Active ingredients in common cold and cough medicines are being phased out due to concerns about their effectiveness.
Last month, the U.S. Food and Drug Administration proposed removing phenylephrine (the active ingredient in hundreds of over-the-counter drugs, including some versions of Tylenol, Benadryl, Nyquil, and Theraflu) from oral medications, stating that phenylephrine is not effective. He gave evidence that. Nasal decongestant.
“Based on our review of the available data and on the advice of our advisory committee, we are proceeding with the next steps in the process,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). Regarding the proposal.
Before the FDA’s proposal, several experts began to question its effectiveness. Leslie Hendeles and Randy Hutton, researchers at the University of Florida, petitioned the FDA in 2007 to reconsider the drug’s use. and See you in 2015.
Handeles and Hutton called for the removal of over-the-counter nasal decongestants from the market in 2015, following research led by Eli Meltzer, MD, of the Allergy and Asthma Medical Group and Research Center in San Diego. published in the same magazine.
The study, conducted over 7 days in 539 participants with seasonal allergic rhinitis, found that doses of phenylephrine between 10 and 40 milligrams did not produce significantly better results than placebo.
“It’s a good drug, but it’s not if you swallow it,” Hendeles said of the ingredients. “It cannot reach the nose because it is inactivated in the intestines and does not enter the bloodstream.”
According to an FDA releasethe agency has thoroughly reviewed all available data regarding the safety and effectiveness of oral phenylephrine. This includes both historical data used to support its effectiveness as a nasal decongestant 30 years ago, as well as recent clinical research on this ingredient.
The panel’s opinion of ineffectiveness applies only to oral phenylephrine, which generates annual sales of about $1.8 billion in the United States.
The drug is still considered effective as a nasal spray, but is used much less frequently.
Phenylephrine hasn’t always been the go-to ingredient in cold and allergy medicines.
Many products originally contained pseudoephedrine. but, A 2006 law banned over-the-counter sales of cold medicines containing the ingredient pseudoephedrine. This is because of concerns that it could be processed into methamphetamine.
What are some effective nasal decongestants?
Most over-the-counter nasal sprays and solutions are still considered effective.
Saline drops and rinses provide a quick solution for clearing mucus from the nose. For long-term relief from seasonal nasal congestion, itching, and sneezing, doctors often recommend nasal steroids such as Flonase, Nasacort, and Rhinocort.
Nasal steroids are usually most effective when used daily.
The future of oral phenylephrine
The process of removing oral phenylefurne drugs from the shelves can take years.
“The FDA has six months to accept comments on the proposal, including input from consumers and companies,” Associated Press health writer Matthew Perrone wrote. “The FDA must then consider feedback before making a final order. Even after that decision is final, companies will likely have a year or more to discontinue or reformulate the product.” .”
Associated Press material was used in this report.
