पीएफएस ग्लोबल चेतावनी मैप

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation

Cases of depression and, more rarely, suicidal ideation have been observed in men treated with finasteride 1 mg for hair loss. The risk of depression is also associated with finasteride… Patients and healthcare professionals are advised that any change in mood should lead to treatment discontinuation.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation

[T]here is the possibility that finasteride use may result in Post Finasteride Syndrome... [D]own scheduling finasteride to Schedule 3 would set a dangerous precedent for Category X medications, and the potential risks from broader access under Schedule 3 significantly outweigh the benefits.

[D]epression (feelings of severe sadness and unworthiness) including suicidal thoughts. These are uncommon side effects that have been reported with [finasteride].

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

In patients treated with [finasteride], mood changes such as depressed mood, depression and, less commonly, suicidal thoughts were reported. If you notice any of these symptoms, consult your doctor immediately.

Mood changes and depression: In patients treated with Sandoz finasteride, mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts… Side effects can occur [including] inability to get an erection that persists after stopping treatment, decreased sexual drive that persists after stopping treatment.

• loss of libido
• sexual dysfunction
• depression

The following side effects have been reported with post-marketing use of finasteride: Hypersensitivity reactions, pruritus, edema of the face and lips, pain in the testicles, palpitations, elevated liver enzymes, depression. In some individuals…these symptoms were persistent.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

[D]epressed mood, depression and, less commonly, suicidal thoughts have been reported in patients taking finasteride. Patients should be evaluated for psychiatric disorders and, if they occur, the patient should seek medical help… Reproductive system and breast disorders [include] sexual dysfunction that may persist after treatment is stopped.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

New data, analyzed by the European Medicines Agency, has concluded that the risks of mood disorders, suicidal ideation and depression are possible while taking finasteride at 1 mg/day… Treatment with finasteride should be discontinued in the event of any psychiatric symptoms. It is important that patients are informed of these risks, since no leaflet accompanies the custom prescriptions [i.e., those prepared by pharmacists per doctors' specifications] of finasteride at 1mg.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

[F]inasteride, when applied topically, has systemic absorption, thus leading to the same side effects when used orally. [The Technical Advisory Committee on Cosmetics] recommends: Prohibit the use of finasteride in cosmetic products.

Patients should also be aware of the risk of sexual dysfunction...during treatment with finasteride. Patients should also be informed that, based on individual patient case reports, sexual dysfunction may also persist for more than 10 years after discontinuation of treatment.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride 1 mg. If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping the treatment; permanent decrease in libido after stopping the treatment; permanent ejaculation problems after stopping the treatment.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation
• self-injury
• muscle-related disorders
• convulsions (seizures)

New information regarding the risk of muscle-related disorders has been added to the Post-Market Adverse Drug Reactions and Consumer Information sections of the Canadian product monographs for Proscar and Propecia…Rare cases of muscle-related disorders, such as rhabdomyolysis, myopathy, myalgia, myasthenia, and creatine kinase elevation, have been reported in patients treated with finasteride.

Health Canada reviewed the risk of suicidal thoughts and/or behaviours (suicidal ideation) with Proscar and Propecia (finasteride) use. The safety review was triggered because of Canadian and international reported cases of suicidal ideation and self-injury. Health Canada's review concluded that there may be a link between Proscar and Propecia...and the risk of suicidal ideation.

This safety review evaluated the risk of suicide, suicidal ideation and self-injury associated with the use of finasteride-containing products. [We] found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury... ealth Canada is working with the manufacturers to update the Canadian product monographs for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment.

Like any medicine, Propecia may cause side effects.

Propecia may cause changes in mood including extreme sadness... injuries from hurting yourself on purpose... and thoughts of suicide.... These mental health problems may continue even after you stop treatment.

• suicidal ideation
• self-injury

New information regarding the risk of muscle-related disorders has been added to the Post-Market Adverse Drug Reactions and Consumer Information sections of the Canadian product monographs for Proscar and Propecia…Rare cases of muscle-related disorders, such as rhabdomyolysis, myopathy, myalgia, myasthenia, and creatine kinase elevation, have been reported in patients treated with finasteride.

