Quote from: Richenda on June 16, 2016, 12:43:09 AM
Good. But to be fair, Kay, you have championed bicalutamide all over the internet, rather carelessly declaring it to be a 'safe drug' when that is, at the very least, unproven.
I was basing myself on the following, and I take special care in making assertions. I also make it clear I am not a doctor and I share information/studies for others to come to their own conclusions with their doctors.
Urology. 1996 Jan;47(1A Suppl):70-9; discussion 80-4."To evaluate bicalutamide as a therapy
in nearly 3000 patients with advanced prostate cancer and to determine the dose-ranging, pharmacodynamic, and pharmacokinetic properties of bicalutamide. To evaluate bicalutamide as a monotherapy or in combination with luteinizing hormone-releasing hormone analogue (LHRH-A) therapy."
"
With a total exposure of > 2800 patient-years, bicalutamide has been shown to be a well-tolerated therapy with a low incidence of treatment-related withdrawals."
"Bicalutamide is a new antiandrogen that offers the convenience of once-daily administration, demonstrated activity in prostate cancer, and an
excellent safety profile."
Eur Urol. 1994;26 Suppl 1:15-9."Over 3,000 men, the majority of whom were patients with prostate cancer, were treated with Casodex (ICI 176,334), an oral anti-androgen, at doses ranging from (...) daily, corresponding to a total exposure to the drug of over 1,500 patient-years"
"Over this period, the tolerability of Casodex and its effect on quality of life were closely studied. Information on tolerability is presented from three large randomized trials of Casodex"
"The most commonly reported adverse events were those that would be expected with an anti-androgen (i.e. breast tenderness, gynaecomastia and hot flushes).
Overall, Casodex was well tolerated; there were no reports of light/dark adaptation problems or pulmonary fibrosis, and only one case of alcohol intolerance, which was not considered by the investigator to be treatment related.
Only 0.3% of patients in the whole trial programme had to be withdrawn because of changes in liver function, and there were no clinically significant changes in mean liver function tests."
Eur Urol. 1998;33(1):39-53."To evaluate the efficacy, tolerability, endocrinological effects and the pharmacokinetics of Casodex, when given as monotherapy"
"A total of 390 patients with advanced prostate cancer were treated for a minimum of 12 weeks with a daily monotherapy dose of Casodex."
"Casodex was well tolerated at all doses with no effect on haematological or cardiovascular parameters and no effect on renal function."
"
Casodex has a favourable side effect profile compared with the known safety profiles of other antiandrogens and has demonstrated intrinsic efficacy."
AND A RECENT STUDY:
Expert Opin Drug Saf. 2014 Nov;13(11):1483-99.(from full article)
"Diarrhea has been reported in only 2 – 6% of patients in Bicalutamide monotherapy studies [29-31,43,44] and only isolated cases of elevated liver enzymes were observed [67]. To date,
only one case of Bicalutamide-induced hepatic failure has been reported in the literature [68]. This hepatic failure was attributed to Bicalutamide because of the absence of other etiologic factors, the temporal relation with drug administration and the resolution of hepatitis following drug discontinuation [68]. However, the authors note that the patient was previously treated with Cyproterone and Flutamide and hypothesize that these drugs might have sensitized the patient to Bicalutamide toxicity [68]."
"Interstitial pneumonitis induced by Bicalutamide is
an extremely rare event [69]."
Given the above, I consider this anti-androgen quite safe but as with most non native molecules, there are risks but I find these are very low. I'm sorry you experienced negatives with this drug (were you taking a high dose?) but there is no guarantee nothing will happen. Overall though, the drug seems quite safe.
QuoteThe links I have posted raise concerns. I think you should be much more circumspect in the future about advocating its merits. It is so untested and unused in our MtF world that I want to caution those who read your posts to be careful. I, for instance, had a very nasty reaction to it.
Studies have shown good tolerability in men (also XY), of an
advanced age and stricken with cancer, at
high doses. This is why I personally consider this anti-androgen to be relatively safe for our population. As always though, I repeat, I'm not a doctor.
