Phenylephrine investigation – Top Class Actions

Phenylephrine: Who’s affected?

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Have you purchased an over-the-counter cough and cold medicine with phenylephrine as an active ingredient?

Stuffy noses are uncomfortable, and we all want to be back to normal as soon as possible. Unfortunately, an advisory committee for the U.S. Food and Drug Administration recently voted unanimously against using the drug phenylephrine as an oral medication to cure nasal congestion. The Non-prescription Drug Advisory Committee voted against continuing to call oral phenylephrine safe and effective against nasal congestion. To be clear, the drug is still considered safe, it’s just not considered effective.

Studies have shown the medicine doesn’t work in pill form, so the 16-member panel looked at those studies and agreed, saying that companies shouldn’t be able to claim that medicines using the drug can help resolve nasal congestion when customers follow the recommended dosage on the back of the bottle.

The advisory committee comprises doctors and pharmacists who provide independent advice to the FDA before it makes decisions on which drugs to recommend or not recommend.

Do you qualify?

If you purchased an over-the-counter cough or cold medicine that contained phenylephrine as the active ingredient, you could be eligible to join a class action lawsuit investigation

Please fill out the form on this page for more information.

Have you purchased cough and cold medicine that includes phenylephrine?

Oral phenylephrine is found in many over-the-counter cough and cold medications. If you purchased any of those medications, you’ve likely purchased phenylephrine in a medication that claims it can help with nasal decongestion.

Those medications, however, can include a lot of other drugs, such as acetaminophen and ibuprofen. Therefore, consumers can’t just rely on the name or the large print to find out if a medication contains phenylephrine — they have to closely examine the active ingredient labels.

The problem, according to the advisory committee, is labeling and claims that say phenylephrine is effective. Industry leaders still want customers to believe that, but the FDA advisory committee hopes its recommendation will jumpstart the process of ending the “safe and effective” FDA recommendation.

Phenylephrine could lose GRAS tag

At issue is an OTC monograph on over-the-counter medications — essentially words and recommendations stating a drug is Generally Recognized As Safe (GRAS).

That GRAS designation indicates medications sold at drug stores or used by consumers for particular issues — in this case for nasal congestion — have been adequately shown to be safe under the conditions of the drug’s intended use. Without a GRAS designation, products containing phenylephrine are no longer considered effective.

If the FDA decides to start the process of removing the GRAS tag, it will first issue a proposed order to remove it. Then the FDA will receive public comments on the order. After considering those comments, the FDA will decide if it still plans to move forward with the monograph removal.

At that point, the FDA can issue a final order, and the OTC monograph would be removed for phenylephrine. This would mean that common medicines containing phenylephrine would be removed from shelves while manufacturers reformulated them. Having this happen at the start of cold and flu season could be disruptive.

Recommendation doesn’t impact nasal spray

The oral phenylephrine recommendation from the independent committee only affects tablets, capsules and liquids containing the drug. The FDA says nasal sprays designed to treat decongestion are not affected by the committee’s recommendation.

The FDA said the process is a part of how the organization actively works to ensure that medications available to the general public remain both safe and effective based on their recommended dosages.

Join a phenylephrine class action lawsuit investigation

Oral phenylephrine has been sold for years as an effective over-the-counter drug acting as a nasal decongestant in cough and cold medicines.

But an advisory committee for the FDA recently voted unanimously to state that the drug is not effective in the recommended doses in those medicines.

The FDA may use that advice to ultimately take action on its recommendation of drugs for sale to consumers.

If you purchased an over-the-counter cough and cold medication containing phenylephrine, you may qualify to participate in the phenylephrine lawsuit investigation.

Please fill out the form on this page to see if you qualify for a FREE case evaluation.

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