Friday, June 10, 2022

Warning: FDA Adds A "Suicidal Ideation" Warning On Men's Baldness Drug Called Propecia -- [Now An Organon Product]: Finasteride.


For well over a decade, we had historically covered the federal finasteride (Propecia®) products liability class action. Here is one of literally hundreds of those posts, as background. [Feel free to search the term "Propecia" in the above left search bar/box, for them all, sorted by relevance -- or date. Of course, it is no longer sold by Merck, but by the spin-off, Organon, as of last year.]

We had studiously avoided any mention of a potential off target effect, related to suicidal ideation, though several public documents made at least passing mention of that possibility, feeling it would be intemperate to make such an association, if the US FDA had not done so. In any event, in the end, the EU authorities added a warning to the labeling for the EU version of finasteride -- arguing essentially that even though the risk looked small, the male pattern baldness drug was not for any life-threatening condition -- and so, since it was taken for strictly cosmetic reasons, the public ought to know what all the even remotely possible off target effects might be. With hind-sight, that may have been a wiser approach than the one our own US FDA took.

But this post is not intended to (belatedly) take any position on the underlying data, or adverse event reports, from over the past decade. We post it solely to let the readership know that Reuters was able to win an unsealing order as to certain of those finasteride Merck documents -- and the readers (if interested) ought to decide for themselves what to make of them. Here's a bit of the Reuters reporting from late 2021 -- and today's news, also from 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. . . .


Now you know. . . and a 14 year (minimum) narrative arc, here continues. Smile. . . .

नमस्ते

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