WITH kids heading back to school and colder weather on the horizon, that time of year when everyone seems to have a cold is slowly but steadily approaching.
The US Food and Drug Administration is this week holding a meeting on whether an ingredient found in many over-the-counter cold and allergy medications actually works to ease nasal congestion.
Working to unclog your nose when you’re in the thick of a cold, flu or allergies, phenylephrine has been sold in liquid, pill and nasal spray form for more than 75 years both in the US and the UK, according to FDA documents released prior to the meeting.
Phenylephrine features in decongestants such as Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion.
It’s also one of the ingredients in Nurofen’s Cold & Flu relief medicines, Lemsip sachets and capsules, as well Beechams treatments for cold and flu.
Now, the American drug watchdog will examine whether medicines with the ingredient are effective in getting rid of nasal congestion, in meeting held on September 11 and 12.
The stakes are high, according to NBC, as a committee vote declaring phenylephrine ineffective could lead the FDA to revoke the drug’s over-the-counter designation as “generally recognised as safe and effective”, which allows makers of older drugs to include an ingredient in over-the-counter products without filing for an FDA application.
Such a move could result in treatments that contain it being pulled from shelves in the US.
It should be noted that the FDA isn’t questioning the effectiveness of nasal sprays that contain phenylephrine.
But in briefing documents, FDA scientists said that – although it has not found any safety issues with oral phenylephrine – data on the drug suggested that it is not effective as a nasal decongestant, even in high doses.
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, primary care physician at Massachusetts General Hospital, Dr Wynne Armand, told the outlet that she doesn’t prescribe it and tells patients to go for other over-the-counter medicines to treat cold and flu.
She said the drugs don’t work and could bring on added side effects, such as headaches, insomnia and nervousness.
When asked about whether 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 purchase in a supermarket.
“By the time they get to a community pharmacy, it is usually due to these preparations not working so we would recommend something stronger or a combined therapy,” he explained.
That might include treatments containing pseudoephedrine or steroid nasal spray, depending on the cause of patients’ congestion, Sadik went on.
According to the NHS, you can buy a pack of 12 pseudoephedrine tablets or 100 ml in liquid form from most pharmacies.
It also comes 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.
Questions around oral phenylephrine’s effectiveness in the US started up as early as 2007, after a group of pharmacists filed a Citizen Petition to pull the drug from shelves because of evidence that it was no better than a placebo.
They cited studies showing that when taken orally, a large portion of phenylephrine is metabolised in the gut and liver before it reaches the bloodstream, meaning a very small amount of the drug actually reaches the nose to relieve congestion.
The Sun asked the Medicines and Healthcare products Regulatory Agency (MHRA) if it plans to review oral phenylephrine’s effectiveness.
It’s chief safety officer, Dr Alison Cave, said: “Patient safety is our top priority.
“All available data is carefully considered when authorising any medicine and we continue to closely monitor all medicines for safety and effectiveness following authorisation, to ensure the benefits outweigh any risks.
“There have been no new safety concerns identified with phenylephrine containing products and people can continue to use as directed.
“If you have any concerns about a medicine you are taking, please seek advice from a healthcare professional.”