From The Medical Republic, 1 October 2021
When did you last read a study of a new drug or treatment which included any mention of – or even ruled out – potential adverse effects impacts on male fertility?
If you’ve been racking your brain for several minutes and still can’t think of one, you’re not alone. Surprisingly, given the inescapable biological fact that it requires both a male and female to contribute to a successful fertilisation event, male fertility is not even an afterthought in the vast majority of clinical trials of new medical therapies.
But this issue is currently on the radar, after the US Food and Drug Administration declined to approve oral JAK-1 inhibitor filgotinib for rheumatoid arthritis because of concerns about potential effects on sperm counts. Manufacturer Gilead then withdrew its application for approval not just in the US but in Australia as well, even before it had released the results of a study designed to investigate this exact issue (and which didn’t appear to show an effect compared to placebo. Read more.