1. Pink Sheet
  2. >>Geography
  3. >>Europe

EU Launches Safety Review Of Finasteride And Dutasteride Over Suicidal Thoughts And Behavior

 
• By Ian Schofield

France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile. 

Businessman showing risk level indicator rating since low to high for risk management and assessment review concept
The EU is weighing the risks of two 5-alpha reductase inhibitors • Source: Shutterstock

The European Medicines Agency has launched a safety review of medicines containing finasteride and dutasteride after the French regulator raised concerns about continuing reports of psychiatric disorders including suicidal ideation and sexual dysfunction, despite the measures that have been taken to address these potential side-effects.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

Semaglutide For MASH Among Raft Of New EU Filings

 
• By Neena Brizmohun

Novo Nordisk’s application seeking EU marketing approval to use its GLP-1 receptor agonist to treat cirrhotic metabolic dysfunction-associated steatohepatitis is one of 15 new drug filings the European Medicines Agency has started reviewing. Meanwhile, Arrowhead’s filing for its familial chylomicronemia syndrome, plozasiran, is being fast tracked.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

More from Geography

Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 
• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
• By Francesca Bruce

Nirogacestat was one of four products scheduled for an oral explanation meeting at the European Medicines Agency this week.

Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
• By Bridget Silverman

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.