FDA is going to re-evaluate common over-the-counter nasal congestion medications over concerns it’s useless

Can Benadryl and Sudafed be taken off pharmacy shelves? FDA is going to review commonly used over-the-counter cold medicines over concerns they are useless

  • Scientists have believed for years that the nasal decongestant is ineffective
  • An FDA panel will weigh whether the popular medication has any medical benefits
  • It is a common alternative to the ingredient in Sudafed that can make meth



<!– <!–




Health officials are reevaluating the key ingredient in common nasal congestion and cold medications amid growing evidence that it doesn’t work.

For years, the main ingredient in a wide variety of over-the-counter oral decongestants was thought to be ineffective.

When phenylephrine is metabolized in the gut, it cannot reach the bloodstream in sufficient amounts, negating its ability to provide relief.

The FDA’s decision to reconsider the ingredient’s designation as “generally recognized as safe and effective” in April comes about eight years after a meta-analysis found it to be no more effective than a placebo.

Phenylephrine — commonly found in drugs such as Vicks Sinex, Delsym for children, and certain types of Sudafed — became extremely popular in the mid-2000s when the federal government placed new restrictions on the purchase of pseudoephedrine, an ingredient that can be used in clandestine labs to to make meth.

Benadryl Allergy Plus (above) contains the drug Phenylephrine

The drug Phenylephrine became incredibly popular in the wake of new government restrictions on the purchase of Sudafed, the active ingredient in which meth can be made

The drug Phenylephrine became incredibly popular in the wake of new government restrictions on the purchase of Sudafed, the active ingredient in which meth can be made

Scientists already knew in 2007 that the drug phenylephrine is an ineffective nasal decongestant

The FDA’s Advisory Committee on Over-the-Counter Drugs will deliberate whether or not to withdraw the “generally recognized as safe” oral designation of phenylephrine given the ‘lack of efficacy’.

Oral phenylephrine is a key ingredient in Sudafed PE. The combination of oral phenylephrine with the antihistamine diphenhydramine is marketed as several popular cold medications and decongestants, such as Benadryl Allergy Plus Congestion, Robitussin Night Time Cough and Cold, and Delsym Children’s Night Time Cough and Cold.

The drug works by shrinking the dilated blood vessels in the nose, relieving nasal and sinus congestion.

The FDA’s plan to weigh the medication’s regulatory future comes from years of evidence pointing to its futility as a decongestant.

Studies show that the drug works in the form of a nasal spray. But when taken orally, only a minuscule amount reaches the bloodstream, rendering it ineffective.

In 2007, pharmacy professors at the University of Florida filed a petition asking the FDA to review whether a 10-milligram pill of phenylephrine worked as a decongestant.

Since then, a series of studies have emerged pointing to its ineffectiveness.

2015, A study sponsored in part by New Jersey-based pharmaceutical company Merck & Co found that the 10 milligram dose, as well as the 20, 30, or 40 milligram doses, “were not significantly better than placebo in relieving nasal congestion” in a sample of 539 adults .

The FDA recommends taking 10 milligrams of this over-the-counter decongestant every four hours for temporary relief from nasal congestion.

A few months after that study was published in the Journal of Allergy and Clinical Immunology, pharmacy experts at the University of Florida launched a second petition demanding that the FDA remove the oral medication completely from the market.

Dr. Leslie Hendeles, professor of pharmacotherapy and co-author of the UF petition said in 2015: ‘Scientific evidence continues to show that the most popular products on the market containing phenylephrine are ineffective.

“Patients seeking an over-the-counter remedy should get what they pay for: an effective and safe alternative to a prescription drug.”

While the drug is widely believed to have no significant benefit, there is no strong evidence that it poses a safety threat.

Dr. Randy Hatton, a professor of pharmacy at UF and a co-author of the petition, said: “We believe the evidence supports the need to change the status of phenylephrine as a safe and effective over-the-counter product.”

“We look forward to the consumer, and he or she needs to know that the science says oral phenylephrine doesn’t work for most people.”

The petition received support from the American Academy of Allergy, Asthma & Immunology, which said last May“Over the counter oral phenylephrine is a disservice to patients who may be inclined to take higher doses than recommended due to lack of effect and/or delay their visit to their GP or specialist who can help resolve their symptoms.”


%d bloggers like this: