FDA To Pull Sudafed PE and Other Popular Cold Medicines Off Shelves Due to Ineffectiveness

The U.S. Food and Drug Administration (FDA) has proposed pulling some over-the-counter cold medicine across the country. Research has found that phenylephrine, an active ingredient in a number of cold and flu medicines, can be ineffective on children and adults when administered orally.

OTC cold medicines that may include phenylephrine include Advil Sinus Congestion & Pain, Sudafed PE, and some formulations of NyQuil. These medicines are a standard fixture in many American homes. However, last year an FDA panel unanimously concluded that phenylephrine was ineffective, laying the groundwork for this new proposal. It also led to some consumer lawsuits against pharmaceutical companies that manufacture OTC medicines with phenylephrine.

It's important to note that this order is due to ineffectiveness, not safety. The FDA panel found that there were no risks involved when drugs containing phenylephrine were used in recommended dosages. Longer-term use can lead to complications such as stomach bleeding, however.

Wait ... They're Taking My Sudafed?

Before you start stockpiling Sudafed (not that you could due to state and federal regulations) keep in mind that cold and flu medicines, even over-the-counter ones, can contain different ingredients. For example, Sudafed contains pseudoephedrine, which has been shown to be effective as a nasal decongestant. It is only Sudafed PE that contains phenylephrine. Advil has ibuprofen, an effective pain reliever. The FDA's proposal will not pull pseudoephedrine or ibuprofen from the shelves.

Unfortunately, pseudoephedrine has more serious side effects. It can also be used in making methamphetamine, which is why it is regulated at the state and federal level, and you generally can only buy limited amounts of it.

Still Have Options This Winter

If you disagree with the FDA and find phenylephrine effective, you will likely still have options this cold and flu season. The FDA has so far only issued a proposed order, not a final order. The FDA is currently accepting public comments on its proposed order. Because the removal of these medicines is due to ineffectiveness, not safety concerns, there is less urgency than in some other FDA orders.

Pharmaceutical companies that make OTC cold and flu medications will have some time to reformulate the compounds included in these drugs to ones that are FDA-approved. For now, however, it is likely that in the near future they will have to discontinue all production of the over-the-counter medicine with phenylephrine.

Related Resources:

• Lawsuit Over FDA Ivermectin Social Media Posts Settles (FindLaw's Courtside)
• Pharma Companies Agree to Ulcer-Inducing Settlement Over Zantac (FindLaw's Courtside)
• Consumer Reports Uncovers Lead in Lunchables (FindLaw's Law and Daily Life)