The drug will remain on the shelf, despite the results that it does not work
The drug will remain on the shelf, despite the results that it does not work
The world has gone crazy, or maybe just the doctors. Every doctor knows that every medication has side effects. Basic professional ethics requires doctors to balance the expected benefits of a drug against the risks of side effects. The simple question is: Is this drug likely to do more good than harm? If yes, alert the patient to the risks and prescribe the medication. If the answer is no, find another way to treat the patient.
What is the outcome when research finds that a drug does not have the beneficial effect indicated by previous studies? Simply put: the medicine on the market that does not help in treatment exposes the patient to side effects (harm) without benefit.
Why would anyone take - or prescribe - a medication that doesn't work and could be harmful? But that's exactly what the Food and Drug Administration (FDA) is discussing now.
Thanks to the stubborn persistence of Randy C. Hatton and Leslie Handels, the FDA finally put multiple studies before an FDA advisory committee that unanimously agreed that the evidence shows that the active ingredient in the over-the-counter drug Sudafed PE does not. It does not relieve sinus pain or congestion when taken orally. This ingredient, phenylephrine, is also found in many combination medications such as Benadryl Allergy Plus Congestion and PediaCare Children’s Decongestant.
Sudafed vs Sudafed PE, what's the difference?
Will Sudafed PE be taken off the market?
Nervousness, dizziness and insomnia are not a safety issue, according to the FDA
What can I do to relieve congestion?
What PE medications work for nasal congestion?
Why can I get Sudafed PE right off the shelves and for the "real" Sudafed I have to go to the counter?
Sudafed vs Sudafed PE, what's the difference?
The similarity between the two names creates confusion. Sudafed (no PE after the name) is an effective decongestant medication but there are restrictions on getting it. You do not need a prescription, but you must request it from the pharmacy and show your ID. The main ingredient of Sudafed is pseudoephedrine and it is very effective in clearing congestion. Unfortunately, it can also be turned into methamphetamine in a home lab (which means an amateur scientist wouldn't have much trouble turning it into an addictive and dangerous drug).
When the FDA moved Sudafed behind the pharmacy, the drug company quickly launched a new and different decongestant, phenylephrine, using an almost identical name, Sudafed PE. In this apparent “bait and switch,” the drug company used the same name (with the addition of two insignificant-sounding initials) to sell a different, ineffective drug. This medication is on the shelf with all other cold and flu treatments. Its main ingredient, phenylephrine, is now used in many cold and flu treatments.
Will Sudafed PE be taken off the market?
Since phenylephrine doesn't work, we can expect the FDA to step in to tell doctors to stop recommending it, and Sudafed PE has been removed from pharmacies, making sure it's removed from multi-ingredient cold and flu medications, right?
Although the research was conclusive, the FDA has called a meeting of its Over-the-Counter Drug Advisory Committee in September 2023 to discuss what to do with the new information about Sudafed. Advisory committees are typically called when the FDA finds that data are unclear or when it is difficult to evaluate the risk/benefit balance of a drug. Meetings are held to review research, have an open discussion, and provide opinions on what the FDA should do. Advisory committees are overwhelmingly composed of physicians, researchers, pharmacists, sometimes a patient representative, always an industry representative and always a consumer representative. (Disclosure, I am an appointed consumer representative on the FDA's Drug Safety and Risk Management Committee.)
Good job by the consumer representative on the panel, who spoke.
“I feel that this drug, at this oral dose, should have been removed from the market a long time ago,” said Jennifer Schwartzott, a patient representative on the committee. "Patients need and deserve medications that treat their symptoms safely and effectively, and I don't believe this medication does that."
Nervousness, dizziness and insomnia are not a safety issue, according to the FDA
Shockingly, the FDA is now “considering” removing phenylephrine from the GRASE, generally accepted as a safe and effective list of medications. Why?
The US Food and Drug Administration (FDA) issued a press release assuring the public that it is safe to continue using products containing phenylephrine.
But side effects of phenylephrine include nervousness, dizziness, and insomnia. Yes, none of them are likely to cause long-term harm, but they can definitely intrude on your day and make you feel sicker than you did before you took the medication. Not everyone can stay at home in bed when they are crowded. If you need to drive a car or take care of young children, the dizziness, nervousness and fatigue caused by insomnia is definitely a safety issue.
