You’re sniffling, sneezing, and sleepless from coughing — and your head is killing you. You have just one question: What will put an end to this suffering?
Unfortunately, the over-the-counter remedy in your medicine cabinet probably won’t help. On Tuesday, an advisory group to the Food and Drug Administration concluded that a common decongestant, phenylephrine, found in Sudafed PE, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, DayQuil, Theraflu Severe Cold Relief, Mucinex Sinus Max, and some 250 other medications doesn’t actually relieve congestion.
So what will work? Experts say there’s no magic pill or potion to help you feel better.
“There is no ideal solution that you can point to and say this particular drug is going to be highly effective in most people,” said Dr. Daniel R. Kuritzkes, chief of the Division of Infectious Diseases at Brigham and Women’s Hospital.
Home remedies are often a better option than anything on the pharmacy shelves, said Dr. Kristina Orio, chief medical officer for five Boston-area urgent care centers owned by the national chain American Family Care.
She recommends steam and neti pots, which soothe and hydrate the nasal passages. Menthol cough drops can open up the sinuses.
Doctors say that rest, hydration, perhaps acetaminophen or ibuprofen for headache or fever — along with a big dose of patience — are all that’s needed, as the cold will run its course.
But if your cold lasts more than five or seven days, or is worsening with time, Orio advises a medical visit, in case you have a secondary infection or an illness more serious than a cold.
Phenylephrine works when used in eyedrops or nasal sprays, said Dr. Wynne Armand, associate director of Massachusetts General Hospital’s Center for the Environment and Health. But when taken as a pill or syrup, it’s broken down in the gut and never reaches your nose.
Even the nasal spray, though, works only for a few days, Kuritzkes said.
Questions about the effectiveness of phenylephrine have been brewing for some time. Drug makers started adding the drug to medicines after a 2005 law required that another decongestant — pseudoephedrine, the active ingredient in Sudafed — could be sold only from behind the pharmacy counter, because it was being used in the manufacture of methamphetamines. Although pseudoephedrine remains available without a prescription and is effective, the need to ask the pharmacist for it has deterred some customers. Drug makers looked for a more convenient alternative, and added phenylephrine.
In 2007, two pharmacists from the University of Florida petitioned the Nonprescription Drug Advisory Committee, an advisory group to the FDA, to remove phenylephrine from the list of decongestants classified as “Generally Recognized as Safe and Effective.” The pharmacists presented data raising questions about the drug’s effectiveness.
But the committee said that more data were needed. Since then three large clinical trials and additional studies have been conducted, all finding that when taken by mouth, phenylephrine does not reduce nasal congestion. No safety problems have been identified.
“It’s very rare that anyone raises an efficacy question” about over-the-counter drugs, said Frances H. Miller, professor emeritus at the Boston University School of Law, “because people pay for them out of pocket.” Since they’re not paying for it, insurance companies aren’t questioning whether the drug is worth the money.
But the pharmacists who petitioned the committee “pushed the issue,” Miller said. “They saw it, they pushed it. For whatever constellation of reasons, the FDA said it couldn’t ignore it.”
Now that the committee has found the drug ineffective, the FDA could remove it from the list of allowable ingredients for over-the-counter medications, but Miller considers that unlikely.
As the committee’s report notes, banning the drug would cause significant disruption for the industry, which has invested in supplies of phenylephrine and would have to retool many cold remedies.
“It probably will happen on its own,” she said: The publicity will drive people to stop taking the medications that contain it.
Asked if she was surprised to learn that people had been taking an ineffective drug for nearly two decades, Miller laughed. “No, never,” she said. People take lots of ineffective substances and the placebo effect is powerful, she said. “They think that by taking stuff they’ll be better,” she said. “If they believe that, they will.”
Some doctors say that it was never a good idea to take medications that contain multiple drugs targeting different cold symptoms all at once. Such formulations can cause drowsiness and often contain acetaminophen, the active ingredient in Tylenol. People who don’t realize the medicine already includes acetaminophen can easily overdose if they take more. Additionally these mixtures often contain antihistamines and alcohol, which can be highly sedating.
“It’s best to target the symptom you want to treat, the most bothersome symptom of the cold or allergies,” said Armand, of Mass. General. “If somebody is trying to treat their cough, they are going to want to take cough suppressants, or if they want to target their fever they should take acetaminophen or ibuprofen, to just name the common ones.”
But even cough suppressants’ effectiveness is doubtful. “Most of the trials that have looked at cough syrups have not been very compelling. It’s not clear they make a difference,” said Orio, of American Family Care. And while pseudoephedrine (or Sudafed) effectively reduces congestion, it can raise blood pressure and is not recommended for people with hypertension or rapid heartbeats, she said.
“We would love to have a pill that makes us better,” Orio said. “Whether it’s allergies or viruses, these things need to run their course.”