CVS Health made a recent announcement on Oct. 19 regarding the removal of certain oral cough and cold products from store shelves. This decision was prompted by an announcement made by advisers to the Food and Drug Administration (FDA) on Sept. 12, stating that the active ingredient, phenylephrine, found in popular over-the-counter decongestants like Sudafed PE, Vicks DayQuil, and Theraflu, is ineffective. A panel of 16 experts unanimously concluded after a two-day meeting that phenylephrine works no better than a placebo pill.
It’s worth noting that the FDA has yet to decide whether to act on this conclusion and remove phenylephrine from its list of ingredients for over-the-counter use. Walgreens, a rival pharmacy chain, stated that it adheres to FDA regulations and is monitoring the situation.
Phenylephrine is an over-the-counter drug that has been used for decades to relieve congestion and stuffy nose caused by allergies or colds. It is said to work by reducing the swelling of blood vessels in the nasal passages. However, the FDA advisory panel found that oral forms of phenylephrine are ineffective, while nasal sprays and drops containing phenylephrine are still considered effective.
Researchers at the University of Florida questioned the efficacy of phenylephrine in 2007, leading to calls for its removal from store shelves. Recent studies have shown that phenylephrine products are no better than placebos in treating cold and allergy congestion. Dr. Zara Patel of Stanford Medicine explains that advancements in science and research have provided better data, leading to the updated conclusion.
Dr. J. Routt Reigart, chair of the American Academy of Pediatrics committee on drugs, mentions that most pediatricians do not intentionally prescribe phenylephrine-containing remedies, as its lack of effectiveness has been known for a long time. The reason why phenylephrine does not work well in oral form is that it is metabolized quickly, resulting in very little being absorbed into the bloodstream.
However, if you have used phenylephrine as directed in the past, there is no need to worry about new side effects or dangers. While it may not be effective, it does not pose any risks. Phenylephrine may seem to work for some individuals due to a placebo effect or because it is combined with other medications that provide relief for other cold or allergy symptoms.
The FDA will make the final decision on whether to follow the advisory panel’s recommendations and remove oral phenylephrine medications from store shelves. In the meantime, there are alternative options available. Nasal sprays like nasal antihistamine sprays are effective and can be purchased over-the-counter. Pseudoephedrine is another oral decongestant alternative but may require assistance from a pharmacist due to its potential for abuse. It’s important to note that some states have purchase limits or ID requirements for pseudoephedrine.
Additionally, topical steroid sprays, topical antihistamine sprays, and nasal sprays containing phenylephrine are still considered effective for relieving congestion. However, phenylephrine nasal sprays should only be used for a maximum of two to three days to avoid rebound congestion.
For children with allergies, saline nose drops or first-generation antihistamines like Benadryl can be beneficial for congestion. In general, for a typical cold or runny nose, it is recommended not to use any medication unless it is specifically for allergies.
This updated article was originally published on Sept. 13, 2023.
