Finasteride Propecia

FINASTERIDE - PROPECIA -  PROSCAR

'Propecia' is indicated for the treatment of only men, with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.

AND

Finasteride is used to treat men with prostate problems

The UK British National Formulary (BNF)   published this information on their web site about the side effects of Finasteride

https://bnf.nice.org.uk/drugs/finasteride/#side-effects 

Important safety information

For finasteride

MHRA/CHM advice: rare reports of depression and suicidal thoughts (May 2017)

For Propecia this site has manufacturer’s information

https://www.medicines.org.uk/emc/product/2194

For Finasteride this is the link: https://www.medicines.org.uk/emc/product/13542/smpc

When accessing  the official summary (SmPC) look at the date of updates as the generic suppliers of drugs may not follow the actual manufacturers updates.

also the Patient Information Leaflets (PILs) may omit vital information.

If any links are not effective just go to the main website https://www.medicines.org.uk/emc/

and input the name of the drug you are researching. Familiarise yourself with all the names it may be listed under.

4.1 Therapeutic indications

'Propecia' is indicated for the treatment of only men, with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.

AND

Finasteride is used to treat men with an enlarged prostate

Crushed or broken tablets of 'Propecia' should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see section 4.6 Fertility, pregnancy and lactation). 'Propecia' tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

It is also used for prostate problems: Finasteride is used to treat men with an enlarged prostate (benign prostate enlargement).

NHS website information about Finasteride

https://www.nhs.uk/medicines/finasteride/ 

Key facts on the NHS web site are:

• The main side effects are losing interest in sex and difficulty getting an erection.
• Finasteride can affect the results of PSA testing (a blood test to check for prostate cancer)
• This medicine gets into semen and can harm an unborn baby. Use a condom when having sex if your partner is pregnant or could get pregnant.
• If you're pregnant or trying to get pregnant, do not touch crushed or broken finasteride tablets. If the tablets are broken, the medicine can pass through your skin and can harm your baby.

The following is from the Summary of Product Characteristics (SmPC) published for the manufacturers on the web site www.medices.org.uk  for Organon:

https://www.medicines.org.uk/emc/product/1008/smpc It is a legally required summary that all prescribers should read.

10. Date of revision of the text

26 April 2021

© Organon Pharma (UK) Limited 2021. All rights reserved.

4.4 Special warnings and precautions for use

Hepatic impairment

The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.

Hepatic impairment

The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.

Hepatic encephalopathy is a nervous system disorder brought on by severe liver disease. When the liver doesn’t work properly, toxins build up in the blood. These toxins can travel to the brain and affect brain function.

Breast Cancer

Breast cancer has been reported in men taking finasteride 1 mg during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge.

Mood alterations and depression

Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 1 mg. Patients should be monitored for psychiatric symptoms and if these occur, treatment with finasteride should be discontinued and the patient advised to seek medical advice.

Lactose intolerance

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

REPORTS of ADRs listed on the MHRA website - The MHRA agree less than 10% of serious ADRs are reported.

https://yellowcard.mhra.gov.uk/iDAPs

A list of reports from https://yellowcard.mhra.gov.uk/iDAPs

Another useful resource for your own research is the web site with a list of reported Adverse Drug Reactions ( ADRs) using the UK Yellow Card System. Contains some reports by the public as well as a few doctors and pharmacists. Rarely a Coroner may also report. Even more rare is for the actual manufacturer or generic provider to report ADRs.

Some of the reports found January 2023 but you can review the data  for many drugs here:

https://yellowcard.mhra.gov.uk/iDAPs

Interactive Drug Analysis Profiles are large documents and here is an example of ADR reports for just three serious ADRs, column on right records deaths.

Total reactions recorded by the MHRA. 2640 and 23 Deaths

Few records are reported to the regulator so average this could be just 10% of actual ADRs.

USA News on this drug - June 2022 re Post Finaseride Syndrome and suicidal ideation in men taking Propecia

FDA requires disclosure of suicide risk for anti-baldness drug

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-requires-disclosure-suicide-risk-anti-baldness-drug-2022-06-10/ 

June 10 2022 (Reuters) - U.S. health regulators rejected a request to remove popular anti-baldness pill Propecia and its generic versions from the market, but for the first time required patient notification about reports of suicidal behavior in men taking the drug.

The U.S. Food and Drug Administration has previously approved revised Propecia labels that mentioned risks of persistent sexual dysfunction and depression but not suicide. A patient advocacy group, the Post-Finasteride Syndrome Foundation, petitioned the FDA in 2017 to order Merck & Co (MRK.N) to either stop selling the drug or require far stronger warnings, citing several scientific studies. Finasteride is the generic name for Propecia.

In a response this week, the FDA said the group's petition "does not provide reasonable evidence" of a causal link between Propecia and persistent sexual problems, depression or suicide. However, based on patient reports, the FDA said it is "requiring the addition of suicidal ideation and behavior" to the adverse reactions listed on Propecia's label.