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cold medication
A Food and Drug Administration advisory panel agreed Tuesday that a common decongestant ingredient used in over-the-counter cold medications is ineffective.
The committee’s vote coincided with a possible decision by the agency to ban the key ingredient phenylephrine, which would disappear from hundreds of products.
Well, the F.D.A. In ordering its removal, a trade group warned that some popular products, including the cold and flu drugs Tylenol, Mucinex and Benadryl, could be seen as a race to reform by the companies.
Government officials often follow advisory board recommendations, but not always, and it can take months to make a final decision. And the consequences may be delayed in replacing the product or removing part of the stock from the stores.
panic or throw
In the meantime, experts have advised users to panic or throw away all the medicine. Although the company’s consultants found that taking the ingredient phenylephrine orally does not cause nasal congestion, it is not dangerous and the product contains other ingredients to relieve cold symptoms.
The panel’s vote on Monday and Tuesday came after a review of several existing studies, with consultants largely concluding that the research showed the drug was ineffective and better than a placebo.
Several consultants reported that patients receiving medication delayed access to supportive care.
“I think we have clearly better options in the prescribing area to help our patients and research has not confirmed that this drug is effective,” said committee chairwoman Maria Coyle. ” Associate Professor of Women and Pharmacy. The Ohio State University.
pharmacist at the University
“If you are constipated and you take this medicine, you will still be constipated,” says the doctor. McCullough. Leslie Handels, a pharmacist at the University of Florida in Gainesville, and colleagues submitted an application to the FDA. The drug was supposed to be taken off the market in 2007.
Millions of Americans are exposed to these drugs each flu and flu season, some for decades. More than 250 products with $1.8 billion in sales last year were affected by the parasite, according to agency filings.
There are two main over-the-counter medications: phenylephrine and pseudoephedrine.
According to the agency’s conservative standards, phenylephrine, which constricts blood vessels in the nose, has long been safe and effective, and the F.D.A. They still say it’s safe.
Nasal sprays with this material are still considered safe, even when used in surgery or to treat cataracts. Nasal sprays with another ingredient, oxymetazoline, can also fight nasal congestion.
Other antihistamines include oral pseudoephedrine with herbs or allergens, nasal sprays such as Flonase, and nasal sprays and oral pseudoephedrine.
Many popular cold and flu medications that do not specifically treat constipation do not contain this ingredient.
If the agency decides to pull the plug on the drug, it could seriously damage the cold medicine market if it doesn’t have enough time to develop a popular product.
It can even recycle the new, banned pseudoephedrine hidden behind stores that is often found in illegal meth labs.
Therefore, purchasing pseudoephedrine products can be a long and complicated process. Although a prescription is not required, they are kept away from pharmacists. The number of drugs that can be purchased at one time is limited and users must be at least 18 years old and have identification.
There are also side effects associated with pseudoephedrine, which can increase blood pressure and cause anxiety and depression. Handle (handle).
The matter goes forward with the FDA. accepted for decades
Current professor Dr. Handels said in an interview Tuesday that he has been thinking about art since 1993.
“The bottom line is that good research tells the real story about phenylephrine,” he said.
Potential benefits of using pesticides for workers include avoiding unnecessary costs or delaying treatment with “unnecessary pesticide exposure,” according to the agency.
Although there are no known health risks associated with taking cold medications containing phenylephrine, clients who are uncomfortable with one dose should not try different doses in the hope of short-term relief. Experts warn that large amounts of other substances can be dangerous.
The Healthcare Products Association, which represents companies that make over-the-counter drugs, released a statement Tuesday with the panel’s recommendations, saying the substance is safe and effective. Avoiding these items would have the “unintended negative effect” of referring patients to doctors and nurses for problems they may or may not be able to treat themselves, the association said.
“In short, limiting choice and access to these drugs will burden consumers and America’s already strained health care system,” said Marcia D. Howard. . Its articles
It may take some time for the change to be announced.
But the governor has already set a precedent by stating that its content is irrelevant. But now the F.D.A. The management will consider the comments and recommendations of its expert panel before preparing the final decision.
The FDA has acted. The agency can also give pharmacies a limited time to change product ingredients if necessary.