Health Canada reviewed the risk of suicidal thoughts and/or behaviours (suicidal ideation) with Proscar and Propecia (finasteride) use. The safety review was triggered because of Canadian and international reported cases of suicidal ideation and self-injury. Health Canada's review concluded that there may be a link between Proscar and Propecia...and the risk of suicidal ideation.

This safety review evaluated the risk of suicide, suicidal ideation and self-injury associated with the use of finasteride-containing products. [We] found a possible link between the use of finasteride and the risks of suicidal ideation and self-injury... ealth Canada is working with the manufacturers to update the Canadian product monographs for finasteride-containing products to strengthen the warning statements on the risks of suicidal ideation and self-injury, and to include information about patient screening for psychiatric risk factors prior to starting treatment, as well as continuous patient monitoring during and after stopping treatment.

Like any medicine, Propecia may cause side effects.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation
• self-injury

Rare cases…of depression, suicidal thoughts and sexual dysfunction have been identified in the UK in men being treated with finasteride… Patients treated with finasteride should be warned about the possibility of developing depressive disorders, as well as sexual dysfunction, while taking this medicine.

• loss of libido
• sexual dysfunction
• genital shrinkage
• depression
• anxiety
• suicidal ideation
• self-injury

The CMDh considered that the changes recommended for finasteride 1 mg tablets…should additionally be part of the single assessment outcome of this PSUR procedure. Further information…will be published on the [European Medicines Agency] website.

[T]he product information of medicinal products containing 5 mg finasteride…should be updated to include a warning on depression and suicidal ideation. [The Marketing Authorisation Holders]…should closely monitor events of suicide, suicidality and self-injury…The MAHs should also closely monitor events of penile size reduced and testicular atrophy. In addition, the MAHs should provide a cumulative review of anxiety [and] a cumulative review of reports describing sexual dysfunction-related events reported in conjunction with psychiatric disorder events… Finally, the MAHs…should provide a cumulative review of psychiatric disorders persisting after finasteride discontinuation.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood changes and depression: In patients treated with Accord finasteride, mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts… Side effects can occur... inability to get an erection that persists after stopping treatment, decreased sexual drive that persists after stopping treatment.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood swings, including depressed mood, depression and, rarely, suicidal ideation, have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and, if they do occur, patients should be advised to consult a physician… Psychiatric disorders [include] decreased libido, which continues after treatment, anxiety… Reproductive system [disorders include] sexual dysfunction…which continues after treatment.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

The [Danish Medicines Agency], has been contacted by several citizens who have experienced psychiatric adverse reactions in connection with a longer course of treatment with finasteride (1 mg) for hair loss… The issue was discussed at the last meeting in the European Pharmacovigilance Risk Assessment Committee, PRAC, which resolved to place a warning in the product information. The warning will describe that there have been reports of depression, mood changes and suicidal thoughts in treatment with finasteride for hair loss.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride... If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Orion finasteride... If you have any of these symptoms, stop taking Orion finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• sexual dysfunction
• penile atrophy
• pudendal neuralgia
• Peyronie’s disease
• memory loss
• language impairment
• migraine headaches
• liver damage
• heart rhythm disorders
• muscle or bone disorders
• tinnitus
• dry eyes
• anxiety
• panic attacks
• insomnia
• sleep apnea
• depression
• anhedonia
• suicidal ideation
• suicide attempt
• completed suicide

Patients have reported sexual disorders when using finasteride 1 mg. These may include erection disorders, ejaculation disorders…testicular pain, a decrease in libido, as well as male infertility problems and/or poor semen quality... Patients have also reported mental disorders, including anxiety, depression [and] suicidal thoughts that could lead to suicide. Symptoms of depression may include constant sadness, depression, loss of interest and pleasure, difficulty concentrating and remembering, reduced energy or fatigue (abnormal or even intense) and sleep disorders. All of these disorders can have an impact on social and professional life. Sexual and psychological disorders may persist after stopping treatment for an indefinite period.

