The ramp-up to cold and flu season is a bad time for consumers to learn that some of their most trusted go-to products don’t actually work.

An advisory committee to the U.S. Food and Drug Administration concluded unanimously in September 2023 that phenylephrine – an active ingredient found in popular over-the-counter cough and cold products such as Sudafed PE, Theraflu and NyQuil Severe Cold and Flu – works no better than a placebo when taken orally. The 2023 FDA advisory panel met to review growing evidence that oral phenylephrine is an ineffective treatment for nasal congestion. The committee did not review the effectiveness of phenylephrine nasal spray.

In response, CVS, one of the largest pharmacy chains in America, announced that they will no longer sell products that contain oral phenylephrine as the only active ingredient in its community pharmacies.

To the millions of Americans who will suffer from colds with stuffy noses this fall and winter – many of whom have used products containing phenylephrine for years – the panel’s decision may be startling.

Consumers are likely wondering whether they should stop using over-the-counter products containing phenylephrine, whether the products will still be on the shelves this winter and what other options they might have. Consumers may also question whether combination cough, cold and flu products will still be safe and effective for use at home.

As the FDA considers the advisory committee’s conclusions, oral phenylephrine will still likely be sold at many pharmacies despite the fact that more effective nonprescription medications and nonmedication approaches to relieve congestion exist.

As pharmacists who are focused on patient care in local communities, we have some advice on what to do when you need relief from cold and flu symptoms.

The backstory

As of fall 2023, phenylephrine is listed as the sole active ingredient, or as one of the active ingredients, in thousands of over-the-counter products, including tablets, liquids, nasal sprays, gels and ointments.

The medication, when taken as an oral tablet, oral liquid or nasal spray, has long been used for the temporary relief of sinus or nasal congestion from the common cold or seasonal allergies. Phenylephrine has been the only oral decongestant on pharmacy and grocery store shelves since another popular decongestant, pseudoephedrine, became more regulated and went behind the counter in 2006.

The most recent analysis is not the first time an FDA advisory panel has scrutinized oral phenylephrine. A 2007 panel examining its use concluded that more studies were needed to make a final decision regarding the effectiveness of phenylephrine.

Additional studies since then showed no difference in efficacy between phenylephrine and a placebo, likely because phenylephrine taken by mouth is inactivated in the gut.

Safety concerns

No safety issues with oral phenylephrine alone were documented in the 2023 advisory panel conclusion. However, researchers and advisory panel members have raised concerns about the possibility of products containing ineffective phenylephrine remaining on pharmacy shelves.

Even if oral phenylephrine is safe, taking an ineffective medication could cause consumers to spend money on products that work no better than a placebo. A placebo effect is a well-known phenomenon in which people taking an inactive product may perceive benefit. The placebo tablets used in the phenylephrine studies were the same or similar shape and color as the phenylephrine tablets but without the active ingredient.

The panel also noted the missed opportunities for pharmacists to recommend something more effective for nasal congestion if phenylephrine remains commercially available.

Despite the advisory committee’s conclusions, no official action has been taken by the FDA as of late October 2023. If the agency proposes a change in the availability of phenylephrine, consumers will be asked to weigh in prior to a final ruling.

The story behind pseudoephedrine

Luckily, the nonprescription oral nasal decongestant pseudoephedrine – which is known to be effective – has been commercially available for many years. This drug is available as a single ingredient product or in combination with other ingredients in products marketed to treat sinus congestion.

Pseudoephedrine is a nasal decongestant that is taken by mouth to relieve a stuffy nose. It works by constricting the blood vessels that become enlarged as a result of a cold, flu or seasonal allergies.

But buying products containing pseudoephedrine is not as straightforward as it sounds. Because pseudoephedrine can be used to manufacture the street drug methamphetamine, the FDA requires that it be sold behind the counter and in limited amounts each day and month. It also requires photo identification at the point of sale.

If the FDA acts on the advisory committee’s conclusions that oral phenylephrine is not an effective nasal decongestant, pseudoephedrine may be the only remaining oral medication available without a prescription to treat nasal congestion. Here are some things to know about pseudoephedrine:

• Pseudoephedrine should not be used in doses higher than those that are recommended on the label. Use of products containing pseudoephedrine should be stopped and a health care provider consulted if dizziness, nervousness or sleeplessness occurs.

• Pseudoephedrine should not be used by consumers with heart disease, high blood pressure, thyroid disease, diabetes or an enlarged prostate without talking with a health care provider like a pharmacist or a physician.

• Products with pseudoephedrine should not be used while taking, or within two weeks of stopping, a prescription monoamine oxidase inhibitor, which is most commonly used to treat for depression or Parkinson’s disease.

Other treatments

In addition to oral pseudoephedrine, medicated nasal sprays – including those containing phenylephrine or oxymetazoline as active ingredients – can also relieve nasal congestion. These products are sold under the brand name Afrin and others.

However, medications are not the only way to relieve congestion. Some non-drug approaches include hot, steamy showers, safe use of neti pots, vaporizers or humidifiers, saline nasal spray and applying a warm, moist washcloth to the face. All of these non-drug approaches can help sooth the nasal passage to provide temporary relief from congestion. If symptoms of congestion continue for more than two weeks, or if signs of an infection arise, go see your doctor.

Since products containing oral phenylephrine will remain on the market for the time being, it is critical for consumers to read the labels of over-the-counter products and review the active ingredients and their risks.

