By Karen Kier
Pharmacist on behalf of the ONU HealthWise team
Mac Davis was a successful songwriter, singer and actor. He got his start in the music industry as a songwriter and employee for Nancy Sinatra and her company Boots Enterprises. He was a prolific songwriter for numerous artists. In 1968, he wrote A Little Less Conversation for Elvis Presley.
In 1974, Mac Davis released his album Stop and Smell the Roses, which peaked at number 2 on the country charts. He went on to star in his own television variety show as well as several movies. He sang God Bless the USA for the 50th Presidential Inauguration of Ronald Reagan. Mac Davis continued to write songs until is death on September 29, 2020.
It can be hard to smell the roses when you have a cold or a stuffy nose.
The topic of nasal decongestants has been in the news over the last two weeks. What has prompted this discussion?
In 2022, a citizens’ petition for removal of oral phenylephrine from over-the-counter status was submitted by three physicians to the FDA. The American Academy of Allergy, Asthma & Immunology released a supporting statement agreeing with the petition for removal of the decongestant from the market. This petition and supporting documentation provide strong clinical evidence for a lack of effectiveness with phenylephrine.
Prior to 1962, drugs submitted to the FDA for approval had to prove they were safe for the public. Congress in 1962 amended the Federal Food, Drug, and Cosmetic Act to include the requirement of drug effectiveness for approval in the United States. Since that time, the FDA has gone back and required submission of effectiveness for some drugs grandfathered prior to 1962.
In 1976, the FA evaluated the safety and effectiveness of oral decongestants including phenylpropanolamine (PPO), pseudoephedrine (PSE) and phenylephrine (PE). All three of these ingredients were found in popular nonprescription cold, flu, and allergy products. PPO was commonly seen in nonprescription weight loss products as well. In 2000, PPO was voluntarily removed from the market due to safety concerns related to increases in blood pressure and strokes.
The 2005 Combat Methamphetamine Epidemic Act regulated pseudoephedrine to specific restrictions including its removal from over-the-counter products. Pseudoephedrine commonly referred to as its brand name of Sudafed® could be sold by pharmacists behind the counter with quantity restrictions. The number of pills sold restriction reduced the abuse of buying the ingredient in large quantities to be converted into methamphetamine.
The change in status for PSE and PPO resulted in phenylephrine being the only oral decongestant available for over-the-counter cold, flu, and allergy products. The packaging often displays the PE abbreviation as part of the product name or branding.
The Citizens’ Petition provides evidence from a 2007 study indicating the oral PE product did not change nasal airway resistance (stuffiness) and was similar to the placebo effect. In addition, the physicians cited a 2015 study evaluating nasal congestion after administering PE in 4 different doses for allergy symptoms. No matter how high the dose including a dose 4 times higher than the 10 milligram PE dose approved for nonprescription status, PE did not improve nasal stuffiness compared to the patients’ baseline scores.
The FDA Advisory Committee discussed this petition at their meeting on September 11 and 12. The Committee determined there was evidence to support the lack of effect of oral PE as a nasal decongestant. The advisory report is a recommendation to the FDA and is not the final decision on the status of PE in nonprescription products. The FDA has not yet ruled on this finding so PE products are still available on the market.
So, what options would a consumer have if PE is removed from over-the-counter products?
Pseudoephedrine would be available as the only oral option.
However, phenylephrine nasal spray would not be included in the removal from the market. The PE nasal spray has been shown to improve congestion and stuffiness. The nasal application puts the PE product directly where it needs to work. Some other nasal spray decongestants contain the active ingredient oxymetazoline often referred to by the brand name Afrin®. The problem with these nasal sprays is they can only be used short-term. If the product is used for more than 3 days, individuals can suffer from rebound nasal congestion.
Other products such as saline nasal sprays can offer some relief as well. While antihistamines used for allergy symptoms do not specifically relieve nasal congestion, they can offer two benefits. They can prevent nasal congestion from allergy exposure and they have a drying effect on the nasal passages.
It is best to discuss the options with your pharmacist or healthcare provider for the best advice.
Open those nasal passages and stop to smell the roses!
ONU HealthWise is offering the flu vaccine Monday through Friday from 10 a.m. to 5 p.m. The pharmacy has ordered doses of the Moderna and Pfizer monovalent vaccines. Please call the pharmacy for availability.
ONU HealthWise Pharmacy
419-772-3784
