The FDA Now Warns Against Buying Certain OTC Meds for the Flu

The agency is issuing a new alert for consumers as cases surge.

We're in the heart of flu season right now, and many people are reasonably on edge. The U.S. Centers for Disease Control and Prevention (CDC) estimates that there have been at least 18 million illnesses, 190,000 hospitalizations, and 12,000 deaths from the influenza virus so far this season.

Many people run to the drugstore for relief at the first sign of a sore throat or runny nose, but you might want to think twice before ringing up your purchases, as the U.S. Food and Drug Administration (FDA) has just issued a new alert about certain over-the-counter (OTC) flu meds. Read on to find out which drugs the agency is warning consumers about.

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The supply of cold and flu medications has been volatile.

Empty shelves in a pharmacy due to supply shortages of cold, cough, and flu medication and increased demand due to seasonal illnesses

Many people in the U.S. have struggled to find cold and flu medicines recently. Local news reports and social media posts have been showing empty shelves at pharmacies across the country for weeks now. Joe Lutmer, the owner and pharmacist at Tischbein Pharmacy, told NBC-affiliate WLWT in December that due to the cold season starting much earlier than usual, and with more vengeance following the pandemic, he has been struggling to keep both prescribed antibiotics and OTC meds in stock.

"Every single day, it's a new problem. Every single day, we have to contact all our different wholesalers and find out what the availability of these products are," Lutmer said. "Our shelves at certain times have been completely empty of one product and then comes back on, and then it's empty of another product."

Major retailers like Walgreens and CVS have also found similar trouble, prompting them to put purchase limits on certain cold and flu meds. "Retailers nationwide are experiencing supplier fulfillment challenges due to increased demand of over-the-counter pediatric fever reducing products," Walgreens spokesperson Fraser Engerman told CNN. But now the FDA is warning consumers not to let the recent difficulty in securing these medications push them into a concerning path.

The FDA has issued a new alert about certain OTC meds for the flu.


With supply issues running rampant, you might be tempted to buy whatever cold and flu medication you can get your hands on. But in a new consumer update posted Dec. 13, the FDA raised concern over certain flu meds. "There are no legally marketed over-the-counter (OTC, or non-prescription) drugs to prevent, treat, or cure the flu," the agency explained. "But there are legally marketed OTC drugs to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu."

This won't stop con-artists from trying to "illegally offer unproven products that claim to prevent, mitigate, treat, or cure the flu," the FDA warned in its new alert. "The fall and winter flu season may bring out dishonest sellers hawking fraudulent products to unsuspecting consumers," the agency said.

Fraudulent flu products are sold without a prescription and may be marketed with a number of false claims. This could include claims to "reduce the severity and length of the flu or other viral infections; boost your immunity naturally without a flu vaccine; act as a safe and effective alternative to the flu vaccine; prevent you catching the flu or viral infections; be an effective treatment for the flu or viral infections; provide faster recover from the flu or viral infections; or support your body's natural immune defenses to fight off the flu," according to the FDA.

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The agency is warning consumers not to buy these products.

Sick ill man looking for medicines at pharmacy shelf

The FDA is asking people to protect themselves against these illegal OTC meds, which could be found online and in retail stores. "These products might be dangerous to you and your family," the agency said. "The FDA urges consumers to avoid fraudulent flu products." But what exactly is the danger? Kelly Johnson-Arbor, MD, a medical toxicology physician and director at the National Capital Poison Center, tells Best Life it all boils down to the fact that they haven't been evaluated by the FDA for safety or effectiveness.

"Although there are prescription drugs available to prevent or treat the flu, there are no OTC medications that are FDA-approved for this purpose," Johnson-Arbor said. "OTC anti-flu products meant to be taken by mouth (like dietary supplements or unapproved medications) may contain undisclosed ingredients that can be potentially harmful or can interact with other prescription medications. These products may contain prescription medications, pesticides, or heavy metals that can cause unwanted side effects."

Officials say the flu vaccine is your best prevention measure.

vaccine in researcher hands, female doctor holds syringe and bottle with vaccine for coronavirus cure. Concept of corona virus treatment, injection, shot and clinical trial during pandemic.

The flu is nothing to mess with, which is why officials push prevention as the first line of defense. "Getting a flu vaccine is the best way to prevent this infectious disease and its serious complications," the FDA said—and the CDC recommends that everyone six months and older get vaccinated against the influenza virus every year.

Vaccination is not 100 percent effective, so some people may still get sick even after getting their flu shot. But the CDC says vaccination can still "reduce severity of illness in people who get vaccinated but still get sick."

If you do come down with the flu, several FDA-approved drugs can be prescribed to treat it. "Flu antiviral medications are used to prevent or treat flu and are available by prescription in the form of pills, liquids, inhalers, and intravenous infusion," the agency explained. "The various products are all approved for adolescent and adult use, and they differ in the ages for which they are approved to treat infants and children, ranging from 2-weeks-old to age 12."

Exercise caution when taking OTC medications.

Standing in the store pharmacy, the unrecognizable woman holds over the counter medicine as she tries to make a decision.

If you decide to go the OTC med route, Johnson-Arbor advises looking for legally marketed medications. "Since there are no OTC drugs proven to cure the flu, people should choose OTC products that can instead help reduce the signs and symptoms of the flu," she says.

According to the medical toxicologist, Tylenol (or other acetaminophen meds) can help with treating fever and body aches, while decongestants like Sudafed (or other pseudoephedrine meds) can help get rid of nasal congestion. But while these medications are FDA-approved, you still need to exercise caution. "Because many OTC products contain multiple ingredients, it's important to read package labels carefully to ensure that you are not taking unnecessary medications or duplicates," Johnson-Arbor adds.

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