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The U.S. Food and Drug Administration is reevaluating its effectiveness. Phenylephrinea drug found in many over-the-counter medicine products to treat nasal and sinus congestion.
in hearing On Monday and Tuesday, expert members of the FDA’s OTC Advisory Committee are discussing the pill drug used in popular products such as Benadryl Allergy Plus Congestion, Sudafed PE, and Vicks Sinex. Phenylephrine is also used in some liquid and spray nasal decongestants, but that form is not part of this review.
According to the American College of Allergy, Asthma, and Immunology, phenylephrine is considered the most common ingredient in over-the-counter oral nasal and sinus products. Last year, our group supported: A public petition calling for the over-the-counter status of this drug to be removed.
Phenylephrine works by temporarily reducing the swelling of blood vessels in the nasal passages. Respiratory infections and allergies cause the body to send white blood cells into the nose, throat, and sinuses, causing swelling of the nasal mucous membranes and mucus production. Decongestants constrict blood vessels in the sinuses and nose, reducing swelling and helping fluid drain.
According to some scientists, phenylephrine is absorbed from the intestines in pill form and metabolized so well that only a small amount reaches the bloodstream, where it is needed to reach the nose. citizen petition It requires the FDA to remove the drug from store shelves.a citizen petition It is a way for industry, consumer groups, and individuals to petition the FDA for regulatory changes or other administrative actions.
In a briefing prepared for this week’s FDA committee meeting, agency reviewers said that after reviewing the evidence, “we have now reached the initial conclusion that PE was administered orally.” said. [phenylephrine] It is ineffective as a nasal decongestant even at the monograph-listed doses (PE hydrochloride 10 mg given every 4 hours) and up to 40 mg (given every 4 hours). ”
If an FDA panel votes that the ingredient is not useful as a nasal decongestant, the agency could decide to reclassify the ingredient, which is currently under consideration. “Generally Recognized as Safe and Effective,” or GRASE.
Once an ingredient is declared GRASE, pharmaceutical companies can add it to their products without going through the FDA approval process. If the FDA reclassifies phenylephrine, the ingredient will still be available; Many over-the-counter tablets that use this ingredient may need to be taken off the shelf or reformulated.
Phenylephrine was approved for over-the-counter use by the FDA in the 1970s, but has become more common since 2005, when legislation restricted access to over-the-counter medications that use a similar decongestant ingredient called pseudoephedrine. I did.
Medications containing pseudoephedrine were still considered to be sold over the counter, but because large quantities of pseudoephedrine could be used to make the illegal drug methamphetamine, they were now kept behind the counter in pharmacies. I did. Phenylephrine cannot be used to make stimulants.
Many doctors have long questioned the effectiveness of phenylephrine. The same FDA committee, which met this week, delved into the 2007 science, including a meta-analysis that found the ingredient “may be effective.”The committee called for further research, including on the drug’s effectiveness at higher doses. than the standard 10-40 milligrams. However, doses of 80 to 90 milligrams appear to increase blood pressure, according to an FDA briefing document.
Since the 2007 hearing, three large clinical trials have shown that the orally administered ingredient is not effective as a decongestant at typical doses, according to an FDA briefing.
2015Professor, College of Pharmacy, University of Florida Doctors. Leslie Henderes and Randy C. Hutton filed a national petition asking the FDA to remove the GRASE designation for oral phenylephrine. They also filed the petition that led to the 2007 hearing.
Redesignating phenylephrine could be costly for manufacturers. The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter drugs, dietary supplements and consumer medical devices, opposes the change. The group says it is urging the FDA committee to “recognize the clear benefits and important role of PE in public health.”
The FDA committee’s briefing document seeks to educate the public about this decision because so many people could see their favorite nasal decongestants disappear from store shelves if the designation changes. It points out that a concerted effort will be needed to achieve this goal.
Dr. Zara Patel, director of endoscopic skull base surgery and professor of otorhinolaryngology at Stanford University, said the public could be confused if the product suddenly became unavailable in stores. But she says that shouldn’t be seen as a reason to distrust regulators.
“This is how science works. As more information becomes available, recommendations may change, and that’s not a bad thing. That’s the great thing about science. We take advantage of new information. “You can change your perspective,” said Patel, who is not on the FDA committee.
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She hopes that if the FDA takes action, people won’t have to worry that the drugs they’ve been taking for years aren’t actually safe. “The opposite is the case. In fact, the doses contained in these drugs are ineffective,” Patel said. “We don’t want people to take something that has no benefit.”
It is also important to note that the committee has not investigated the effectiveness of sprays using phenylephrine. They can be effective in a very short period of time, says Dr. Brian Danza, a physician at University Hospitals Health System in Cleveland who specializes in sinus and endoscopic skull base surgery.
“In our clinic, we use this as a way to unclog noses in a very short period of time, allowing us to see inside the nose better. It also helps stop nosebleeds during surgery. It may also be used for Danzais not a member of any FDA committee.
However, the ingredients in the spray version only work for a short time (usually 60 to 90 minutes), after which the effects may wear off. It is also addictive and can damage nasal tissues with long-term use.
