Rachel Flynn, MPH, Elizabeth Eckel, and Diana Zuckerman, PhD, National Center for Health Research
No one wants to stay home feeling miserable with a cold or the flu. Many adults go to the doctor in search of a cure, or at least some medicine that will keep them, or their children, from missing work or school. However, there is no quick fix for a cold or the flu.
Most colds and respiratory infections are caused by viruses, as is the flu. Unfortunately, a virus must run its course, which usually lasts from 7 to 14 days. Antibiotics only work against bacteria, not viruses. Therefore, they do not work for colds or the flu, and they have clear risks as well.
Most doctors advise that the best way to treat a cold or the flu is by drinking plenty of fluids and getting some rest. But most patients take over-the-counter (OTC) medications. Do they work?
Do Cough and Cold Medications Work?
Cold medications do not “cure” or shorten your cold or flu, but they can ease some symptoms. Some are better than others. For example, Sudafed can be effective for congestion and sneezing, but numerous studies have shown that Sudafed PE is completely ineffective. The reason why Sudafed PE was created despite its clear inferiority to Sudafed was because Sudafed sales slumped when store customers were required to sign for it, since Sudafed’s active ingredient is also used to make an illegal drug, meth.
In general, most over-the-counter cough syrups are not effective for adults or children, according to a study published in the medical journal Chest, and that goes for adults as well. The American College of Chest Physicians (ACCP) emphasize that OTC medicines meant to bring up mucus (expectorants) or cough syrups and cough drops (suppressants) do not treat the underlying causes of a cough. In addition, combination cold medications that treat many different symptoms are rarely a good choice; it makes more sense to choose a medication that only treats the symptoms that are bothering you.
Don’t Give Cough and Cold Medications to Infants or Young Children
Although over-the-counter (OTC) medication for colds and flu are popular, that doesn’t mean they work, especially for children. In January 2008, the Food and Drug Administration (FDA) advised parents that OTC cough and cold medications should not be given to children under the age of two because of the potential risks. Following this announcement, manufacturers of these products changed their warning labels to say they should not be given to children under age four.
Both decisions were the result of criticisms by influential doctors and medical associations, protesting the marketing and widespread use of OTC pediatric cough and cold medications for young children under the age of six. However, when experts had previously been asked by the FDA to provide advice about these medications, the experts had concluded that there was no good evidence that these medications work for children under the age of 12.
The FDA continues to review the research and plans to make an announcement about whether these medications are safe and effective for children ages two through eleven. Meanwhile, the instructions for OTC pediatric cough and cold medications recommend that the products not be used by children under four years of age except under the guidance of a medical professional. However, companies have continued to market these products to parents of infants and young children, with packaging that features images of young children as well as droppers to aid administration of “infant formulations.” As a result, these medications are widely used for infants and young children even though there is no evidence that these products are safe or effective for children under the age of six. They seem to be safe for children ages six to eleven, but may not work.
We agree with the doctors and medical associations that asked that the FDA require studies of the effects and safety of these medications in young children; a public education campaign to inform parents of the lack of evidence for use of OTC cough and cold medications in young children; and labeling to make it clear to consumers that these products have not been found safe or effective in young children.
If the medications don’t work, why sell them? Since many children under 6 are harmed by confusion about the proper use of these medications, and there is no evidence that they work for children that age, the FDA should put large, clear warnings on the label and on any advertisements.
The situation is different for children between six and twelve, because the medications don’t seem to do much harm, but we don’t know if they have any benefit. Most likely, the FDA will ask for better studies to find out if these medications do more good than harm for children under the age of twelve. Meanwhile, the FDA will have to decide if the medications can continue to be sold, and if so, should the labels say that these medications may not work for children under twelve. Some doctors have expressed concern that parents want cold medications for their children, and that many parents will give adult versions of the medications to their children even if the label says not to. That seems to imply that parents are too stupid to follow directions. But, that is not a good reason to allow the continued sale of medications that don’t work.
Antibiotics Don’t Work
Antibiotics are often prescribed for colds or the flu, even though they do not work. According to the Centers for Disease Control and Prevention (CDC), about half of the 100 million antibiotic prescriptions written annually in the U.S. are unnecessary. The American College of Physicians reports that “using antibiotics too much, too often, or not finishing a prescription reduces their effectiveness and can cause a problem called antibiotic resistance.” Antibiotic resistance is when bacteria are exposed to antibiotics and are able to survive by making genes that are resistant to the antibiotic. When harmful bacteria with resistant genes make us sick, antibiotics are no longer an effective treatment.
To cope with the decreasing effectiveness of some antibiotics, new antibiotics have been developed that bacteria are not yet resistant to. However, some of these newer antibiotics, such as Levaquin and Cipro, which are part of a class of antibiotics called fluoroquinolones, can be quite expensive and have substantial risks and side effects compared to older antibiotics such as amoxicillin. Because of those risks, in May 2016, the FDA encouraged physicians and other health care providers to avoid prescription of fluoroquinolones for respiratory tract infections and urinary tract infections unless other antibiotics have been tried and were unsuccessful. In 2018, the FDA strengthened the warnings about their risks of mental health side effects and serious blood sugar disturbances and made these warnings more consistent across the entire class of fluoroquinolones. We also suggest avoiding the Z-Pak when possible, a commonly prescribed antibiotic that can cause potentially fatal side effects, especially for older people and those with heart problems.
