On September 11th, an advisory panel to the FDA ruled that an active ingredient in many common over-the-counter cough and cold products is not effective. Phenylephrine, the drug in question, was found to reach the nose less than 1% of the time it was administered orally.
Here is a short guide to all the questions and concerns you may have about finding effective and safe medicine this fall and winter.
What is Phenylephrine?
Phenylephrine is a drug that is included in many medicines to reduce nasal congestion and pressure. It can be administered several ways, but the most common method is orally, through pills like Sudafed and Mucinex. Oral doses of phenylephrine were found to be ineffective, nasal sprays are not included in this ruling.
Why is it no longer effective?
Nothing about the drug’s formulation or chemical makeup has changed. Phenylephrine gained popularity in 2006 after another decongestant, pseudoephedrine, was restricted by the FDA because of its use in the manufacture of methamphetamine.
In 2007, orally administered phenylephrine was challenged, but it remained on the market. Post-pandemic, interest in the decongestant was renewed as agency staff was increased and FDA procedures were overhauled.
Is Phenylephrine dangerous?
No. While it may not be effective, it is important to note that the FDA did not raise any concerns about safety issues with the use of oral phenylephrine at the recommended dose. It is a placebo, and any medicine with it as an active ingredient should be treated as such.
You may see information online about the FDA considering removing phenylephrine’s classification as generally recognized as safe and effective (GRASE). This is only because it is not effective, not because it is unsafe.
What Medicines have Phenylephrine in them?
The most common over-the-counter medicines that have phenylephrine in them are:
You should note that some products with phenylephrine in them have other active ingredients, such as ibuprofen or acetaminophen. These active ingredients are still effective in treating symptoms other than congestion, such as headaches or muscle aches, and should not be disregarded by association simply because of the FDA’s new ruling.
If you have an oral medication with phenylephrine listed as an active ingredient, remember that it will not be effective in treating nasal congestion.
What can I buy if I need over-the-counter decongestants?
Alternative treatments include nasal decongestants, intranasal steroids, antihistamines, and saline products. Pseudoephedrine, mentioned previously in a paragraph above, is sold on the retail market and is included in oral medication but is only available behind the counter.
What to do next?
Keep checking back at PatientsLikeMe.com for updates on the FDA ruling and guidance about treatments, solutions for your complex conditions, tools to make managing your life easier, and support from people who know what you are going through!