BREAKING NEWS: MERCK USA updates Propecia labeling to include "erectile dysfunction that continued after discontinuation of treatment"


#1

As of April 2011, Merck has updated the USA Propecia leaflet:

Pg 3. merck.com/product/usa/pi_circulars/p/propecia/propecia_ppi.pdf

Pg 10 - merck.com/product/usa/pi_circulars/p/propecia/propecia_pi.pdf

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#2

Mew,

The TRUTH is exposed…Finally


#3

Since they now acknowlege that this is a problem, what about a solution, what about the people they did this to? They just put a couple phrases in a leaflet and that’s it? Where is the FDA? Why is this still legal? I know I’m the master of the obvious, but this is unreal…


#4

It essentially is Merck saying we are right. I’m not sure, they must have calculated their losses long-term, but with the pressure of the media, lawsuits and Dr. Irwig’s study, it seems they have caved in. There is no taking back this position for them now…


#5

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal ‘relationship’ to drug exposure.”

  • so Merck is saying that its just common man’s experice with the drug, they havent found this to be true during their trials. So its not a ‘side effect’ that they can verify. Basically they can play around saying that random people using this could be paranoid and have some other health issues etc.

#6

Well, then MSD will have a hard time explaining why there is no disclaimer saying “it is not always possible to […] establish a causal ‘relationship’ to drug exposure” in the Patient Information Leaflet (PIL) MSD uses for Propecia in for example the UK, Sweden, Italy, and Denmark.

Normally, the PIL is not updated with new side effects unless there is sufficient information (e.g. from side effect reports and/or medical articles) that indicate that the drug causes the side effect. For example, if there are reports of new side effects, but when evaluated there is not sufficient evidence that the drug caused the side effect (e.g. since the patient was taking other drugs at the same time that could also cause the side effect), then the side effect will not be added to the PIL. Seems like MSD wants to say “there is sufficient evidence that Propecia causes persistent sexual side effects so it should be added to the PIL” and at the same time “but the evidence is not sufficient after all”. Very weird. Please make up your mind!

I suppose they are adding the text to avoid any new lawsuits caused by not telling the US patients what they already have told patients in other coutries. If they have already agreed to that Propecia causes peristent side effects in other countries, it would be hard to explain why they didn’t tell the US patients. Also, any patient taking Propecia from now on will have no chance of winning a lawsuit since the warning info is in the PIL. In addition they add the disclaimer to avoid agreeing to that it is certain that Propecia causes these side effects. That way they are trying to also win any lawsuits filed by patients that have taken the drug prior to the new text being added.

It would be interesting to hear what the law firms handling the Propecia Class Action Lawsuits have to say about this?

It would also be interesting to hear what the FDA has to say about this. Did the FDA force MSD to add the new text, or did MSD do it voluntarily? And does the FDA make a different judgement than the corresponding medical authorities in the other countries that have updated the PIL (particularily regarding the casual relationship between the persistent side effect and Propecia)?