In the past few hours, an advisory panel to the committee U.S. Food and Drug Administration (FDA) unanimously warns phenylephrineIs a common ingredient in over-the-counter treatments colds and allergies, It is not effective in its oral form.
the fact is, In Argentina, phenylephrine is present in different products designed to treat this condition. It is for this reason database Experts were consulted to learn about the situation within the country, What do regulatory disclosure requirements in North America mean?
as he advances databasean FDA panel unanimously voted that the oral drug Over-the-counter phenylephrine “They do nothing to relieve nasal congestion,” because in documents released by the North American entity, they state that “currently recommended doses of phenylephrine are not effective in patients with allergies.”
In this sense, they emphasize that “these new clinical and clinical pharmacology data are consistent, substantial and credible and confirm that oral phenylephrine is safe at any dose that can be developed to provide a reasonable margin of safety.” invalid.”
“We observed significant methodological and statistical issues with the design and conduct of the original studies presented and evaluated by the expert panel,” the North American experts stressed, while warning that problems with the drug may be related to the way the body absorbs it. Drug: phenylephrine. “Higher doses may be effective, but these doses can cause significant increases in blood pressure,” experts said.
Therefore, they concluded that “other than lack of efficacy, there may be no way to evaluate the efficacy of higher doses of oral phenylephrine as a nasal decongestant.”
The National Institutes of Health (NIH) states, “Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve congestion and sinus pressure.”
Likewise, it states that “phenylephrine can relieve symptoms, but it does not treat the cause of those symptoms or speed recovery. Phenylephrine belongs to a class of drugs called nasal decongestants. It works by narrowing the nasal passages Vascular inflammation.”
The drug has been on the market since the 1970s and is “administered orally as tablets, liquid, or soluble strips” “every 4 hours as needed.” National Institutes of Health. Likewise, there are other products such as nasal sprays that are not included in this analysis, as well as some combinations with other active ingredients.
“In Argentina, over-the-counter medicines containing phenylephrine are associated with other substances, such as analgesics (paracetamol, ibuprofen), butatelate (which has a cough suppressant effect) can be added, etc. It is recommended for common colds, that is, for the whole body Symptoms of discomfort, sometimes accompanied by fever and nasal congestion. For allergies, there are other over-the-counter molecules that are more recommended, such as: loratadine or cetirizine, etc.,” he said in the conversation Jimena Wassell Information, Medical Director, OTC Drug Association.
In my country, drugs containing phenylephrine as active ingredients include: anti-influenza acid, Brio-Grip, Vic Tea, Tabcin, Next, Gripaben and Benadryl, etc.
In this sense, when Infobae asked how effective the Argentinian drugs were, Vossell said: “The therapeutic effects of all these drugs are safe and effective.” At the same time, he clarified that “the FDA usually works with external expert groups, They analyze different issues and issue required reports; and from time to time, scientific information on molecules is reviewed,” he added.
“There has been a recent report questioning the dosage of phenylephrine used in over-the-counter and oral routes that may not be effective, and the FDA will analyze that information. But it is premature to question the effectiveness of this substance, as this analysis appears to still be It needs to be deepened,” he added.
“The first thing we can’t overlook is that medications are often called ‘flu drugs,’ basically because they don’t cure the flu but are designed to relieve flu symptoms. Flu is a disease caused by the influenza virus that we have Vaccines are designed to reduce the complications caused.” database Pulmonologist Gabriella Tabai (MN 107176), from Dr. Antonio A. Cetrángolo Chest Hospital.
as a clinician Ramiro Heredia (MN 117882), a member of the Emergency Department of the “José de San Martín” Hospital in the city of Buenos Aires, reported to database: “Colds are diseases caused by a variety of viruses. In this case, there is no specific treatment for these pathogens, so treatment is symptomatic relief. The same thing happens with allergies, which are the body’s overreaction to certain substances or elements that are harmless to most people. In both cases, what we are trying to do is reduce the symptoms. “
The pulmonologist emphasized in this tone that “these anti-influenza drugs do not act on the influenza virus, but reduce the symptoms of the disease. Although these associations are approved in our country and other countries, they are not absolutely harmless , but rather carry inherent risks like any other drug in that they may cause adverse reactions.”
“Research shows that these drugs have not been proven to work better than inactive drugs (placebos). What’s more, these drugs can also have side effects. While antibiotics can be used to fight bacterial infections, they have no effect on the viruses that cause colds. effects, and influenza viruses are not the only viruses associated with fever or influenza. Even other viruses can present symptoms such as colds, pharyngeal tonsillitis and bronchitis,” Tabai stressed.
In itself, Dr. Stella Maris Cuevas (MN: 81701), an otolaryngologist, olfactory specialist, and allergist, in database “There are a lot of antihistamines.” In this sense, he stressed, there are many over-the-counter drugs, although their “life” depends entirely on the ingredients and the number of milligrams, which is not clearly stated in the advertising.
Likewise, he emphasized that even when it comes to “droplets”, some “happen to damage mucous membranes and cause patients to suffer from gout.” because? Because the nose is clogged and clogged, “the blood vessels will immediately constrict to unblock it, but ultimately it creates a vicious cycle because the patient has to wear it more often over time.”
“In Argentina we use second or misnamed third generation antihistamines. The most famous and the first is loratadine. They are antihistamines or antiallergics and are called antihistamines for that reason. Histamine drugs because they inhibit the release of histamine. In this way, the release of histamine is inhibited and symptoms do not occur,” said the former president of the Association of Otolaryngology of Buenos Aires (AOCBA).
In this tone, Cuevas also highlighted the use of other classes of drugs, such as “the most commonly used loratadine and fexofenadine.” “Cetirizine is also used and is indicated for children under 2 years of age. It comes as oral drops, which is great because it replaces diphenhydramine (trade name) which is widely used by pediatricians. However. The toxic dose is very Close to therapeutic doses. This is why otolaryngologists and specialists do not use diphenhydramine.”
“If the expert points it out, he knows it. Because he knows the treatments he has. Currently, when allergies arise, a combination of antihistamines plus inhibitors of inflammatory mediators is used. The goal is that since allergy patients already have inflammation, we seek to slow down This process,” the expert emphasized.
On the other hand, regarding drugs used in the United States and also used in our country, Vossel emphasized, “We are not aware that Argentina or other reference regulatory agencies are conducting this analysis. For example, EMA, MHRA (UK), Canada.” At the same time “Even the report focuses on the oral route and does not include topical use (spray),” he clarified.