Dutasteride Black Box Warning Label is Inappropriate.

[janebob99]

This plot that I made goes back to the original paper by Thompson et al. (2003), that was the basis for slapping the Black Box Warning Label on Dutasteride prescriptions.

pubmed.ncbi.nlm.nih.gov/128...

There are some important points that should be considered:

(1) Thompson only studied Finesteride, not Dutasteride;

(2) The absolute difference in % of men who have high-grade prostate cancer (GS = 8, 9, 10) is very small (only 1%), as shown in the plot: 6% for men on Finesteride and 5% for Placebo. That's within the noise and is not statistically significant.

(3) Thompson et al. speculated in their paper that the large shrinkage of the prostate (~25%) when on Finesteride may cause an error (a "bias") that "affects the evidence".

It is true that the probability of a random biopsy needle hitting a tumor increases as the prostate volume decreases, (assuming that the number of tumors remains the same before and after Finesteride). That factor is called a "detection bias".

pubmed.ncbi.nlm.nih.gov/17848668/

After Thompson et al. was published, doctors and researchers have written papers/comments that the black box warning label on Finesteride and Dutasteride should be removed.

I agree!!

Bob Watson

[Justfor_]

No catastrophising on the other side of the pond.

[janebob99 in reply to Justfor_]

What do you mean?

[Justfor_ in reply to janebob99]

No silly warnings on the Avodart box, apart from: "To be used by men only".

[janebob99 in reply to Justfor_]

Gosh, maybe they removed the label! I will investigate. Thanks!

[janebob99 in reply to janebob99]

I checked ChatGPT, and you are correct. There is no warning in the UK for high-grade PCa. Only in the USA. Good catch !

[lancer82801]

To me this is a problem that should at least be discussed prior to treatment

Video for your information

[j-o-h-n]

Blimey, It may be on the left side........... Yanks on the right side.........

Good Luck, Good Health and Good Humor.

j-o-h-n