FDA Panel Says Common Over-The-Counter Decongestant Does Not Work.
Consumers who purchased various OTC Decongestants May Be Entitled To Compensation
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.
Phenylephrine Is Ineffective In Alleviating Nasal Congestion
If you’ve purchased products containing the drug phenylephrine, you may be eligible for compensation—we fight for justice!
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Phenylephrine Info To Prepare Consumers
What is the history of Phenylephrine on the market?
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.
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
Other products containing Phenylephrine include:
Dayquil® Cold & Flu
Robitussin® Peak Cold Nighttime Nasal Relief
Sudafed® PE Sinus Congestion
Theraflu®
Generic Walmart, Walgreens/CVS Brands
Compensation Begins With A Free Online Case Review
Eligible consumers are encouraged to request a free, private case evaluation by our experienced legal staff with the potential for compensation and justice.
Phenylephrine FAQ: Questions About Phenylephrine
What were the FDA’s findings?
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.
How did this mistake with phenylephrine happen?
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.
Does phenylephrine have any side effects?
Beyond its ineffectiveness, phenylephrine can induce side effects such as:
- Headaches;
- Insomnia;
- Nervousness;
- Higher doses can elevate blood pressure.
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Our attorneys have a track record of getting answers to serious questions, communicating with government officials, and completing your case promptly.
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