Cold Medicines | Over-the-counter decongestant ineffective, FDA concludes

Phenylephrine, a nasal decongestant found in many over-the-counter cold medications, is ineffective, a U.S. Medicines Agency (FDA) advisory panel unanimously concluded Tuesday.




“Modern studies, when done well, show no improvement in congestion with phenylephrine,” said Dr.r Mark Dykewicz, an allergy specialist at St. Louis University School of Medicine in Missouri.

There are two groups of over-the-counter decongestants: topical decongestants, which are sprayed directly into the nose, and oral decongestants, which regularly contain phenylephrine. It is this last product which was analyzed by the American group of experts.


PHOTO SARAH MONGEAU-BIRKETT, LA PRESSE ARCHIVES

Pharmacist, professor at the Faculty of Pharmacy at the University of Montreal and former MP Diane Lamarre

Phenylephrine is a vasoconstrictor [qui rétrécit les vaisseaux sanguins] effective when administered directly into the nose or eyes, but when taken by mouth, it is metabolized by the digestive system and loses its effectiveness.

Diane Lamarre, pharmacist and professor at the Faculty of Pharmacy at the University of Montreal

Researchers at the University of Florida had asked the FDA to withdraw most phenylephrine products, based on recent studies showing that they were no more effective than placebo pills in patients suffering from colds and allergic congestion. These same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.

A decision to come

The US agency must now decide whether products containing phenylephrine should be removed from store shelves in the United States. “As the FDA’s conclusion is that the product is not effective, there is not the same urgency for withdrawal as if a serious adverse effect had been identified,” explains Diane Lamarre.

Although it does not provide the desired relief from nasal congestion, oral phenylephrine is still combined with other ingredients that may provide some relief from other cold or flu symptoms, such as fever and cough, note Mme Lamarre.

It is likely that Health Canada will follow in the footsteps of the FDA, believes the president of the Order of Pharmacists of Quebec, Jean-François Desgagné. “We live on the same continent, and even if Health Canada is completely autonomous and independent, we can expect a decision to be made in the same direction here,” he said. However, he is not worried about the population. “There are many other solutions. »

Different options

In the event of nasal congestion due to a cold or flu, pharmacist Marie-Pascale Beaulieu, director of pharmaceutical services at the Quebec Association of Pharmacists Owners (AQPP), recommends instead switching to a saline water solution. “It’s the safest, most effective, and it’s what will have the fewest side effects. Of course, sometimes it can be less pleasant at the time, but that’s what will provide relief the quickest. »

Pharmacist and professor at the Faculty of Pharmacy at the University of Montreal Daniel Thirion also recommends the saline solution to be able to liquefy secretions. “But if you have a lot of fluid congestion, topical decongestants, for a short period of time, are very effective,” he says.

Pharmacist Diane Lamarre specifies that if nasal congestion is more associated with allergies, the first choice is to resort to a nasal corticosteroid and, if this is insufficient, antihistamines.

With the respiratory virus season approaching, professionals are unanimous: if necessary, do not hesitate to ask your pharmacist for advice.

With the Associated Press


source site-61