WASHINGTON — The leading decongestant utilized by millions of Americans looking for relief from a stuffy nose is no muchbetter than a dummy tablet, according to federalgovernment specialists who examined the mostcurrent researchstudy on the long-questioned drug component.
Advisers to the Food and Drug Administration voted all on Tuesday versus the efficiency of the secret drug discovered in popular variations of Sudafed, Dayquil and other medications equipped on shop racks.
“Modern researchstudies, when well performed, are not revealing any enhancement in blockage with phenylephrine,” stated Dr. Mark Dykewicz, an allergicreaction expert at the Saint Louis University School of Medicine.
The FDA puttogether its outside consultants to take another appearance at phenylephrine, which endedupbeing the primary drug in overthecounter decongestants when medications with an older activeingredient — pseudoephedrine — were moved behind drugstore counters. A 2006 law had required the relocation duetothefactthat pseudoephedrine can be unlawfully processed into methamphetamine.
Those initial variations of Sudafed and other medications stay readilyavailable without a prescription, however they’re less popular and account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine variations — often identified “PE” on productpackaging — make up the rest.
If the FDA follows through on the panel’s suggestions, Johnson & Johnson, Bayer and other drugmakers might be needed to pull their oral medications consistingof phenylephrine from shop racks. That would mostlikely force customers to switch to the behind-the-counter pseudoephedrine items or to phenylephrine-based nasal sprays and drops.
In that situation, the FDA would have to work with pharmacies, pharmacists and other health serviceproviders to inform customers about the staying alternatives for dealingwith blockage, panelists stated Tuesday.
The group likewise informed the FDA that studying phenylephrine at greater dosages was not an alternative since it can push blood pressure to possibly unsafe levels.
“I think there’s a security concern there,” stated Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think this is a done offer as far as I’m worried. It doesn’t work.”
This week’s two-day conference was triggered by University of Florida scientists who