As the kids go back to school and colder weather looms, we’re slowly but steadily approaching that time of year when everyone seems to have a cold.
Feeling congested and sniffly is one of the unpleasant side effects of the season – but what if the pills you take to treat it don’t really do much?
The U.S. Food and Drug Administration is holding a meeting this week about whether an ingredient found in many over-the-counter cold and allergy medications actually works against nasal congestion.
Phenylephrine is used to clear your nose when you’re in the middle of a cold, flu, or allergies. Phenylephrine has been sold in liquid, pill and nasal spray forms in both the United States and the United Kingdom for more than 75 years, according to published FDA documents prior to the meeting.
Phenylephrine is found in decongestants such as Sudafed PE, Vicks Sinex, and Benadryl Allergy Plus Congestion.
It is also one of the ingredients in Nurofen’s cold and flu medicines, Lemsip sachets and capsules and Beechams cold and flu treatments.
Now, at its meeting on September 11th and 12th, the US drug regulator will examine whether drugs containing this ingredient are effective in clearing nasal congestion.
According to NBC, the stakes are high as a committee vote declaring phenylephrine ineffective could result in the FDA revoking the drug’s over-the-counter designation as “generally recognized as safe and effective,” which allows manufacturers of older drugs to use an ingredient to be included in over-the-counter products without submitting an application to the FDA.
Such a move could result in treatments containing it being removed from shelves in the United States.
It should be noted that the FDA does not question the effectiveness of nasal sprays containing phenylephrine.
But in briefing documents, FDA scientists said that while no safety problems were found with oral phenylephrine, data on the drug suggested it was not effective as a nasal decongestant, even at high doses.
The allergist and immunologist at Allergy & Asthma Associates of Murray Hill, Dr. Purvi Parikh, told NBC that oral phenylephrine is ineffective and “should almost never be used.”
Meanwhile, Massachusetts General Hospital family physician Dr. Wynne Armand told the outlet that she does not prescribe it and recommends patients take other over-the-counter medications to treat colds and flu.
She said the medications don’t work and can cause additional side effects such as headaches, insomnia and nervousness.
When asked if he would recommend phenylephrine products to a patient, Sadik Al-Hassan – a pharmacist at PillTime Pharmacy in Bristol – told Sun Health they are mild decongestants that most people would buy at the supermarket.
“When they arrive at a public pharmacy, it is usually because these preparations do not work. We would therefore recommend something stronger or a combination therapy,” he explained.
These could include treatments with pseudoephedrine or steroid nasal spray, depending on the cause of the patient’s nasal congestion, Sadik continued.
According to the NHS, you can buy a pack of 12 pseudoephedrine tablets or 100ml in liquid form from most pharmacies.
It is also mixed with other medicines to treat the symptoms of coughs, colds, and allergies, including Benadryl Allergy Relief, Benylin Day & Night, and Boots Chesty Cough & Congestion Relief.
The question of the effectiveness of oral phenylephrine was raised in the United States back in 2007, after a group of pharmacists filed a citizen petition to remove the drug from shelves because of evidence suggesting it was no better than a placebo.
They cited studies showing that when taken orally, a large portion of phenylephrine is metabolized in the intestines and liver before entering the bloodstream, meaning that only a very small amount of the drug actually reaches the nose, to relieve constipation.
The Sun asked the Medicines and Healthcare products Regulatory Agency (MHRA) whether it plans to review the effectiveness of oral phenylephrine.
The Chief Safety Officer, Dr. Alison Cave, said: “Patient safety is our top priority.
“All available data are carefully considered when a medicine is approved and we continue to closely monitor all medicines for safety and effectiveness even after approval to ensure that the benefits outweigh any risks.”
“No new safety concerns have been identified with phenylephrine-containing products and people can continue to use them as directed.
“If you have any concerns about any medicine you are taking, please contact a doctor.”