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
• 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
• 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

[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
• 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.

• 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
• 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

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 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
• 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

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
• 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

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.

• 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
• 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
• 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

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
• 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
• 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.

• 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
• 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.

• 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.

• 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
• 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
• 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

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
• 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.

• 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.