Benadryl Remains Available Over-The-Counter Despite FDA Panel’s Vote

The popular antihistamine Benadryl is not being removed from pharmacies in the U.S., despite some misleading headlines suggesting otherwise. The over-the-counter medication, which contains diphenhydramine as its active ingredient, is still considered safe and effective for treating allergies, colds, and other conditions.

FDA Panel Votes Against Phenylephrine

The confusion arose after a Food and Drug Administration (FDA) advisory committee voted 16-0 on Tuesday that current scientific data does not support the use of the active ingredient phenylephrine in over-the-counter products such as Benadryl Allergy Plus Congestion. Phenylephrine is a nasal decongestant that is supposed to relieve congestion by shrinking the blood vessels in the nose. However, the panel concluded that products that include phenylephrine are not effective against nasal congestion, though they were not deemed unsafe.

The FDA panel’s vote does not affect antihistamines such as Benadryl that contain diphenhydramine, which is a different type of drug that works by blocking the effects of histamine, a chemical that causes allergic reactions. Diphenhydramine is also used as a sleep aid and a cough suppressant. The FDA panel did not question the efficacy or safety of diphenhydramine in over-the-counter products.

What Does This Mean For Consumers?

If the FDA follows the recommendation of the panel and removes oral phenylephrine from its approved list of over-the-counter ingredients, products containing it would no longer be able to be sold in the U.S. without a prescription. This would affect some of the most common cold and allergy medications, such as Sudafed PE, DayQuil and NyQuil Severe Cold and Flu, Mucinex Cold and Flu, Tylenol Cold and Flu, Tylenol Sinus and Headache, Robitussin Cough and Allergy, Advil Cold and Flu, and Benadryl Allergy Plus Congestion.

Benadryl Remains Available Over-The-Counter Despite FDA Panel’s Vote

Drug manufacturers may need to reformulate their products to replace phenylephrine with another decongestant, such as pseudoephedrine, which is also effective but has some restrictions due to its potential misuse for making methamphetamine. Pseudoephedrine-based products, such as Sudafed, are sold behind the pharmacy counter and require consumers to show identification and sign a log. Alternatively, consumers may opt for nasal spray decongestants, such as Afrin, which contain phenylephrine or oxymetazoline and are still thought to be effective.

Benadryl Is Not Without Controversy

Despite the antihistamine Benadryl not being impacted by the FDA panel’s vote, this is not to say that Benadryl is without controversy. Outside the U.S., in many jurisdictions, including Germany, the Netherlands, and Sweden, Benadryl is only available with a prescription. This is because as a first-generation antihistamine, diphenhydramine crosses the blood-brain barrier, which causes sedation in patients. Moreover, the FDA has issued warnings that taking higher than recommended doses of Benadryl can lead to serious heart problems, seizures, coma, or even death.

The newer generation, less-sedative over-the-counter antihistamines, such as Claritin (loratadine) and Zyrtec (cetirizine), are generally considered safer than first-generation ones. However, some consumers may prefer Benadryl for its faster onset of action and stronger antihistamine effect. Benadryl is also widely used for treating insect bites, rashes, hives, and other skin conditions.

How To Use Benadryl Safely

Benadryl is a safe and effective medication when used as directed by the label or by a doctor. Consumers should follow these tips to use Benadryl safely:

  • Read the label carefully and follow the dosage instructions. Do not take more than the recommended dose or more often than directed.
  • Check the ingredients of other medications you are taking to avoid taking too much diphenhydramine or other drugs that may interact with it. Some products may contain diphenhydramine under different names, such as Nytol, Sominex, or Unisom.
  • Be aware of the side effects of diphenhydramine, such as drowsiness, dizziness, dry mouth, blurred vision, and constipation. Do not drive or operate machinery after taking Benadryl. Avoid alcohol and other sedatives while taking Benadryl.
  • Consult your doctor before taking Benadryl if you have any medical conditions, such as asthma, glaucoma, heart disease, high blood pressure, thyroid problems, or prostate problems. Benadryl may worsen these conditions or interfere with your medications.
  • Consult your doctor before giving Benadryl to children under 6 years old or to pregnant or breastfeeding women. Benadryl may have different effects on these groups or may not be suitable for them.

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