{"id":26720,"date":"2023-09-12T12:09:03","date_gmt":"2023-09-12T16:09:03","guid":{"rendered":"https:\/\/platohealth.ai\/fda-panel-says-common-otc-decongestant-phenylephrine-is-useless-drugs-com-mednews\/"},"modified":"2023-09-13T06:19:36","modified_gmt":"2023-09-13T10:19:36","slug":"fda-panel-says-common-otc-decongestant-phenylephrine-is-useless-drugs-com-mednews","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-panel-says-common-otc-decongestant-phenylephrine-is-useless-drugs-com-mednews\/","title":{"rendered":"FDA Panel Says Common OTC Decongestant, Phenylephrine, Is Useless – Drugs.com MedNews","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

By Dennis Thompson HealthDay Reporter<!—-><\/p>\n

TUESDAY, Sept. 12, 2023 — For decades, sick people have been taking essentially worthless over-the-counter cold remedies to clear their stuffy noses, a key advisory panel for the U.S. Food and Drug Administration said Tuesday.<\/p>\n

The panel voted unanimously that nonprescription oral medications containing phenylephrine<\/a> — including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion — don\u2019t do anything to ease congestion.<\/p>\n

The committee\u2019s ruling could prompt the FDA to pull all oral decongestants containing phenylephrine from store shelves, leaving cold sufferers with limited options to relieve their misery.<\/p>\n

\u201cI feel this drug in this oral dose should have been removed from the market a long time ago,\u201d said Jennifer Schwartzott, the patient representative on the panel, the Associated Press<\/em> reported. \u201cPatients require and deserve medications that treat their symptoms safely and effectively, and I don\u2019t believe that this medication does that.\u201d<\/p>\n

Phenylephrine has been available in cold remedies since the 1970s, and can be taken as a liquid, pill or nasal spray. Tuesday\u2019s decision does not include the nasal spray version.<\/p>\n

Medications with phenylephrine took on more prominence after the highly effective decongestant pseudoephedrine became harder to purchase in 2005, as part of legislation aimed at combatting the meth epidemic.<\/p>\n

More than 242 million bottles or packages of phenylephrine-containing cold remedies were sold in 2022, compared with about 51 million cold products containing pseudoephedrine, FDA briefing documents<\/a> for the meeting show.<\/p>\n

\u201cEver since pseudoephedrine went \u2018behind the counter\u2019 in the 2000s, phenylephrine became one of the most commonly available and widely used decongestants,\u201d said Dr. William Fox<\/a>, an internal medicine doctor in Charlottesville, Va.<\/p>\n

\u201cIt is easy to pick up from the drug store shelf, and it lacks the barriers that come with obtaining pseudoephedrine from the pharmacist, which typically require verifying your identity with a driver’s license — or in some states requiring an outright prescription,\u201d Fox added.<\/p>\n

But recent clinical trials, lab studies and evidence reviews caused the FDA to question the effectiveness of phenylephrine.<\/p>\n

The more recent trials show that the current recommended dosage of phenylephrine is not effective in patients suffering from allergies, the briefing documents say.<\/p>\n

\u201cWe believe that these new clinical pharmacology and clinical data are consistent, substantial and believable, and they confirm that orally administered phenylephrine is not effective at any dose that can be developed and still provide a reasonable margin of safety,\u201d the documents say.<\/p>\n

This prompted the FDA to review the studies that had been used to approve phenylephrine.<\/p>\n

\u201cWe noted significant methodological and statistical issues with the design and conduct of the original studies submitted to and evaluated by the panel,\u201d the documents state.<\/p>\n

The problem appears to be that the body doesn\u2019t absorb phenylephrine well enough to make it useful. Higher doses might work, but those doses would cause blood pressure to rise significantly.<\/p>\n

\u201cTherefore, in addition to lack of efficacy, there may be no path to evaluating higher doses of oral phenylephrine as a nasal decongestant,\u201d the FDA concluded.<\/p>\n

An industry group, the Consumer Healthcare Products Association (CHPA), argued against the FDA\u2019s position before the agency\u2019s panel.<\/p>\n

\u201cConsidering the data from multiple clinical trials demonstrating effectiveness and decades of in-market experience, CHPA urges the panel to recognize phenylephrine\u2019s clear benefits and critical role in public health,\u201d CHPA Vice President of Regulatory & Scientific Affairs Marcia Howard<\/a> said in a statement<\/a> to the committee.<\/p>\n

The CHPA also asked the panel to consider the potential impact on consumers.<\/p>\n

\u201cSimply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. health care system, which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications,\u201d Howard added.<\/p>\n

But Fox said doctors have already been shying away from recommending the products to patients.<\/p>\n

\u201cFor years, there has been the suggestion in the medical literature that phenylephrine lacks the efficacy of pseudoephedrine or oxymetazoline,\u201d Fox said. \u201cSo in my own practice, I have steered patients toward the latter two remedies.<\/p>\n

\u201cThe good news is that alternatives to phenylephrine are available on the market today,\u201d he added. \u201cFor symptoms of the common cold, pseudoephedrine and oxymetazoline nasal spray are effective.<\/p>\n

\u201cPseudoephedrine is subject to purchasing restrictions in most states; it is no longer on pharmacy shelves. However, it can typically be purchased from the pharmacist with a valid driver’s license,\u201d Fox noted. \u201cWhile this does pose a barrier, that barrier is not insurmountable and the restrictions do help to prevent the illicit diversion of pseudoephedrine toward the manufacture of methamphetamine.\u201d<\/p>\n

Fox added that patients also might want to try antihistamines rather than a decongestant, particularly if they have high blood pressure.<\/p>\n

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Sources<\/h2>\n