Controversy? FDA warns hair loss, BPH meds increase prostate cancer risk. Or not...

The FDA now warns that Proscar, Propecia, Avodart and Jalyn increase the risk of high-grade prostate cancer. But not every expert agrees, including the chief medical officer of the American Cancer Society.

Bloomberg reports: Merck and GlaxoSmithKline Plc (GSK)’s drugs for hair loss and enlarged prostate will carry new U.S. warnings about a low risk of being diagnosed with a more serious form of prostate cancer.

The Food and Drug Administration revised the prescribing information for Merck’s Proscar and Propecia and Glaxo’s Avodart and Jalyn based on the findings of two studies, the agency said today in a statement. From 2002 to 2009 about 5 million men were prescribed one of these drugs, known as 5-ARIs, including almost 3 million men ages 50 to 79, the FDA said. (Merck, Glaxo Drugs Add Warnings About Prostate Cancer Risk – Bloomberg.)

However, Otis Brawley, chief medical officer of the American Cancer Society and a prostate cancer doctor himself, wrote to Forbes’ MatthewHerper:

“I and most docs who have reviewed the data believe that these drugs cause small high grade tumors that already exist to be more easily diagnosed by shrinking the normal prostate and not the cancer within it.  It is does not cause high grade cancer in my opinion. There are a small number of people who think these drugs might cause high grade cancer.  I seriously do not see evidence for that.”

About these drugs

The male hair-loss drug Propecia has the same active ingredient as Proscar, although at one-fifth the dose. But the FDA says Propecia should carry the same 
prostate cancer warning as Proscar.

 Proscar, Avodart, and Propecia are 
in the same class of drugs, known 
as 5-alpha-reductase inhibitors or 
5-ARIs. Jalyn has the same active 
ingredient as Avodart, together 
with a drug called tamsulosin 
Flomax. 
The FDA warning does not include 
Flomax, which is in a different 
class of prostate drugs called alpha blockers. Other alpha blockers include Cardura, Hytrin, Uroxetral, and Rapaflow. But Flomax and these other alpha blockers produce a whole different set of problems.