Concerns about high dose biotin and risks of infertility?

Biotin is an emerging therapy for the treatment of secondary progressive MS.

Concerns about high dose biotin and risks of infertility?

Postby SPMS46 » Thu Nov 02, 2017 7:44 am

Hello MS community,

I am a 46-year-old male with SPMS who is eligible for the MD1003 study. My main concern and my partner is on the male reproductive system after reading this study on rats, Dietary intake of high-dose biotin inhibits spermatogenesis in young rats:

http://onlinelibrary.wiley.com/doi/10.1 ... 0-bib-0041

I note this is a study on young rats, not male adults with a developed reproductive system but the conclusion is worth noting:

In conclusion, this is the first study to show that dietary high-dose biotin intake affected reproduction in males and inhibited the maturation of spermatogenic cells. We selected a high-dose of biotin because the purpose of this study was to characterize a new function of biotin in reproduction in males. However, the results of the present study were obtained from a limited number of rats. Therefore, further studies are needed using a larger number of animals and other species. A high dietary dose of biotin may lead to some adverse effects in humans; however, the dose used in the present study was too large to determine the No observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL), and setting UL for biotin may be important for preventing such dietary biotin-induced adverse effects. Therefore, more definitive experiments are required before setting UL for biotin.


The company’s medical monitor reinforced that contraception must be used while in the study. Aside from that, she mentioned that the possibility of this cannot be ruled out, but it is unlikely to affect sperm production. But if it's so safe, why do I need to use contraception? Also, this means I cannot have a child while on the drug.

I wonder if any people in France had issues with fertility after starting this form of high-dose biotin since I am told over 5000 patients are on it there.

I am currently weighing the pros and cons very carefully and in the meantime, taking high dose Alpha Lipoic Acid (1200 mg a day) along with 10,000 IUs of vitamin D a day.

Apart from contraception and safety, my issue is I've been through many disappointing studies and even though the results look promising, the sample size is too small and I don't know if the risks are worth it, especially since I might be taking a placebo (50% chance).

My MS is stable, it has progressed very slowly, cannot walk far without taking breaks but I am otherwise fine. My biggest issue is spasticity in legs and lower back pain which I just found out that botox injections might help.

Any advice here is welcome, thank you!
Last edited by SPMS46 on Fri Nov 03, 2017 7:34 am, edited 1 time in total.
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Re: Concerns about high dose biotin and male reproduction?

Postby SPMS46 » Thu Nov 02, 2017 9:39 am

I received more information:

The medical monitor indicated that conventional studies of genotoxicity, reproduction and development revealed no genotoxic potential of MD1003; and no toxic potential of MD1003 for reproduction and development in adult rats at doses up to 1000 mg/kg/day.

Biotin administered by daily gavage (30 mg/kg/day) to pregnant rats was shown to be teratogenic, however; and a non-GLP study in rats indicated that biotin inhibits spermatogenesis in young rats.

Contraception is standard in most studies as a precautionary method.
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Re: Concerns about high dose biotin and male reproduction?

Postby SPMS46 » Fri Nov 03, 2017 6:21 am

Just to let you know, I decided not to partake in this study. It was a personal decision and to be frank, I wasn't convinced it was worth the hassle of wearing a fitbit watch all the time and doing a bunch of tests all over again and risk being on the placebo. I will monitor the results closely but right now, I am fine sitting this one out. Be informed, don't jump into anything if you are not comfortable.
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Re: Concerns about high dose biotin and male reproduction?

Postby SPMS46 » Fri Nov 03, 2017 7:29 am

There is something else that bugged me about this study. I had to take one pill every four hours one hour before every meal or two hours after like clockwork. Visits every six weeks, MRIs every three months, an independent assessor, wearing that fitbit watch all the time, and just way too much time to risk being on placebo and going through the aggravation. They didn't really fully explain the risks to me, so I decided it's not worth my time and aggravation. Can't they do this with ONE pill a day and make it A LOT easier for patients with SPMS????

Many of these companies are clueless!!! They think patients are desperate, uninformed CHUMPS!!!

(Ok, end of my rant, hope this helps you make informed choices)
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