Remember that finasteride 1 mg has a hormonal action and can cause mental disorders and sexual disorders… Given the nature of the adverse effects, in particular those of a psychological nature, it is advisable to schedule a follow-up consultation within three months after initiation of treatment, to assess its tolerance, then regularly (for example, every 6 months) during the treatment.

In our ongoing efforts to promote proper and safe use of finasteride 1 mg, we are making available…new tools designed in collaboration with the Association for Aid to the Victims of Finasteride [including] a “step-by-step” video, from the Network of Regional Pharmacovigilance Centers, to facilitate the reporting of adverse reactions associated with this drug.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Patients should be aware of the risk of sexual dysfunction (including erectile dysfunction, ejaculation disorder, and decreased libido) when starting finasteride therapy. Patients should also be informed that, based on individual patient case reports, sexual dysfunction may persist for more than 10 years after discontinuation of the therapy. Patients should also be advised that mood changes (including depressive mood, depression and suicidal thoughts) have been reported… On the recommendation of the European Medicines Agency, 'anxiety' is included as a new side effect.

[The US Food and Drug Administration]'s side effects database…showed that use of 1 mg finasteride in the indication of androgenetic alopecia could be associated with the risk of persistent sexual dysfunction due to disproportionate reporting rates. [S]tudies also indicated that sexual dysfunction could persist after discontinuation of finasteride [ranging] from months to years. The [Federal Institute for Drugs and Medical Devices] is aware of a case from Germany in which the reported sexual dysfunction persisted for more than 10 years… A total of 38 case reports on sexual dysfunction when taking finasteride are available in Germany, for which the outcome is given as “not recovered/not resolved.”

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Avelid finasteride... If you have any of these symptoms, stop taking Avelid finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Possible adverse reactions[:] permanent erectile dysfunction after stopping treatment, permanent decrease in libido after stopping treatment, permanent ejaculation problems after stopping treatment.

Psychiatric disorders: Depression, decreased libido that persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with STADA finasteride 1 mg... If you have any of these symptoms, stop taking STADA finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation

Reproductive system and breast disorders: Unknown: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with finasteride 5 mg... If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts, have been reported in patients treated with this medicine. If you experience any of these symptoms, stop taking ProAvenir and contact your doctor as soon as possible. Side effects of unknown frequency[:] persistent difficulty having an erection after discontinuation of treatment; persistent decrease in sex drive after discontinuation of treatment; persistent problems with ejaculation after discontinuation of treatment; male infertility and/or poor quality of semen; anxiety.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

There have been case reports of patients experiencing:
—sexual disorders, including erectile dysfunction, ejaculatory dysfunction, testiclular pain, and decreased libido;
—psychiatric disorders, such as anxiety, depression or even suicidal thoughts. All of these disorders can have a major impact on your social and personal life. The time to onset of the above symptoms can vary, from a few days to a few years after starting treatment. The duration of adverse effects can also vary widely from patient to patient. Adverse effects may persist after discontinuation of treatment and, in some cases, indefinitely.

• self-injurious ideation
• suicidal depression
• suicidal behavior
• suicide attempt
• completed suicide

A disproportionality analysis for reports of suicide-related events associated with finasteride… was performed using the dataset of the World Health Organization (WHO) Individual Case Safety Reports (ICSRs) Global Database (VigiBase) as of May 28, 2023. For finasteride, the number of adverse drug reaction reports of 'Depression suicidal,' 'Self-injurious ideation,' 'Completed suicide,' 'Suicidal behaviour,' 'Self-injurious ideation,' and 'Suicide attempt' was significantly higher than would be expected for the entire database. The results…suggested a relationship between finasteride and suicide-related events.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

[S]ide effects reported in some men [include] an inability to have an erection which may continue after stopping the medication, male infertility and/or poor quality of semen…depression, decrease in sex drive that may continue after stopping the medication, problems with ejaculation that may continue after stopping the medication, anxiety… Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Proscar.

