How to speak to your doctor about Post-Finasteride Syndrome, and why it’s important
Despite almost 20 years of self-reports, multiple case-controlled studies and warnings of side effects which can persist after stopping finasteride, Post-Finasteride Syndrome is still a poorly recognised and understood condition.
Due to a counter-intuitive clinical presentation, a lack of clear biomarkers, a general lack of awareness and inadequate regulatory action, clinicians are frequently perplexed that an apparently safe drug can cause such severe symptoms. Sadly, disbelief and skepticism are common reactions when men experiencing Post-Finasteride Syndrome seek clinical support.
When assessing this seemingly hostile and ineffective landscape, many patients feel a sense of futility regarding their participation. Why should they bother speaking to a doctor about Post-Finasteride Syndrome, when a potential outcome is outright dismissal? Consequently, many patients don’t speak to a healthcare professional. Others are unsure how to approach the conversation.
Other patients have more positive experiences when approaching their appointment with scientific backing and a clear plan. Each individual experience leads to an improved collective outcome, and patients should not underestimate the importance and potential benefits of speaking to their doctor about PFS.
In this article, we’ll provide a plan you can take to your appointment, and explain why it’s important to speak to your doctor about Post-Finasteride Syndrome.
Which doctor should you speak to
We highly recommend you speak to the doctor or company who prescribed finasteride. All medical professionals have a duty of care and are expected to report adverse reactions appropriately. If you are uncomfortable, we recommend you find an appointment with a specialist likely to be more aware of PFS. Such specialists include urologists, endocrinologists and andrologists.
Having the conversation
You should have clear objectives for the conversation. We recommend that you seek to have your case properly recorded and appropriately reported to your local regulatory authority. You should also have a clear framework to help you navigate the conversation. We recommend using the following steps as guidelines.
Print our cover letter. Before your appointment, download and print our cover letter and study abstract pack to bring to your appointment. If your appointment is online, request an email and send the letter prior to your appointment. This cover letter briefly explains PFS and provides key scientific literature.
Introduce the topic. Start by introducing the topic to your doctor. Share the cover letter and explain you are experiencing an adverse reaction which has persisted after stopping finasteride. Tell them you would like for your case to be appropriately recorded and reported to a regulatory agency. Do not attempt to explain the causes of PFS, or any of the science in detail. Do not attempt to assert how many men are affected.
Clearly explain your personal situation. Clearly outline the specifics of your case:
Explain the drug you took (e.g. finasteride, dutasteride, saw palmetto, other), at what dose, and for how long.
Explain the symptoms you experienced while on the drug.
Explain what happened when you stopped taking the drug. If you experienced a significant and sudden worsening, ensure this is recorded. If you experienced new symptoms after stopping finasteride, ensure they are recorded. It is important you thoroughly describe all of the symptoms you’ve experienced.
Provide a summary of your health prior to taking finasteride.
Allow time for discussion. Your doctor will have questions, so allow time for discussion. Remain calm, even if they express skepticism. If necessary, you can direct them to our science page for a complete overview of published scientific findings.
Confirm they are willing to report your reaction. After discussion, verbally confirm with your doctor that they will report your reaction to your local regulatory authority. It’s important to receive this verbal confirmation. It’s also important to ask that your symptoms be reported in their entirety.
If you are in the United States, ask to report your symptoms as “Post-5-alpha reductase inhibitor syndrome”. This is how the National Institutes of Health refers to Post-Finasteride Syndrome, and there is a specific reaction type in FAERS which can be selected. There are currently only 134 reports of Post-5-alpha reductase inhibitor syndrome in FAERS. We recommend patients who have already submitted a report submit a new one using this reaction type.
If your request is denied, move onto a specialist. There is no need to get into an argument if your doctor is unwilling to help. Simply end the appointment and move onto a specialist.
Ask if they would like to learn more. If they are, ask them to visit our website. Recommend they check out our explainer video, patient interviews, and science page.
Why you should speak to your doctor
There are three primary reasons to speak to a clinician about your adverse reaction: Regulatory action, awareness and recognition, and appropriate characterisation. All are equally important.
Regulatory action
A 2015 study by Dr Ayad Ali which investigated FAERS reports for finasteride concluded that persistent side effects had likely been underreported, particularly before the first PFS study was published in 2011. Adverse event reporting is an integral part of postmarketing surveillance and regulatory action.
While patients may be skeptical regulatory agencies’ ability to adequately address the safety risks associated with finasteride, that should not be an excuse for not participating in such a critical function. Many drugs are similarly approved after clinical trials before postmarketing surveillance indicates a significant problem.
A critical fact overlooked by many PFS patients is that regulatory reporting is a necessary signal which generates scientific interest. It is not just an instrument to ensure future consumers are aware of the drug’s significant risks.
Take Rofecoxib, sold under the brand name Vioxx, for example. Rofecoxib is a nonsteroidal anti-inflammatory drug which was infamously withdrawn from market in 2004 after being linked to heart attacks. There were more than 92,000 adverse event reports for rofecoxib submitted to US, European, UK, Canadian and Australian regulators in just over five years.
A search of Google Scholar for the term “rofecoxib myocardial infarction” between 1999-2004 reveals 1730 published scientific articles, including 449 literature reviews.
Finasteride is prescribed to less people, and it is not reasonable to assume there are 92,000 cases of PFS to report. The effects of rofecoxib were also more observable and immediately life-threatening. This article is not suggesting the two situations are directly comparable. Rofecoxib is, however, a powerful example that illustrates the influence large-scale adverse event reporting can have on generating scientific interest.
Similarly, regulatory action is necessary to increase clinical awareness. Many clinicians rely on drug warning labels and regulatory advice when prescribing drugs and responding to adverse reaction reports. If regulators are not providing sufficient warning signals, many clinicians will remain skeptical or unaware of PFS. That is why it is so important to request your adverse reaction is appropriately reported.
Clinical awareness
While specialised clinicians such as urologists, endocrinologists and andrologists are becoming aware of Post-Finasteride Syndrome, recognition is still poor. Although there is sufficient medical literature to indicate PFS is a problem, clinicians are largely unaware of it due to the condition’s rarity. With more exposure to men reporting persistent adverse effects, supported by findings from case-controlled studies and other literature, awareness and acceptance will increase.
Patients should also not underestimate the power of word of mouth. Many medical professionals establish networks with others in their field, and regularly discuss the latest news or relevant best practices. It is imperative that patients become more visible to clinicians to help create more conversation and awareness.
Appropriate characterisation
While symptoms such as anhedonia, muscle atrophy and difficulty concentrating are frequently reported by patients, they represent a combined total of 4% of reported reactions for finasteride in FAERS, the FDA’s adverse events reporting system. Conversely, erectile dysfunction, sexual dysfunction, depression, anxiety and low libido represent a combined total of 62%. This disparity is not reflected in the 20-year patient record.
The vast majority of media reports also mischaracterise Post-Finasteride Syndrome using these headline symptom categories.
In many severe cases, symptoms experienced go far beyond headline categories, and what is typically understood by these terms. That’s why it is important to have a detailed conversation, supported by scientific literature, to ensure the symptomatology of PFS is being thoroughly recorded.
Another reason accurate characterisation is crucial is so future scientific investigation is appropriately informed. Many hypotheses about the driving mechanisms involved in PFS are not connected to the clinical specifics or considerate of the complete symptom profile. It is crucial that the disease be more accurately characterised so that future investigation is appropriate and likely to generate meaningful insights.