Phenylephrine, a widely sold nasal decongestant, is ineffective when taken orally, offering no clinical benefit compared to a placebo. This is the main finding of a thorough review of all the scientific evidence conducted by a United States Food and Drug Administration (FDA) advisory board. This finding doesn’t apply to other forms of administering phenylephrine (ophthalmic, nasal or intravenous) as the ingredient’s effectiveness in these forms hasn’t been disproven.
The FDA review could lead to the removal of phenylephrine from American pharmacy shelves, a crucial market for the global pharmaceutical industry, which would have to replace the ingredient with another decongestant with proven effectiveness. Ineffective drugs should be withdrawn and replaced as the risks outweigh the advantages – all medications have side effects, even if they are mild and infrequent.
A similar review of phenylephrine has not been initiated in Europe, but the Spanish Agency for Medicine and Health Products (AEMPS) believes that the European Union must now take action. “Given the significance of the [FDA] decision that impacts numerous authorized medicines, it is imperative to address this matter within the European Medicines Agency (EMA),” stated AEMPS in a written response to a query by this newspaper.
“Phenylephrine is included in medications to induce vasoconstriction, thereby reducing blood flow to the nasal passage and alleviating inflammation. But this review found that it does not have the expected efficacy as a decongestant. This is an example of how we learn as science progresses,” said Carlos Fernández Moriano, who is responsible for scientific dissemination at Spain’s General Council of Pharmaceutical Colleges, the profession’s representative body.
Fernández says that medicines with phenylephrine usually include an analgesic (paracetamol, ibuprofen, acetylsalicylic acid), an antihistamine (chlorphenamine), and a cough suppressant (dextromethorphan). “The goal is to provide symptomatic relief for colds or allergies that manifest as fever, headache and nasal congestion,” he said. None of these medications are publicly funded, and most are available without a prescription, except for those containing high doses of paracetamol or active ingredients like codeine.
“I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug,” said Maria Coyle, the chairperson of the FDA panel. Leslie Hendeles, another FDA panelist and pharmacist from the University of Florida, told The New York Times, “If you have a stuffy nose and you take this medicine, you will still have a stuffy nose.”
Other decongestants could replace phenylephrine
The experts we consulted say alternative decongestants with proven effectiveness are oxymetazoline and pseudoephedrine, which could replace phenylephrine if it is withdrawn from the US market. However, the EMA is currently investigating the safety of pseudoephedrine due to some reported serious side effects on brain blood vessels. Ana Padilla, a physician with La Fe Hospital in Valencia (Spain) believes reviews like the one carried out by the FDA are very important. “Proper evaluation of new medications is rightfully emphasized, but it is equally important to reassess the effectiveness of long-standing drugs on the market. However, this is often neglected, except for instances involving public health or safety concerns. As such, many drugs remain in a state of uncertainty. The FDA initiative is intriguing, and regulatory agencies should adopt and expand upon it.”
Most pharmaceutical companies that sell over-the-counter (OTC) products have one or more medications with phenylephrine, including well-known brands like Sudafed PE, Benadryl Allergy D Plus Sinus and Vicks DayQuil Cold and Flu Relief. The phenylephrine molecule is also produced and marketed by several of the largest generic drug companies.
Bayer’s Aspirina Complex granulated effervescent cold medicine with phenylephrine is sold in Spain and other countries. The company said it was “surprised” by the FDA’s conclusion, but that it is only “a recommendation until the agency makes the final decision.” The pharmaceutical company is confident that the US regulator “will consider the weight of scientific evidence supporting the safety and effectiveness of oral phenylephrine as a nasal decongestant, the extensive body of rigorous scientific studies spanning nearly five decades, the Koller meta-analysis of relevant clinical studies, and the two previous recommendations from FDA expert committees.”
The Ferrer pharmaceutical company, who also markets a cold medicine (Gelocatil Gripe Forte) with phenylephrine, said, “The Spanish Medicines Agency has evaluated and approved this medicine, including the effectiveness of its ingredients such as phenylephrine, as stated in the product’s current technical sheet. The company also collaborates closely with regulatory agencies to incorporate any required updates regarding the applicable legislation for our products.”
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