Many popular decongestant cold medicines do not work, says US report

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And now, the Food and Drug Administration (FDA) must decide whether products containing the ingredient should be withdrawn from the market, or if it should give companies time to substitute other ingredients.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

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