FDA considers putting an end to the use of a drug!
At the beginning of this month, the U.S. Food and Drug Administration (FDA) announced that it is proposing to stop permitting the over-the-counter (OTC) sale of none other than oral Sudafed PE. Phenylephrine, commonly sold as Sudafed PE, has for decades been promoted as an effective nasal decongestant. The FDA has now, however, after conducting what it describes as a “comprehensive review of all available data,” determined that phenylephrine is “not effective for this use” in oral form (although the nasal form is apparently effective). Meanwhile, no news on other best-selling drugs that themselves are believed by some to be neither safe nor effective.
It takes 30 years to discover a drug doesn't work?
The data concerned is not particularly extensive, consisting of only a few studies. Furthermore, as most people will be aware, phenylephrine has been around for decades and the FDA has therefore had access to “all available data” for decades. The FDA makes no secret of this, writing in its press release that,
The agency conducted a comprehensive review of all available data on the safety and efficacy of oral phenylephrine, including the historical data that were used to support the determination made 30 years ago that oral phenylephrine was effective as a nasal decongestant, as well as newer clinical data on oral phenylephrine that have since become available. [emphasis added]
The press release does not reveal the nature of the “newer clinical data.” According to drugs.com, however, concerns regarding the efficacy of phenylephrine were raised almost immediately after its submission to the FDA for approval, and professional recommendations received by the FDA urged the federal agency to refrain from authorizing the drug.
Drugs.com adds pertinent information that the FDA’s press release omits — namely, that the studies that supposedly showed the drug’s efficacy were conducted by the drug’s manufacturer:
... phenylephrine was approved by the FDA based on in-house studies provided by pharmaceutical companies, not as a result of clinical trials...
These unpublished studies ranged from mild successes to total failures.
Admittedly, this hardly sets phenylephrine apart as most if not all drugs submitted to the FDA for approval have been tested “in-house” and therefore the results are unreliable, especially when one takes into consideration the fact that only a select few of the trials conducted must be submitted to the FDA, the body making the selection being the drug manufacturer itself.
So it's 'safe and ineffective'! How reassuring...
The decision to review phenylephrine did not surprise many. In fact, the FDA’s Drug Advisory Committee already concluded over a year ago, in September of 2023, that the “current data do not support the effectiveness of phenylephrine as a nasal decongestant” in cold, cough, allergy, bronchodilator, or anti-asthmatic drug products.
Until a final decision is reached, products containing phenylephrine may continue to be sold. The FDA stresses that the drug’s safety is not in question and that the only reason they are considering withdrawing it is that it appears to be useless:
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
The FDA adds that there are plenty of safe and effective alternatives to phenylephrine, though it does not name them.
Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold...
In fact, there are not many effective drugs that ease congestion (although home remedies abound). The main pharmaceutical alternative is pseudoephedrine (Sudafed, without PE as part of its name), which drugs.com describes as far more effective than phenylephrine:
... phenylephrine is extensively metabolized in the gut wall. This means only about 40% of a dose reaches the bloodstream ... Pseudoephedrine is not metabolized in the gut wall, so almost 100% of a dose reaches the bloodstream.
Instead, use a drug that can 'make you feel like jumping out of your skin'
Nonetheless, there are several significant drawbacks to restricting the decongestant market to pseudoephedrine alone. Firstly, many states restrict the amount that may be purchased at one time due to concerns that it can be used to manufacture crystal meth. In fact, in some parts of the country, a driver’s license must be produced before purchase and the would-be consumer must submit to a criminal background check.
As one commenter on Medscape noted,
Saying there are plenty of alternatives to replace [phenylephrine] is a non sequitur. That list is very short at best, and by the time you add safe effective and acceptable there are zero alternatives. If you can get a pharmacy to sell pseudoephedrine they limit you to 10 tablets, and you have to undergo a background check and deal with every employee thinking that you are some sort of drug manufacturer.
