New: FDA Warns of High-Grade Prostate Cancer Risk w Avodart

[howudoin]

Although this was mentioned a while ago, according to new news articles early this month (June 2011), the FDA has now issued a warning about "increased high-grade prostate cancer risk" with Avodart and Propecia, and is requiring the manufacturers to put a warning on the product.

Whilst it decreases low-grade risk, it increases high-grade risk - a more serious form of cancer.

"This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," the agency wrote in its safety announcement.

"In the REDUCE trial, 29 high-grade tumors were found among patients being treated with dutasteride compared with 19 in the placebo group. In the PCPT, there was a 26% decrease in all prostate cancers but an absolute increase of 1.3% in the incidence of high-grade tumors."

"According to an FDA statistician who spoke at the December advisory committee meeting, if 200 men are treated with the drugs, it is expected that there will be one additional tumor with a Gleason score of 8 to 10."

By my reckoning that equals a 0.5% increase in risk.

Sources: http://goo.gl/hlfHO

Will you be stopping taking Avodart or Propecia?

 

[HughJass]

has anyone got the full text for the REDUCE trial?

 

[Rutt]

1.3%


hell no i'm not stopping, in fact im going from 1mg finasteride to 1mg dutasteride, possibly more depending on how it goes. i will go as high as 2.5mg if it continues, although i believe it has halted and thickened with just 1mg finasteride.

 

[kumarhk]

Read somewhere or heard it on the news that the increase may be due to the fact that avodart shrinks the benign tumor so much that this allows easier access to the smaller high risk tumor (malignant?) during a biopsy. So if this is the case, then even though the percentage of high grade prostate cancer is increased you are still in luck of having caught the tumor early since it was going to develop anyways. Basically its like looking for a needle in a haystack without avodart versus looking for a basketball among soccer balls with it (I know its a bad analogy, sorry)

 

[Wuffer]

Some feel this is being misconstrued:

http://www.thebaldtruth.com/hair-loss/p ... ncer-risk/

According to Otis Brawley, M.D., chief medical officer and executive vice president of the American Cancer Society, this latest FDA warning has been misinterpreted by many and he felt it was important to set the record straight.

On one hand, it's the FDA.. on the other, a chief medical officer at the ACS must know a thing or two about cancer. Draw your own conclusions I guess.

 

[Gizmo]

has anyone got the full text for the REDUCE trial?

I would like to know this too