• loss of libido
• sexual dysfunction

The [US Food and Drug Administration] has received information that after discontinuation of finasteride therapy, some patients have sexual side effects such as decreased libido, impaired ejaculation, decreased ejaculate, and impotence (in very rare cases)… According to a ruling by the FDA, the manufacturer included information on the decrease in libido and the possible development of male infertility while taking the drug.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

[D]epression (feelings of severe sadness and unworthiness) including suicidal thoughts. These are uncommon side effects that have been reported with [finasteride]... If you have any of these symptoms, stop taking Accord finasteride 1 mg film-coated tablets and contact your doctor as soon as possible.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Possible adverse reactions[:] permanent erectile dysfunction after stopping treatment, permanent decrease in libido after stopping treatment, permanent ejaculation problems after stopping treatment.

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

• loss of libido
• sexual dysfunction
• depression

Some men have also reported the following: allergic reactions such as rash; itching, hives and swelling of the lips, tongue, throat and face; testicular pain; an inability to have an erection that continued after stopping the medication; problems with ejaculation that continued after stopping the medication; male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication; depression; decrease in sex drive that continued after stopping the medication.

In general use, the following have been reported infrequently: breast tenderness and enlargement; depression; decrease in sex drive that continued after stopping the medication; allergic reactions including rash, itching, hives, and swelling of the lips and face; problems with ejaculation that continued after stopping the medication; testicular pain; difficulty in achieving an erection that continued after stopping the medication; male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

[D]epressed mood, depression and, less commonly, suicidal thoughts have been reported in patients taking finasteride. Patients should be evaluated for psychiatric disorders and, if they occur, the patient should seek medical help… Reproductive system and breast disorders [include] sexual dysfunction that may persist after treatment is stopped.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Possible adverse reactions [include] permanent erectile dysfunction after stopping treatment, permanent decrease in libido after stopping treatment, permanent ejaculation problems after stopping treatment.

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride... If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• erectile dysfunction
• loss of morning erections
• sexual anhedonia
• decreased semen volume
• penile shrinkage
• Peyronie’s disease
• scrotal shrinkage
• gynecomastia
• chronic fatigue
• muscle atrophy
• decreased oil production
• thinning of skin
• melasma
• tinnitus
• increased fat deposition
• lowered body temperature
• reduced HDL cholesterol
• suicidal ideation
• attempted suicide
• completed suicide
• memory impairment
• slowed thought processes
• cognitive dysfunction
• depression
• anxiety
• emotional flatness
• insomnia

Post-Finasteride Syndrome (PFS) was recently added to the US National Institutes of Health (NIH) list of genetic and rare diseases… PFS includes sexual, physical, and mental and neurological symptoms in patients who have taken finasteride. Symptoms often persist after the patient has stopped taking finasteride…Importantly, some patients can experience suicidal ideation and depression after stopping finasteride treatment. Patients and their families should be advised about these symptoms and to seek medical advice as soon as possible if they occur.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with finasteride 1 mg film-coated tablets. If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation
• self-injury
• muscle-related disorders

Health Canada analyzed the risk of possible serious muscle-related side effects with the use of finasteride… At the time of the review, Health Canada had received 11 reports of serious muscle-related side effects suspected to be related to the use of finasteride… Health Canada’s review of the available information concluded that the risk of serious muscle-related side effects with the use of finasteride could not be ruled out.

Health Canada conducted a safety review for finasteride, due to reported cases of suicidal ideation and self-harm received in Canada and internationally. The cases led to the investigation of a possible relationship between finasteride use and suicidal ideation… Between 2012 and 2016, the reporting rate in Canada for finasteride-related adverse reactions and suicide/self-harm increased 2.5-fold.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation

[T]he European Medicines Agency published the scientific conclusions referring to the evaluation of the Periodic Safety Reports for finasteride. The evaluation was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), which observed that during the reference period two serious cases were obtained for finasteride 5 mg, one in which suicidal behavior was reported and in the other case suicidal ideation. Cumulatively, 51 cases of suicidal ideation have been obtained according to the information in the summary table of adverse drug reactions during post-marketing use.

