over-the-counter medications like suppressants and expectorants to treat them.
Clearly we're concerned about our coughs. Clearly lots of us rely on medications to treat them. What's unclear is the answer to this core question: Do these medicines work?
"We've never had good evidence that cough suppressants and expectorants help with cough," says Norman Edelman, MD, senior scientific advisor at the American Lung Association. "But people are desperate to get some relief. They're so convinced that they should work that they buy them anyway."
Should you use these products? Here's what you need to know about the pros and cons of common cough medicines.
Coughs cause a lot of misery.
Many of us badly want an effective cough treatment, but we don't seem to have one. No new licensed remedy has appeared in more than 50 years -- and the case for older drugs isn't strong.
It's important to understand that these studies don't say cough medicines don't work. Rather, they've just found no proof that they do. It's always possible that further studies could show that they help.
Because of a lack of good evidence that cold and cough medicines help -- and a very small risk of serious side effects -- the FDA said in 2008 that toddlers and babies shouldn't get these products. Drug makers agreed to change the labeling of over-the-counter cough and cold remedies. Now they're only recommended for children ages 4 and older.
The American Academy of Pediatrics went further, saying there's no reason parents should use them in children under 6.
But moms and dads might not be listening. In a nationwide poll, more than 60% of parents with children under age 2 said they've given their kids cold or cough medicine.
People find them reassuring, says John E. Heffner, MD, past president of the American Thoracic Society.
When we're sick with a cough -- or worse, when our children are sick -- we'll do anything to relieve it. Knowing there's a medicine we can use makes us feel more in control. People may also start feeling better a few days after taking a cough medicine, so they assume it's working. But the cough just goes away on its own, Edelman says. The medicine has little to do with it.
Although experts agree that young children shouldn't take cough medicine, they're OK for most older children and adults. The odds of serious side effects are very small, Edelman says.
That said, anyone with a medical condition -- like heart disease or high blood pressure -- should check with a doctor before using any cold medicine.
Heffner says you should also see your doctor if a cough lasts longer than 5 to 7 days, or comes with other symptoms like a fever or rash.
Don't overuse the drugs in cough and cold medicines. This can happen accidentally. You could take more than one brand of cold and cough medicine without realizing that both contain the same ingredients. Or you might take multiple doses because the first didn't help. If one dose doesn't help, more won't get the job done either, Edelman says. Instead, you'll put yourself at risk of an overdose.
Experts say it may not help a lot, but it probably won't hurt older children and adults.
Your doctor might even suggest it. "I consider a cough suppressant in some patients who have a chronic cough that hasn't responded to other treatments," Heffner says.
If you're wary of using over-the-counter cough treatments, try a little honey in warm tea. It's just for adults and older kids, though. Honey isn't safe for children under age 1.
There's one last thing to consider before reaching for the medicine. Coughing can be good for you. It's how our bodies clear out excess mucus and other irritants, Edelman says.
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