The bottom line: antibiotics should not be used for colds, flu, or other viruses. Generally, older antibiotics should be tried first, since they are safer, less expensive, and often just as effective.
The American College of Physicians released guidelines for prescribing antibiotics in conjunction with the CDC, the American Society of Internal Medicine, the American Academy of Family Physicians, and the Infectious Disease Society of America.
These measures are directed at both doctors and consumers in order to lower rates of unnecessary prescriptions for antibiotics. Although it may seem unusual to target patients in addition to physicians, doctors claim that many patients feel entitled to a prescription when they visit the doctor. By educating the public that not receiving medication does not mean substandard care, the American College of Physicians hopes to reduce the pressure on physicians to write unneeded prescriptions.
The American College of Physicians’ Consumer Guidelines for Antibiotics:
Don’t insist on antibiotics for yourself or your children.
Ask your doctor, “Is this antibiotic really necessary?”
Take only with a doctor’s instructions-don’t take antibiotics left over from old prescriptions, given to you by friends or family, or purchased abroad without a prescription.
Prevent infections by washing hands thoroughly. Wash fruits and vegetables thoroughly. Avoid raw eggs and undercooked meats-especially ground meats.
Keep immunizations up-to-date-especially for influenza and pneumonia if you are a senior citizen or have a chronic illness.
Finish each antibiotic prescription-even if you feel better. If you don’t finish the prescription, some resistant bacteria may stay with you and multiply, requiring a different-and most likely stronger-antibiotic when the infection returns weeks later.
The Risks of Medication Can Outweigh the Benefits
The new concerns about OTC medication for children are just the latest warning that popular over-the-counter medications can be dangerous. In 2001, the FDA ordered that all medications containing phenylpropanolamine (PPA) be removed from the shelves because of evidence that taking PPA increases the risk of stroke. FDA’s decision was made after a study at Yale Medical School showed an association between PPA use and stroke in women using the medicine to lose weight. Men may also be at risk.
Although medicines containing PPA should no longer be available at the store, it is possible that you may have medicines containing PPA in your medicine cabinet. To be safe, those medicines should be discarded. They include:
Acutrim Diet Gum Appetite Suppressant Plus Dietary Supplements
Acutrim Maximum Strength Appetite Control
BC Allergy Sinus Cold Powder
BC Sinus Cold Powder
Dexatrim Extended Duration
Dexatrim Vitamin C/Caffeine Free
Dimetapp Cold & Allergy Chewable Tablets
Dimetapp Cold & Cough Liqui-Gels
Dimetapp 4-Hour Liqui-Gels
Dimetapp 4-Hour Tablets
Dimetapp 12-Hour Extentabs Tablets
Tavist-D 12 Hour Relief of Sinus & Nasal Congestion
Triaminic DM Cough Relief
Triaminic Expectorant Chest & Head Congestion
Triaminic Syrup Cold & Allergy
Triaminic Triaminicol Cold & Cough
Some of the medications that used to contain PPA are sold under the same name today, but no longer contain PPA. If you have old versions of any of the following medicines, check to see if they contain PPA. If they do, throw them out.
Alka-Seltzer Plus Children’s Cold Medicine Effervescent
Alka-Seltzer Plus Cold Medicine (cherry or orange flavor)
Alka-Seltzer Plus Cold Medicine Original
Alka-Seltzer Plus Cold & Cough Medicine Effervescent
Alka-Seltzer Plus Cold & Flu Medicine Effervescent
Alka-Seltzer Plus Cold & Sinus Effervescent
Alka-Seltzer Plus Night-Time Cold Medicine Effervescent
Comtrex Deep Chest Cold & Congestion Relief
Comtrex Flu Therapy & Fever Relief Day & Night
Contac 12 Hour Cold Capsules
Contac 12 Hour Cold Caplets
Coricidin ‘D’ Cold, Flu & Sinus
Dexatrim Caffeine Free
Dimetapp DM Cold & Cough Elixir
Naldecon DX Pediatric Drops
The Bottom Line
Medications that are safe for adults may harm children. “Ask your doctor” doesn’t help if there are no good studies for your doctor to read.
For More Information:
The American College of Physicians, “Antibiotics: Do You Really Need Them?”
National Institute of Allergy and Infectious Diseases, “Fact Sheet: the Common Cold”
U.S. Food and Drug Administration, “Colds and Flu: Time Only Sure Cure”
FDA Consumer Update on OTC pediatric cold and cough medications
FDA Public Health Advisory on OTC pediatric cold and cough medications
Citizen’s Petition submitted to FDA in March 2007 concerning safety of OTC cough/cold remedies for children under 6
New York-Presbyterian Hospital
For a full list of products containing PPA
All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.
Meltzer, Eli, Ratner, Paul H., McGraw, Thomas. (Feb 2015). “Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study.” The Journal of Allergy and Clinical Immunology in Practice. 2015 3(5): 702-708; http://dx.doi.org/10.1016/j.jaip.2015.05.007.
Paul Auwaerter, Medscape. “Fluoroquinolones Not First Line: FDA Advisory Reinforces Standard Practice in Ambulatory Care.” June 2, 2016. http://www.medscape.com/viewarticle/863778?nlid=105951_1521&src=WNL_mdplsfeat_160607_mscpedit_wir&uac=140425SY&spon=17&impID=1120485&faf=1
U.S. Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. July 2018. Retrieved her