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FDA Panel Says Common Over-The-Counter Decongestant Does Not Work.
Consumers who purchased various OTC Decongestants May Be Entitled To Compensation, Including:
- Sudafed® Sinus Congestion
- Tylenol® Cold & Flu Severe
- NyQuil® Severe Cold & Flu
- Theraflu® Severe Cold Relief
- Mucinex® Sinus Max
- Dayquil® Cold & Flu
- Robitussin® Peak Cold Nighttime Nasal Relief
- Sudafed® PE Sinus Congestion
- Theraflu®
- Generic Walmart, Walgreens/CVS Brands
FDA Advisory Panel Verdict Could Shock The OTC Cold & Allergy Medication Market.
In a unanimous decision, a Food and Drug Administration (FDA) advisory panel issued a verdict that could send shockwaves through the over-the-counter (OTC) cold and allergy medication market.
The panel declared that phenylephrine, a key component in numerous OTC cold and allergy remedies, is ineffective in alleviating nasal congestion.
This pronouncement primarily applies to oral forms of phenylephrine and is expected to disrupt a market where consumers predominantly favor pills over nasal sprays.
According to FDA data, Phenylephrine:
- Holds the distinction of being the most widely used oral decongestant in the US;
- Contributes nearly $1.8 billion in sales from year to year;
- Is marketed to reduce nasal congestion by decreasing the swelling of blood vessels in the nasal passages.
However, the advisory panel's vote was supported by damning evidence presented by the FDA, which indicated that when phenylephrine is taken orally, only a minimal amount of the drug reaches the nasal passages to relieve congestion.
The FDA now decides whether to revoke phenylephrine's OTC designation as "generally recognized as safe and effective."
Typically granted to older drugs, this designation permits their inclusion in OTC products without requiring a complete FDA application.
Should the FDA withdraw this designation, phenylephrine products may be removed from store shelves, and manufacturers might need to develop alternative formulations.
More History On The Growth & Surge Of Phenylephrine
Phenylephrine gained popularity in the early 2000s as a substitute for pseudoephedrine, the decongestant formerly used in Sudafed®.
Pseudoephedrine was moved behind pharmacy counters in 2006 to deter its misuse in the production of methamphetamine.
During the two-day FDA meeting, scientists presented the findings of five studies conducted over the past two decades, concluding that oral phenylephrine was no more effective than a placebo.
The FDA also revisited the initial data to support the OTC use of phenylephrine, revealing inconsistencies and issues related to study design and data integrity.
Beyond its ineffectiveness, phenylephrine can induce side effects such as:
- Headaches;
- Insomnia;
- Nervousness;
- Higher doses can elevate blood pressure.
Notably, the advisory panel did not question the effectiveness of phenylephrine in nasal spray form, which is still considered to provide temporary relief from congestion.
Representatives of the Consumer Healthcare Products Association, a group representing OTC drug manufacturers:
- Argued that removing oral phenylephrine from OTC availability would pose a significant burden to consumers;
- Shared the results of a survey indicating that half of U.S. households used an oral decongestant in the past year;
- Revealed that people favored oral decongestants over nasal sprays at a ratio of 3 to 1;
- Argued that other effective alternatives would not be as accessible, a claim disputed by advisory committee members.
The FDA has not provided a timeline for its final decision, but historically, it tends to align with the recommendations of its advisory committees.
Eligible consumers are encouraged to request a free, private case evaluation by our experienced legal staff with the potential for compensation and justice.
Find Out if You Qualify
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FDA Advisory Panel Verdict Could Shock The OTC Cold & Allergy Medication Market.
In a unanimous decision, a Food and Drug Administration (FDA) advisory panel issued a verdict that could send shockwaves through the over-the-counter (OTC) cold and allergy medication market.
The panel declared that phenylephrine, a key component in numerous OTC cold and allergy remedies, is ineffective in alleviating nasal congestion.
This pronouncement primarily applies to oral forms of phenylephrine and is expected to disrupt a market where consumers predominantly favor pills over nasal sprays.
According to FDA data, Phenylephrine:
- Holds the distinction of being the most widely used oral decongestant in the US;
- Contributes nearly $1.8 billion in sales from year to year;
- Is marketed to reduce nasal congestion by decreasing the swelling of blood vessels in the nasal passages.
However, the advisory panel's vote was supported by damning evidence presented by the FDA, which indicated that when phenylephrine is taken orally, only a minimal amount of the drug reaches the nasal passages to relieve congestion.
The FDA now decides whether to revoke phenylephrine's OTC designation as "generally recognized as safe and effective."
Typically granted to older drugs, this designation permits their inclusion in OTC products without requiring a complete FDA application.
Should the FDA withdraw this designation, phenylephrine products may be removed from store shelves, and manufacturers might need to develop alternative formulations.
More History On The Growth & Surge Of Phenylephrine
Phenylephrine gained popularity in the early 2000s as a substitute for pseudoephedrine, the decongestant formerly used in Sudafed®.
Pseudoephedrine was moved behind pharmacy counters in 2006 to deter its misuse in the production of methamphetamine.
During the two-day FDA meeting, scientists presented the findings of five studies conducted over the past two decades, concluding that oral phenylephrine was no more effective than a placebo.
The FDA also revisited the initial data to support the OTC use of phenylephrine, revealing inconsistencies and issues related to study design and data integrity.
Beyond its ineffectiveness, phenylephrine can induce side effects such as:
- Headaches;
- Insomnia;
- Nervousness;
- Higher doses can elevate blood pressure.
Notably, the advisory panel did not question the effectiveness of phenylephrine in nasal spray form, which is still considered to provide temporary relief from congestion.
Representatives of the Consumer Healthcare Products Association, a group representing OTC drug manufacturers:
- Argued that removing oral phenylephrine from OTC availability would pose a significant burden to consumers;
- Shared the results of a survey indicating that half of U.S. households used an oral decongestant in the past year;
- Revealed that people favored oral decongestants over nasal sprays at a ratio of 3 to 1;
- Argued that other effective alternatives would not be as accessible, a claim disputed by advisory committee members.
The FDA has not provided a timeline for its final decision, but historically, it tends to align with the recommendations of its advisory committees.
Eligible consumers are encouraged to request a free, private case evaluation by our experienced legal staff with the potential for compensation and justice.
100% Free & Secure Case Evaluations
If you’ve purchased products containing the drug phenylephrine, you may be eligible for compensation—we fight for justice!
Victims of mismarketed products should have every opportunity to address the manufacturers in court and get the compensation and justice they deserve.
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