When stuffed up, most of us reach for an over-the-counter decongestant. But it turns out that the most popular oral decongestant in the country doesn’t work.
Phenylephrine is a key ingredient in many medications, including OTC Sudafed, Nyquil and Benadryl. It rose to prominence in the 2000s as it replaced pseudoephedrine. Pseudoephedrine can be made into an illegal drug and was moved behind the pharmacy counter; phenylephrine filled its place in the on-the-shelf marketplace. The drug generated almost $1.8 billion in sales last year. It is thought to work by decreasing swelling in blood vessels in the nose.
But new evidence shows it doesn’t work. In oral medications, not enough reaches the nose to aid congestion. A unanimous FDA panel called phenylephrine ineffective. They now have to decide whether to strip it of its label of being “generally recognized as safe and effective.”
If the drug is stripped of its designation, products containing it may need to be pulled from shelves and reformulated. Patient advocates say the move is long overdue as people deserve OTC meds that work.
The FDA reviewed the latest research and found that original studies of the drug weren’t methodologically sound and wouldn’t pass muster today. While spray versions of the drug work, oral applications don’t, and the side effects are more serious than originally believed. People have defended the drug, claiming that if it’s pulled from the market, there won’t be any medications to take its place. Doctors on the panel point out that pseudoephedrine is still available without a prescription. You just need to request it from the pharmacist. Arguing that nothing will be able to take a product’s place when it is proven not to work seems a bit odd.
While this might seem trivial, the problem is going to court in several states. A class-action suit claims that Johnson & Johnson knew that their OTC medications didn’t work.
“There’s a serious problem when a ‘decongestant’ doesn’t ‘decongest,’ and the FDA’s recent findings are a prime example of how the pharmaceutical industry makes billions by knowingly selling questionable products to consumers who are suffering from specific ailments,” said lawyer Adam Levitt.
“We filed the first national class action against a number of these companies who are making billions of dollars over a drug that was worthless,” said attorney Dan Thornburgh. His case is located in Florida, but others have gotten underway in other states.
You might want to pause before clearing out your medicine cabinet. The spray form of phenylephrine works. And other active ingredients in oral medications it’s present in may be effective. So, if the pills in your medicine cabinet have worked well for you in the past, you might not want to rush to throw them away. You may want to stick to the medications that have worked for you. It could be the placebo effect or one of the other ingredients. But, if it works, it works.