This FDA panel is completely disconnected from the population and their common needs.
The government has already recognized that placing restrictions on the sale of pseudoephedrine has had no effect on meth consumption, but the restrictions remain.
However, the similarities between pseudoephedrine and meth are real, which is why some people respond badly to the drug, which causes them insomnia and “feeling like they want to jump out of their skin,” as another Medscape poster noted.
Explaining this phenomenon, drugs.com points out that pseudoephedrine has a “greater incidence of central nervous system (CNS) stimulant effects than phenylephrine,” because its chemical structure makes it far more likely than phenylephrine to cross into the brain.
Both phenylephrine and pseudoephedrine have 'drug ineffective' as main side-effect
Both the FDA and drugs.com consider both phenylephrine and pseudoephedrine to be largely safe, when taken in appropriate doses. That said, other sources such as WebMD describe “serious side effects” that may be associated with both drugs, including fast or irregular heartbeat, reduced blood flow to the extremities, severe shaking, seizures, mood changes (including panic and unusual thoughts and behavior), and trouble breathing.
Regarding dyspnea (trouble breathing), there are over 15,000 reports to the FDA related to phenylephrine. There are also almost 9,000 reports that mention “death” in connection with the use of the drug. Such reports (from OpenFDA) do not necessarily mean that the drug caused the adverse effect listed. Nonetheless, a significant number of reports is cause for concern and should prompt FDA investigation.
The number of serious side effects associated with pseudoephedrine in OpenFDA seems to be smaller than with phenylephrine. Top on the list of complaints for both drugs is “drug ineffective.” For phenylephrine, there have been 21,122 reports of inefficacy. For pseudoephedrine, the number is lower but far from insignificant, at 10,519 reports.
What about all the other drugs the FDA still likes?
Commenting on the FDA’s decision, Dr. Lumsden wondered aloud:
Let’s see how long it will take the FDA to realize the same [applies to] SSRI drugs.
Does the same apply? OpenFDA for Paxil, a commonly prescribed SSRI antidepressant, has “drug withdrawal syndrome” at the top of the list, which is a fairly useless term which could mean an almost infinite number of symptoms, ranging from the very serious and potentially life-threatening (such as akathisia) to the mild. “Drug ineffective” is third on the list, with 4,255 reports. Interestingly, “depression” is number eight on the list, and at number thirteen is “suicidal ideation.”
Other psychiatric drugs have similarly serious adverse effect profiles. Seroquel, for instance, a widely prescribed “antipsychotic,” is listed as “ineffective” by 8,502 people (top of the list). Number three on the list is “diabetes mellitus” and at number fourteen, with 5,313 reports, is “completed suicide.”
Meanwhile, Lipitor, one of the most widely prescribed statin drugs, has “drug ineffective” listed by 12,216 people, “diabetes mellitus” by 11,204 people, and “death” by in almost 7,000 cases.
Your chance to give the FDA a piece of your mind
The FDA is apparently not considering the withdrawal of any of the abovementioned drugs (which are just a few drops in the ocean of pharma products with serious adverse events associated with them). Nor is the FDA considering the withdrawal of the COVID shots despite the many thousands of serious side effects reported on VAERS, the federal reporting system for vaccines.
However, if members of the public wish to make their feelings known on the matter of whether to stop the sale of phenylephrine, they may also add comments on any relevant related issues on the online form provided here.
The FDA is seeking public comments on this proposed order. Instructions on how to submit comments are found in the proposed order available on OTC Monographs@FDA. If, after considering the comments, the FDA concludes oral phenylephrine is not effective as a nasal decongestant, the FDA will issue a final order removing oral phenylephrine from the OTC monograph, and drug products thereafter could no longer contain oral phenylephrine as a nasal decongestant. The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.
The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer or other qualified professional regarding any questions you may have about a medical condition, health objectives or legal or financial issues. If you are struggling with suicidal thoughts, call a qualified free mental health helpline or seek help from a qualified therapist.
