Coughing and spluttering? If you think it might require a decongestant, don’t waste your money on over-the-counter (OTC) medications that contain phenylephrine. 

A new report from the US says a decongestant in popular cold medicines doesn’t work – at all. 

And now, the Food and Drug Administration (FDA) must decide whether products containing the ingredient should be withdrawn from the market, or if it should give companies time to substitute other ingredients.

The ingredient, phenylephrine, is found in American products like Tylenol, Mucinex and Benadryl.

In South Africa, some of our most trusted over-the-counter flu and cold medications contain phenylephrine: Rinex, Corenza C, Corenza Para-C and MedLemon.

Phenylephrine has replaced pseudoephedrine in many over-the-counter medications since the latter became more restricted in the US, Europe and in South Africa due to concerns around their use as an ingredient for the illicit manufacture of methamphetamine (tik).

It remains an effective medication and in South Africa, when in combination with other ingredients, it can still be bought as an over-the-counter medicine.

The New York Times reports that an advisory panel to the FDA agreed unanimously this week that phenylephrine – taken orally – is ineffective, which means that it now needs to decide whether to ban the ingredient. This would entail pulling hundreds of products containing it from store shelves.

If the FDA withdraws products containing phenylephrine, pharmaceutical companies would have to reformulate them.

The FDA says any action in this regard will have significant downstream effects in the US, including effects on both industry and consumers, because the only other oral decongestant listed in the cough, cold, allergy, bronchodilator and anti-asthma over-the-counter monograph (a document that reflects the quality attributes of medicines approved by the FDA) is pseudoephedrine, which is now regulated as a “behind-the-counter” (scheduled) product under the Combat Methamphetamine Epidemic Act of 2005.

In response to this act, most over-the-counter products were reformulated to substitute pseudoephedrine with phenylephrine. New consumer education will also be required. 

In an FDA briefing document dated 11 September, the agency says it is mindful that withdrawing the ingredient from the market would have a significant impact on the pharmaceutical industry. 

“Manufacturers, warehousers and pharmacies all have a significant supply chain investment in stocks of PE (phenylephrine), either as a precursor chemical, ingredient or in a finished product. There will also be significant retooling costs. In addition to OTC products, prescription products and drug development programmes will be affected.”

However, withdrawing the products from sale would help prevent consumers from incurring unnecessary costs and delaying their care by taking a drug that has no benefit, avoiding the risks of potential allergic reactions or other side effects related to use of phenylephrine in combination products, avoiding the inherent risks of taking more in order to seek some benefit, avoiding the risks of medication use in children, lowering of overall healthcare costs, and avoiding missed opportunities for use of more effective treatments (including seeing a doctor if needed).

The New York Times says the findings could be contested, which could delay product substitutions or the withdrawal of stock.

However, while phenylephrine, taken orally, does not relieve nasal congestion, it is not harmful and it may be that other ingredients in the affected medications could work to ease cold symptoms.

Maria Coyle, the chair of the panel and an associate professor of pharmacy at Ohio State University, told the newspaper: “I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug.”

Another pharmacist, Dr Leslie Hendeles from the University of Florida, who, along with colleagues, first petitioned the FDA in 2007 to remove the drug from the market, said: “If you have a stuffy nose and you take this medicine, you will still have a stuffy nose.”

Nasal sprays that contain the ingredient are still considered effective, as well as when it is used in surgery or to dilate the eyes. 

Waiting for Sahpra

In South Africa, the South African Health Products Regulatory Authority (Sahpra) provides guidance on health product safety, efficacy and quality.

Both retail pharmacy groups Clicks and Dischem referred queries to Sahpra, which failed to respond.

Aspen Pharmacare – which manufactures Flutex and Rinex – also failed to respond. 

Jeremy Nicol, managing director for S Buys Pharmacy at Spar, explained that all South African pharmacists and pharmacies were waiting for directions from Sahpra. 

“At this moment, no action will be taken until we receive official guidance from Sahpra. Pharmacies will continue to stock products containing phenylephrine in accordance with Sahpra’s recommendations, and remove stock immediately should we get that directive.”

But Jackie Maimin, the CEO of the Independent Community Pharmacist Association, assured consumers that phenylephrine has been an ingredient in cold and flu remedies, including cough mixtures, for decades. 

“These products have been registered by our medicines regulatory body, (Sahpra) and are considered safe and effective by both consumers and healthcare professionals. That has not changed.

“If the latest research shows that phenylephrine, as an ingredient in a cold and flu remedy, is no better than a placebo, then we will wait to be guided by Sahpra. 

“In the meantime, the public should not panic – in many cases, the ‘placebo’ effect has shown to be quite effective on its own, and the evidence is not showing that phenylephrine is harmful. 

“There are no oral medicines with phenylephrine alone; it is always with other ingredients. If anyone is concerned, please speak to your pharmacist who will be able to advise further.”

Dr Thiruvasan Govindsamy, the head of medical affairs at Adcock Ingram, which produces Corenza C, Grippon and other products, told Daily Maverick that they were aware of The New York Times report. 

“Adcock Ingram supplies pharmaceutical products across a broad range of therapeutic categories which include cold and flu products, certain of which contain phenylephrine as an active ingredient in combination with other active ingredients.

“We are monitoring the situation for final recommendations, if any, from the FDA.”

Again, they too were awaiting guidance and recommendations from Sahpra, as only it has the authority to determine which medicines are registered for use in the local market. DM

Correction: The previous version of this article listed Ventolin as one of the affected products. That is inaccurate – Ventolin is a bronchodilator.