Androgenic alopecia is a hair loss condition that primarily affects the top and front of the scalp. Credit: PippiLongstocking via Shutterstock.
The European Medicines Agency (EMA) has started a review of popular anti-baldness and enlarged prostate medicines finasteride and dutasteride over concerns about their possible impact on causing suicidal thoughts.
Finasteride is marketed as Propecia for male pattern hair loss (androgenetic alopecia) and Proscar for treating benign prostatic hyperplasia (BPH), by MSD’s spin-off company Organon. BPH is a condition in which the prostate is enlarged causing problems with the flow of urine. Dutasteride, which is marketed by GSK as Avodart, has a similar mechanism of action and is used to treat BPH. Avodart is also sometimes used off label for hair loss, with generic versions of finasteride and dutasteride available in the market.
The safety review was requested by the French regulatory agency, the National Agency for the Safety of Medicines and Health Products, which said that all available data on suicidal ideation and suicide related to finasteride and dutasteride-containing products as well as the impact of these possible risks on the benefit-risk balance of these products should be reviewed.
Finasteride and dutasteride are linked to psychiatric side effects according to French regulators. Suicidal ideation was recently added to the patient information sheets and packaging for both Propecia and Proscar in the EU. However, French authorities argue that the new safety reports alter the risk profile of finasteride.
This was highlighted in the 4 October Article-31 referral document: “Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility, given that known ADRs (adverse drug reactions) such as sexual dysfunction/impotence, depression, decreased libido, may lead to suicidal ideation.”
This is not the first time that questions have been raised about the psychiatric symptoms of these drugs. In June 2022, the US Food and Drug Administration (FDA) ordered a warning about suicidal thoughts and behaviour on the drug’s label but rejected a request to remove Propecia from the market. This followed a 2017 petition from a patient advocacy group called the Post-Finasteride Syndrome Foundation, which ordered MSD to either stop selling the drug or require stronger warnings.
Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
View profiles in store
Company Profile – free
sample
Your download email will arrive shortly
We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form
By GlobalData
Country *
UK
USA
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint
Eustatius
and
Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean
Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos Islands
Colombia
Comoros
Congo
Democratic Republic
of
the Congo
Cook Islands
Costa Rica
Côte d”Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern
Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and
McDonald
Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya
Liechtenstein
Lithuania
Luxembourg
Macao
Macedonia,
The
Former
Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint
Helena,
Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and
The
Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South
Georgia
and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo
Industry *
Academia & Education
Aerospace, Defense &
Security
Agriculture
Asset Management
Automotive
Banking & Payments
Chemicals
Construction
Consumer
Foodservice
Government, trade bodies
and NGOs
Health & Fitness
Hospitals & Healthcare
HR, Staffing &
Recruitment
Insurance
Investment Banking
Legal Services
Management Consulting
Marketing & Advertising
Media & Publishing
Medical Devices
Mining
Oil & Gas
Packaging
Pharmaceuticals
Power & Utilities
Private Equity
Real Estate
Retail
Sport
Technology
Telecom
Transportation &
Logistics
Travel, Tourism &
Hospitality
Venture Capital
Tick here to opt out of curated industry news, reports, and event updates from Pharmaceutical Technology.
Submit and
download
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects.
Androgenetic alopecia or pattern balding is the main cause of hair loss in men but affects both men and women. According to GlobalData, there are 49 drugs in development for the condition.
GlobalData is the parent company of Pharmaceutical Technology.
