How can 5 Cancers suspected by a drug's supplier not be a "side effect".

I was treated for Benign Prostate Hyperplasia/Hypertrophy (BPH) since 1990. In 2006 I war prescribed Alpha Blockers (Flomaxtra then Prazosin) 4mg a day. They worked but left some difficult and some less painful voiding plus overnight necessities. Bladder capacity was shrinking and no consideration was made of the impact this Alpha altering of bladder neck muscles and nerves would have if a prostatectomy were to follow. I could always tell if I missed an afternoon or morning 2mg dose though. I did not know that since 1995 urologists had known Prazosin would need an increase in its 4mg dosage beyond 2 years. By 2015 still no one had bothered to do the research. In 2013 when I advised my GP that Prazosin was becoming less effective and requested an increase to 6mg a day Duodart was recommended. After referral it was then prescribed Duodart by my former urologist March 2013 to March 2014. Gleason Score 3+4=7 and Open Radical Prostatectomy followed in November 2015 and then long and hard partial recovery and so far 2 years of incontinence. My PSA never went above 3.8 (Apl 2009) and was 2.41 (f/t38%) inJuly 2015 long after Duodart’s affect on IT had ceased.

Duodart contains the active ingredients Dutasteride and Tamsulosin Hydrochloride (Flomaxtra).The Urologist instructed me to continue taking the Prazosin with the Duodart for this period. This was later confirmed by GP. I later learned this was contrary to Duodart’s Comsumer Medicine Information (CMI) as Duodart contains Flomaxtra and took my Alpha blocking dose to 8mg a day. Higher than the un-researched 6mg I initially sought.

Dutasteride manipulates testosterone to alter prostate cell structure to mostly reduce prostate size. I was told side effects could include headaches and dizziness as well as affect sexual stimulation and ejaculation. There was no mention of the much more serious possibility of initiating high grade prostate cancer (PCa). This was a factor in the drug’s pre-release trials but Prostate Cancer is still not listed as a “side effect”.

The drug’s Australian supplier has since reported 5 de-identified suspected Adverse Drug Reaction (ADR) of PCa to our Therapeutic Goods Administration’s (TGA) Database of Adverse Events Notifications DAEN. Reports omit age and Gleason Score even though neither would breach privacy guidelines. The DAEN database even includes an age column. The number of this drug’s Australian users would be vast. As PCa is not listed as a “side effect” on the drug’s CMI most Urologists don’t even mention this risk.

The drug supplier believes the drug reduces the risk of low-grade PCa and allays a risk of increased high-grade cancer as pre-release study design. The one thing trials proved was a high percentage of any men that would need to take the drug would progress to PCa no matter what. TGA says drug suppliers are bound to report “serious” adverse events to TGA. To do this they must have some feedback which could only come from Urologists, Pathologists, hospitals or patients. My suspect adverse PCa reaction failed to reach the DAEN via the company even though the company told me they had created a report for it.

It’s difficult to see how the company could isolate their 5 from what would be thousands of other Duodart user’s Cancers not suspected. The drug company is running the show. They decide if sufferers prescribed Duodart are told of this possible risk or not. I believe men in the USA have an opportunity to make their “risk vs benefits” decisions after evaluating this risk. We are not, it’s hidden here. The only way Australian men could learn of the drug companies own 5 suspected cases would be to access the DAEN. Most would not. Our Health Administrators must get involved here. Find out what data the supplier has or better get their own. It’s wrong to use what the supplier has indicated as flawed trial outcomes and ignore subsequent actual results.

No one else is doing anything so I am trying to do some feedback research of my own. I am trying to compare the timing and circumstances of my progression with others. If you have or know someone with a similar pathway to PCa let me know the details.

Barrie H

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