Nasal decongestant phenylephrine, found in many over-the-counter cold and allergy medicines, doesn't work:
An independent advisory council to the US Food and Drug Administration decided on Tuesday that phenylephrine, a common component in many over-the-counter allergy and cold medications, is useless in tablet form.
The primary component of medications like Vicks Sinex, Sudafed PE, and Benadryl Allergy Plus Congestion is phenylephrine.
There was no disagreement that the component is regarded as safe for usage. But for years, many medical professionals have questioned the efficacy of phenylephrine. Data from the FDA was provided to the Nonprescription Drugs Advisory Committee on Monday at the committee's two-day meeting, showing that these items produced close to $1.8 billion in sales only last year.
Government specialists who evaluated the most recent data on the long-debated medicine component believe that the popular decongestant used by millions of Americans seeking relief from a stuffy nose is likely no better than a fake pill.
The FDA's advisory board overwhelmingly rejected the efficacy of the component in popular versions of Sudafed, Allegra, Dayquil, and other drugs available on drugstore shelves on Tuesday.
Dr. Mark Dykewicz, an allergy expert at the Saint Louis University School of Medicine, stated that "modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine."
Government specialists who evaluated the most recent data on the long-debated medicine component believe that the popular decongestant used by millions of Americans seeking relief from a stuffy nose is likely no better than a fake pill.
The FDA's advisory board overwhelmingly rejected the efficacy of the component in popular versions of Sudafed, Allegra, Dayquil, and other drugs available on drugstore shelves on Tuesday.
Dr. Mark Dykewicz, an allergy expert at the Saint Louis University School of Medicine, stated that "modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine."
Although the original formulations of Sudafed and other medications are still freely marketed, they only represent roughly one-fifth of the $2.2 billion global market for oral decongestants. The remaining is phenylephrine variants, which are occasionally marked "PE" on the packaging.
Johnson & Johnson, Bayer, and other pharmaceutical companies would be obliged to remove their oral drugs that contain phenylephrine from shop shelves if the FDA complies with the panel's recommendations. Customers would likely be forced to switch to the over-the-counter versions of the tablets or to phenylephrine-containing nasal sprays and drops, which are not currently being reviewed.
Although it did not provide a timeframe, the FDA assured the committee that it would take its recommendations into account. Stakeholders would have the chance to comment on the proposed modification and to offer any further data if the FDA chooses to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE). Businesses would still be able to promote items containing phenylephrine throughout that time. However, if the FDA concurs with the committee, businesses may be ordered to either reformulate or remove phenylephrine-containing items from shop shelves.
Phenylephrine was licensed for over-the-counter usage by the EPA in the 1970s, but its use increased after laws restricting access to OTC medications using the comparable decongestant chemical pseudoephedrine in 2005.
The FDA was petitioned to remove phenylephrine products based on recent studies indicating they did not perform better than placebo tablets in patients with cold and allergy congestion, prompting this week's two-day conference by researchers at the University of Florida. The FDA let the items to stay on the market while waiting for more studies despite the fact that the same researchers questioned the drug's efficacy in 2007.
At the time of a similar conference on medicine in 2007, the FDA's outside experts made the same recommendation.
This time, the FDA panel's 16 members unanimously concluded that the drug's potential benefits are not supported by the available data.
The American Academy of Allergy, Asthma, and Immunology states that phenylephrine is the most often found component in over-the-counter oral nose and sinus products. The organization sponsored a public petition to end the drug's classification as an over-the-counter medication last year.
The way phenylephrine works is by momentarily lessening the nasal blood vessel enlargement. Inflammation of the nasal membranes and the production of mucus are caused by the body sending white blood cells to the nose, throat, and sinuses in response to an infection or allergy. Decongestants reduce edema and aid in fluid drainage by constricting the blood arteries in the sinuses and nose.