After initiation of finasteride, observe patients for psychiatric problems. Advise patients to discontinue finasteride treatment if they develop mood disturbances, depression, and suicidal ideation… Instruct patients to inform their physician if they experience mood swings, depression and/or suicidal ideation while taking finasteride.

• anxiety

Based on the reported cases of anxiety related to treatment with finasteride…and also taking into account that a high prevalence of anxiety in patients with MPHL has been confirmed, the PRAC considered that the adverse drug reaction anxiety should be included in…the Summary of Product Characteristics of all finasteride-containing products, with a frequency not known. The package leaflet is updated accordingly.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• gynecomastia
• suicidal ideation

Interactions to keep in mind! Potentiation of depression, suicidal ideation with: finasteride, dutasteride.

Gynecomastia is not rare in adult men… [It] also appears as a side effect of medicines. The authors of this study undertook a systematic literature review encompassing articles from over one hundred publications. The result was the following list of medicines that are potentially associated with the occurrence of gynecomastia… finasteride.

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride... If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible for additional medical help… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

In patients treated with finasteride, mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts. If you notice any of these symptoms, consult your doctor immediately… Side effects can occur [including] inability to get an erection that persists after stopping treatment [and] decreased sexual drive that persists after stopping treatment.

• depression
• suicidal ideation

[T]he Ministry of Health of the Russian Federation informs you that it is necessary to make changes to the instructions for use of…finasteride…according to updated information on experience based on their clinical application… The following information must be included… 'It is indicated that mood changes, including depression and suicidal ideation, were observed in patients taking finasteride at a dose of 5 mg. It is necessary to monitor the appearance of psychopathological symptoms and, when they take place, patients should be referred for consultation with a specialist.'

• diabetes mellitus
• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

[T]he Saudi Food & Drug Authority inform[s] you about the below safety aspects[:] Patients should be aware of the risk of experiencing the adverse event (AE) of sexual dysfunction (including erectile dysfunction, ejaculation disorder, and decreased libido) during finasteride therapy. Patients should also be informed that case reports have been received of sexual dysfunction AEs that persisted after discontinuation of therapy...Healthcare Professionals should carefully monitor patients during treatment with finasteride for psychiatric symptoms (including anxiety, depression and suicidal ideation).

The weighted cumulative evidence identified from the reported cases, literature and data mining are sufficient to support a causal association between Finasteride and the risk of Diabetes Mellitus. Health regulators and health care professionals must be aware of this potential risk and it is advisable to monitor any signs or symptoms in treated patients.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

In patients treated with finasteride [symptoms included] mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts. If you notice any of these symptoms, consult your doctor immediately… Side effects can occur [including] inability to get an erection that persists after stopping treatment [and] decreased sexual drive that persists after stopping treatment.

• depression
• suicidal ideation

Mood alterations including depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride. Healthcare professionals are advised to consider the potential risk of psychological AEs when assessing the benefit-risk of finasteride for their patients.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation
disorders) that continued after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation

Stop using [finasteride] and immediately contact a doctor if you experience any of the following symptoms[:] persistent difficulty having an erection after discontinuation of treatment, persistent decrease in sex drive after discontinuation of treatment, persistent problems with ejaculation after discontinuation of treatment.

[T]he following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after discontinuation of treatment with finasteride.

• loss of libido
• sexual dysfunction
• depression

The following additional adverse experiences have been reported in post-marketing use[:] Depression, decreased libido that continued after discontinuation of treatment… Breast tenderness and enlargement, testicular pain, haematospermia, sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, male infertility and/or poor seminal quality.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation

Warning: Mood swings including depressed mood, depression and suicidal thoughts were reported by patients treated with 1 mg of finasteride. Please make sure to observe patients for psychological symptoms. If any of the above symptoms are found in a patient, stop the treatment with finasteride and consult a medical provider.

