US leaflet mentions persistent side effects?

General Discussion
#1

Hi,
As I am planning a few actions (either legal or through the press) in Latin America, it would be very useful to know if the leaflets of Finasteride (Propecia or generic brands) in the US mention the possibility of persistent side effects.
And in that case, do you know when they were added?

Thanks!

#2

The FDA made two relevant label changes.

The first fraudulent stealth change occurred in 2002 and was detailed in the recent Reuters news article that came out.

  • Prior to 2002, the label said “Resolution occurred in all men who discontinued therapy with PROPECIA due to these side effects and in 58% of those who continued therapy”
  • After 2002, they changed the label to say “Resolution occurred in men who discontinued therapy with PROPECIA due to these side effects and in most of those who continued therapy.”

The article explains the change in full and then you can click the deposition link to see the interview with the woman who was in charge of managing the label with the FDA. Of course you’ll note that the updated label in no way informs patients of the risks of persistent side effects, but they changed the label in this sneaky way to make it seem as though they were adequately warning the public and FDA.


The second more visible change occurred in April 2012 and was a result of the FDA requiring Merck to change the label. The label began to warn of post marketing reports of persisting sexual dysfunction.

Good luck with things in Latin America. It is less relevant for you, but many other countries began to warn citizens of the risks of their drug before the FDA did. Unless your country uses the FDA label, this probably won’t matter.

#3

Worth noting that legal action before the full story is understood may not be the best course of action.

#4

Thanks a lot. I will read this material in detail and keep you posted!

#5

At this point, it is very clear that Merck defrauded the public regarding the side effects and there’s evidence all over the warning label.

South American systems will have their own procedures and standards for proving that the drug injured you etc. Even though you may very clearly have PFS and it is clear Merck lied about the risks, the truth is not always enough.

Some guys come in here thinking the legal system will definitely be on their side but it is very arduous and difficult to attain justice. Greek is right in that you need to do your own research about what it would take before even think about getting your hopes up.

#6

Thanks @Frustrated
I totally agree that a legal action against the Pharma industry is extremely complicated and usually unaffordable for a single person.
But there are several paths I could follow, for example suing the local “FDA” because they didn’t include the warning the US FDA added in 2012 (I took Finasteride in 2015, and no warnings about persistent side effects were mentioned in the label).