Phenylephrine-containing OTC oral decongestants on the FDA chopping block; No mention of Rx versions
On November 7, 2024, the FDA announced its proposal to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) medications. This includes pills, liquids, powders that are mixed with liquids, and capsules. If the proposal is approved, multi-ingredient cold medications like Nyquil, Theraflu, Sudafed PE, Advil Sinus, and Alka-Seltzer Plus will no longer be allowed to use the ingredient. The proposal follows a September 2023 unanimous determination by the FDA's Nonprescription Drug Advisory Committee that oral phenylephrine hydrochloride, which has been used as a decongestant for 30 years, does not work any better than placebo.
The FDA final decision will be delayed for at least six months, until after the public comment period ends in May 2025. (Perhaps this FDA delay is by design, as a delay will also give manufacturers a chance to change their production formulas.)
FDA Announcement on phenylephrine (November 7, 2024)
The public can comment on the proposal, and FDA will review the public comments before finalizing a decision.
Risk of elevated blood pressure
Because phenylephrine can raise blood pressure (in fact, it's used for that purpose in some formulations), people trying to avoid that risk should make sure to read the ingredients listed on the product package (the Drug Facts label) to avoid buying OTC oral meds with phenylephrine. Phenylephrine-containing products are still on the shelves, especially in the multi-ingredient cold and allergy category.
An FDA information guide discusses oral phenylephrine and over-the-counter medications, how to check a drug label, and how to find alternative products for nasal congestion for colds and allergies.
Many phenylephrine meds are not affected by the proposal
The drug ingredient phenylephrine hydrochloride is not going away; it will still be found in over-the-counter nasal decongestant sprays and a variety of other treatment types. Here are some examples of phenylephrine-containing drugs that might come as a surprise to some consumers:
1. It is used in over-the-counter eye drops to treat irritation and redness.
2. It is used in over-the-counter hemorrhoid topical creams and suppositories, such as Preparation H.
3. As a prescription drug, ophthalmic solutions are used by medical practitioners in to dilate a patient's eyes.
4. As a prescription drug, it is administered by injection (I.V.) by medical practitioners to treat hypotension (low pressure, often caused by anesthesia or septic shock.)
Should phenylephrine be removed from prescription-only oral decongestants too?
In its press announcement, the FDA doesn't mention whether it is also considering removing oral phenylephrine from prescription-only drug products.
Read our September 2023 article about placebo decongestant outrage:
Looking for the November Drug Safety Update? Part 2 will be sent later today. Check out Part 1 here:
