The FDA investigating common cold drugs: these "should never be used", warn doctors

The agency reassess the efficiency of phenylephrine, a widely used ingredient.


As we head towards the fall and winter seasons, many of us are preparing for the blocked nose and the irritated gorges. But before going to fill up on your cold drugs , you will want to be aware of the last US survey Food and Drug Administration (FDA). The regulatory agency now reassesses an ingredient widely used in some of the most popular over -the -counter aid (OTC), and doctors say that these cold drugs "should almost never be used". Read the rest to find out why all from Dayquil to Sudafed may soon be in trouble.

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Many cold cold drugs contain phenylephrine.

Aisle in a CVS pharmacy. CVS is the second largest pharmacy chain in the United States with more than 7,600 stores and ranked as the 13th largest company in the world
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If you have already suffered from a cold, allergies or hay colds, it is likely that you have taken phenylephrine. Used to relieve nasal discomfort, sinus congestion and pressure, this ingredient is in many different decongestants , both to itself and in combination with other drugs, according to the Medlineplus of the American National Library of Medicine.

Sudafed PE is the most recognizable brand for phenylephrine alone. But the ingredient is also used in combination with other symptoms in many current cold drugs.

According to Medlineplus, you can find the phenylephrine in advil congestion relief; Alka-Seltzer plus cold and cough formula; Benadryl-d Allergy more sinus; Choid mucicinex mucicinex mucicinex; Robitinssin Night Time Tix, colds and flu; Tylenol Cold Cold Multi-Symptom Nighttime; Vicks Dayquil Cold and flu -likeness; and Vicks Nyquil Sinex Nighttime Sinus Relief.

It should be noted that the active ingredient of Sudafed - the kind pharmacists stand behind the counter, without the "PE" in its name - is pseudoephedrine, a proven decongestionary. Medicines with pseudoephedrine are not examined by the FDA.

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The FDA is currently investigating this ingredient.

Selective focus view of Sudafed Sinus and Pain Relief medicine on the shelves at local pharmacy. Sinus congestion and pressure, headaches medication. Winter cold.
Dropout

Phenylephrine was approved for the first time by the FDA for free use in the 1970s, according to NBC News. But now, the agency's without prescription advisory committee (NDAC) is reassessed the effectiveness of the medication.

The two days advisory meeting Started yesterday, September 11, and the Committee discusses new data concerning the status "generally recognized as safe and effective" (grase) of oral phenylephrine as a nasal decongestant, according to a briefing Published by the FDA.

After examining the available data, the NDAC will vote if they believe that the evidence shows that oral phenylephrine is effective or not. If the panel of external advisers determines that the ingredient is ineffective, the FDA will then have to decide if it should be reclassified as not to climb.

Experts have long declared that phenylephrine was ineffective.

Sick young woman headache fever cough cold sneezing sitting under the blanket on sofa in living room at home.
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Concerns concerning Phenylephrine efficiency Return to 2007, according to CBS News. At that time, pharmacy teachers Leslie Hendeles And Randy Hatton Placed a petition to have the medicine from stores withdrawn, as evidence indicated that it was no more efficient than a placebo.

As NBC News also explained, pharmacists have cited studies that have indicated that phenylephrine is metabolized in a way that only a small part of the drug really reaches the nose in order to relieve congestion.

The FDA chose not to revoke the state of the grace of the drug in 2007, but Hendeles and Hatton submitted a new petition In 2015, the agency's request again pulled the medication. Experts have cited new data, adding to their statements that phenylephrine is "useless" to reach blood circulation thanks to these ORAL OTC drugs, CBS News reported.

"When you take it orally, it goes to the intestine. And as it is absorbed by the intestine, there are two enzymes which metabolize it in such a large extent that a very tiny quantity goes to the blood circulation" said Hatton Nouvelles.

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Some doctors think it should never be used.

Sick ill man looking for medicines at pharmacy shelf
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Hendeles and Hatton are not the only ones who repel against oral phenylephrine. Purevi Parikh , MD, allerchist and immunologist at Allergy & Asthma Associates of Murray Hill in New York, told NBC News That the drug "should almost never be used" because it is ineffective. AE0FCC31AE342FD3A1346EBB1F342FCB

"Sudafed works for a few days, but not in the long term," said Parikh.

Wynne Armand A primary care doctor at Massachusetts General Hospital told CBS News that she did not recommend his use for the same reason.

"When my patients ask for over-the-counter drugs for cold symptoms, I tell them to avoid buying oral drugs that have phenylephrine," she said.

According to Armand, allowing people to use drugs containing oral phenylephrine is not only worrying because they do not work. These drugs are also harmful because drugs can cause side effects such as headaches, insomnia and nervousness.

Some cold drugs could end up being more difficult to obtain.

3 bottle pack of DayQuil and NyQuil by Vicks. Severy Cold and Flu relief. Acetamenaphine as active medicinal ingredient.
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In a separate NDAC briefing Published a few days before the meeting, the FDA acknowledged that it had already changed its position of the effectiveness of oral phenylephrine. The agency continued to reassess scientific support to the drug since the 2007 meeting, and said that it had now reached the conclusion that it is "not effective as a nasal decongestant" at the standard dose of 10 milligrams every four hours, or even in higher doses up to 40 milligrams every four hours.

If the NDAC votes to agree that it is ineffective, the FDA can decide to revoke the state of the phenylephrine fat. The agency is not required To follow the advice of independent advisory committees, but it generally does, according to Axios. A lack of state of the bass would make more difficult for manufacturers to include phenylephrine in over -the -counter products, and could lead to drugs such as Sudafed, cold and daycil influenza, and the cold Tylenol being drawn from Store shelves.

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