The cold, flu, and allergy season may be a little bumpy.

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Phenylephrine, a popular ingredient in many allergy and cold over-the-counter medications, was recently found not to work in tablet form.

The FDA held a Non-prescription Drug Advisory Committee on Tuesday, September 11-12, 2023.   During the meeting, data presented showed that phenylephrine in a tablet form is ineffective for the consumer.

The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.

What does this mean for the consumer?

As of right now, the FDA has the data from the committee.  They will consider that information before taking action on the ingredients in many OTC medications.

What does this mean for my OTC medications?

If the FDC decides that phenylephrine isn't making a difference to the consumer,  it will pull the usage of the drug.  The OTC medications in tablet form that contain phenylephrine will be removed from store shelves.

If FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from this monograph [GRASE, generally regarded as safe and effective].

If this does occur, companies that produce these medications will either have to pull the drugs from store shelves or reformulate the product.  Either of these choices will cost the companies a lot of money.

 FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.

As of this time, the FDA has not decided on phenylephrine.

These are some of the OTC medications that risk being pulled from the shelves or reformulated.

  • Advil Sinus Congestion & Pain
  • DayQuil and NyQuil Cold & Flu
  • Flonase Headache & Allergy Relief
  • Benadryl Allergy Plus Congestion for Sinus Pressure & Nasal Congestion Relief
  • Robitussin Nighttime Severe Multi-Symptom Cough, Cold + Flu Syrup
  • Sudafed PE Sinus Congestion
  • Theraflu Daytime Severe Cold Relief Berry Burst Flavor Hot Liquid Powder
  • Tylenol Sinus + Headache Non-Drowsy Daytime Caplets for Nasal Congestion, Sinus Pressure & Pain Relief
  • Mucinex Sinus-Max Severe Congestion Relief Caplets
  • Mucinex Max Strength Cold & Flu Medicine
  • Mucinex Maximum Strength Sinus-Max Severe Congestion & Pain & Nightshift Sinus Liquid
  • Alka-Seltzer Plus Severe Cold and Flu
  • Store or Generic versions that contain phenylephrine

Now we wait and hope the FDA makes their decision soon, otherwise, there may be some grumpier sick people walking around this cold, flu, and allergy season.

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