2023-09-15 01:53:04
Through a statement, the Food and Drug Administration (FDA) declared ineffective a popular drug used by millions of people against cold symptoms; Specialists describe that it has not been proven to be more effective than a placebo.
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What medication was declared ineffective by the FDA?
The phenilefrina in tablets is the active ingredient that the FDA declared ineffective, a component used in various over the counter drugs to combat the nasal congestion, one of the main symptoms of colds and allergies. However, the verdict issued by an independent FDA advisory committee has caused a stir because the substance was considered safe.
According to data provided by the FDA, the phenilefrina It is found in medications such as Sudafed PE, Vicks Sinex y Benadryl Allergy Plus Congestionsome of the decongestants most popular in the United States, generating around $1.8 billion in sales last year.
What is phenylephrine and what is it for?
The phenilefrina it’s a vasoconstrictor medication which is used as nasal decongestant to relieve discomfort caused by colds, allergies or hay fever. According to the United States National Library of Medicine, Its main function is to narrow the blood vessels in the nasal mucosa, thus relieving congestion.
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Although it is located in over the counter productssuch as tablets, nasal sprays and drops, should be used with caution as directed, as excessive or prolonged use may have side effects unwanted, such as rebound reaction or increased blood pressure.
Why doesn’t phenylephrine work against nasal congestion?
According to some experts, when taken in pill form, the phenilefrina It is absorbed in the intestine and metabolized efficiently, so that only a small amount enters the bloodstream, where it is necessary for its effectiveness in nasal treatment.
This information comes from a petition made by citizens urging the FDA to remove the drug from store shelves. A citizen petition is a mechanism through which industry, consumer groups, or individuals can ask the FDA to change regulations or take other administrative actions.
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“It’s surprising how many dollars are spent on something that really has no efficacy,” said committee member Dr. William Fig, a clinical pharmacologist and researcher at the National Cancer Institute.
The data presented by the FDA, shared last Tuesday, is the result of five studies on the effectiveness of oral phenylephrine, carried out during the last years, of which all concluded that the decongestant It is no more effective than a placebo.
So far, it has not been reported whether the FDA has required companies to withdraw their phenylephrine medications from the market until they reformulate their drugs.
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