You should talk with your pharmacist about your symptoms, medical conditions and the other medications you’re taking prior to purchasing any over-the-counter product. Your pharmacist will help you determine if your symptoms can be managed with self-care or if you need to see a physician.

Lucas A. Berenbrok, Associate Professor of Pharmacy and Therapeutics, University of Pittsburgh; Colleen Culley, Associate Professor of Pharmacy, University of Pittsburgh, and Karen Steinmetz Pater, Associate Professor of Pharmacy, University of Pittsburgh

This article is republished from The Conversation under a Creative Commons license. Read the original article.

For centuries, the quest for new elements was a driving force in many scientific disciplines. Understanding an atom’s structure and the development of nuclear science allowed scientists to accomplish the old goal of alchemists – turning one element into another.

Over the past few decades, scientists in the United States, Germany and Russia have figured out how to use special tools to combine two atomic nuclei and create new, superheavy elements.

These heavy elements usually aren’t stable. Heavier elements have more protons, or positively charged particles in the nucleus; some that scientists have created have up to 118. With that many protons, the electromagnetic repulsive forces between protons in the atomic nuclei overwhelm the attractive nuclear force that keeps the nucleus together.

Scientists have predicted for a long time that elements with around 164 protons could have a relatively long half-life, or even be stable. They call this the “island of stability” – here, the attractive nuclear force is strong enough to balance out any electromagnetic repulsion.

Since heavy elements are difficult to make in the lab, physicists like me have been looking for them elements everywhere, even beyond the Earth. To narrow down the search, we need to know what sort of natural processes could produce these elements. We also need to know what properties they have, like their mass densities.

Calculating density

From the outset, my team wanted to figure out the mass density of these superheavy elements. This property could tell us more about how the atomic nuclei of these elements behave. And once we had an idea about their density, we could get a better sense of where these elements might be hiding.

To figure out the mass density and other chemical properties of these elements, my research team used a model that represents an atom of each of these heavy elements as a single, charged cloud. This model works well for large atoms, particularly metals that are laid out in a lattice structure.

We first applied this model to atoms with known densities and calculated their chemical properties. Once we knew it worked, we used the model to calculate the density of elements with 164 protons, and other elements in this island of stability.

Based on our calculations, we expect stable metals with atomic numbers around 164 to have densities between 36 to 68 g/cm³ (21 to 39 oz/in³). However, in our calculations, we used a conservative assumption about the mass of atomic nuclei. It’s possible that the actual range is up to 40% higher.

Asteroids and heavy elements

Many scientists believe that gold and other heavy metals were deposited on Earth’s surface after asteroids collided with the planet.

The same thing could have happened with these superheavy elements, but super mass dense heavy elements sink into ground and are eliminated from near the Earth’s surface by the subduction of tectonic plates. However, while researchers might not find superheavy elements on Earth’s surface, they could still be in asteroids like the ones that might have brought them to this planet.

Scientists have estimated that some asteroids have mass densities greater than that of osmium (22.59 g/cm³, 13.06 oz/in³), the densest element found on Earth.

The largest of these objects is asteroid 33, which is nicknamed Polyhymnia and has a calculated density of 75.3 g/cm³ (43.5 oz/in³). But this density might not be quite right, since it’s quite difficult to measure the mass and volume of far-away asteroids.

Polyhymnia isn’t the only dense asteroid out there. In fact, there’s a whole class of superheavy objects, including asteroids, which could contain these superheavy elements. Some time ago, I introduced the name Compact Ultradense Objects, or CUDOs, for this class.

In a study published in October 2023 in the European Physical Journal Plus, my team suggested some of the CUDOs orbiting in the solar system might still contain some of these dense, heavy elements in their cores. Their surfaces would have accumulated normal matter over time and would appear normal to a distant observer.

So how are these heavy elements produced? Some extreme astronomical events, like double star mergers could be hot and dense enough to produce stable superheavy elements.

Some of the superheavy material could then remain on board asteroids created in these events. They could stay packed in these asteroids, which orbit the solar system for billions of years.

Looking to the future

The Eurpoean Space Agency’s Gaia mission aims to create the largest, most precise three-dimensional map of everything in the sky. Researchers could use these extremely precise results to study the motion of asteroids and figure out which ones might have an unusually large density.

Space missions are being conducted to collect material from the surfaces of asteroids and analyze them back on Earth. Both NASA and the Japanese state space agency JAXA have targeted low density near-Earth asteroids with success. Just this month, NASA’s OSIRIS-REx mission brought back a sample. Though the sample analysis is just getting started, there is a very small chance it could harbor dust containing superheavy elements accumulated over billions of years.

One mass-dense dust and rock sample brought back to Earth would be enough. NASA’s Psyche mission, which launched in October 2023, will fly to and sample a metal-rich asteroid with a greater chance of harboring superheavy elements. More asteroid missions like this will help scientists better understand the properties of asteroids orbiting in the solar system.

Learning more about asteroids and exploring potential sources of superheavy elements will help scientists continue the century-spanning quest to characterize the matter that makes up the universe and better understand how objects in the solar system formed.

Evan LaForge, an undergraduate student studying physics and mathematics, is the lead author on this research and helped with the writing of this article, along with Will Price, a physics graduate student.

Johann Rafelski, Professor of Physics, University of Arizona

This article is republished from The Conversation under a Creative Commons license. Read the original article.