Warning labels will be added to finasteride…noting that [it] may cause side effects including depression and suicidal thoughts, among other things. [T]he Ministry of Food and Drug Safety announced the warning…based on a safety report submitted by Merck Sharp & Dohme Korea, which originally developed the drug…Propecia was released in the Korean market in 2000. When its patent expired in 2008, several generic drugs were also released...There are presently more than 60 generic hair-loss drugs and 70 generic prostate-enlargement drugs on the market that have the same ingredients as Propecia.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Cases of mood disturbances, including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 5 mg. This information will be included in the warning section of the drug’s data sheet together with the recommendation to monitor patients for the appearance of psychiatric symptoms and, if these occur, instruct them to seek medical advice.

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

In the SmPC [Summary of Product Characteristics] for Propecia, it is stated that adverse reactions usually have resolved themselves while on treatment or after cessation of therapy... This was supported by clinical data presented before the approval. After the approval, reported spontaneous reports received from [healthcare personnel] have regularly been presented... The most frequently reported adverse reactions...were erectile dysfunction, gynaecomastia and testicular pain. Within the cumulative submitted documentation, no new data has been presented indicating an increasing problem with male reproductive system symptoms...not being reversible after cessation of therapy.

With regards to the MPA request to update section 4.4 of the SPC with information on the persistence of erectile dysfunction after cessation of treatment, MSD wishes to confirm our position that the pre-clinical, clinical and post-marketing data do not support inclusion of precautionary text in the SPC.

The second report…concerned a 19-year-old male, who was placed on finasteride 1 mg... Subsequently the patient experienced erectile dysfunction, gynaecomastia, fatigue and feeling ‘mentally unclear.’ Finasteride was discontinued. The patient’s experiences persisted for almost two years [and] laboratory test results were normal.

Comments on [labeling]: Section 4.8 should be revised according to the Guideline on Summary Product characteristics. The first sentence ‘Undesirable effects have usually been transient during treatment or resolved upon discontinuation’ should be deleted.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation

Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that persists after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

• loss of libido
• sexual dysfunction
• depression

Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation
disorders) that continued after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

• muscle-related disorders

Health Canada recently recommended adding a warning to products containing [finasteride]... While being administered the above-mentioned drug, patients may develop muscle weakness and stiffness, which in turn may cause pain to the patient, damage to muscle tissue and an increase in kinase enzymes. Accordingly, Health Canada and the UAE Ministry of Health recommend that companies that produce products containing [finasteride] add the above-mentioned warning to the internal leaflet of their products.

• loss of libido
• sexual dysfunction
• anxiety
• depression
• suicidal ideation
• completed suicide

The MHRA completed a review of the safety of finasteride following concerns raised by patients regarding a lack of awareness of these side effects amongst patients and healthcare professionals. The MHRA reviewed the available evidence, including Yellow Card reports, published scientific literature and actions by other regulators [and] noted that the product information for finasteride contains information regarding the risk of depression and suicidal ideation and the potential of persistent sexual side effects after discontinuation with finasteride. However, these side effects do not appear to be well known by prescribers and patients, and therefore recommended the introduction of a patient card to increase awareness about these risks.

Some men have reported episodes of depressive illness in association with the use of Propecia... Some men also reported having suicidal thoughts. Depression and suicidal thoughts have been reported in men with and without a previous history of depression... A recent review of the evidence has suggested more significant depression can occur and so the advice is being updated to reflect this.

• loss of libido
• sexual dysfunction
• depression
• suicidal ideation and behavior

What are the possible side effects of Propecia?

What are the possible side effects of Propecia?

What are the possible side effects of Propecia?

Postmarketing Experience

FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks regarding growth, development and sexual function. Any proposed use in the pediatric population would, of course, need to account for these safety concerns. Accordingly, your petition is denied.