Balding Blog

You have mentioned that Avodart is not yet approved by FDA. Do you know what the status is on them approving it? Is it in its beginning trial stages or are the trials mostly complete and the FDA is just evaluating all of the research before making a decision. Or have they rejected it all together?

Avodart was approved by the FDA for treatment of benign prostatic hyperplasia (BPH), in 2001. While I do not know which stage the trials are currently in, I am sure that the manufacturer of Avodart is doing all they can to speed up the FDA approval process for use in hair loss, if it is even at trials to begin with.

A BaldingBlog reader named Greg originally posted this as a comment to a blog entry, but I’ve formatted it to make it easier to read and have reposted it here.

The FDA has found Avodart to be safe (for BHP). The side effects were very simliar if not a tad less then Proscar 5mg, which also was cleared by the FDA many years ago. I think Avodart should be indicated as a off label prescription in some instances.

1. non-responders to Propecia
2. When the loss of efficacy of Propecia becomes bothersome to a indivdual

One other interesting point is that the age group the FDA studied on Propecia (18-42) was quite younger than what Proscar/Avodart (50+ median age 66 approx) so the chances of sexual side effects will inherently be larger in this age demographic as opposed to Propecia… meaning the side effects are probably even closer then one thinks/ Propecia versus Avodart. The one draw back with Avodart is that there is no “human model” with type 1 suppression so there is a question on “long term” safety as with many drugs. As long as you dont have any side effects with Avodart, the long half life can only be beneficial with Androgentic Alopecia and the phase 2 studies show this. People held onto the hair they gained (even grew more) 12 weeks “after” the the medication was discontinued (0.5 mg/ 2.5 mg only). Proscar users saw a sharp decline in this time frame. I hope these facts are helpful in some way.

Thank you for your insight. I believe that what you said makes good sense. I would hope that I could adopt a similar view in an ethical/legal framework.

Dear Sir .. I am suffering from severe hair loss since last one year.

Recently my doctor prescribe me the Dutasteride (Avodart) Medication for hair loss prevention. I continued the medication for 10 days and then I started to get severe Abdominal Muscle Cramps. After I stopped taking this medication the pain subsided slowly. I have recently read the article about Prostaglandin D2 protein and baldness on some website. Wanted to know that the Dutasteride is the cure for Prostaglandin D2.

Now I am confused that should I continue the Avodart medication or should I discontinue it permanently. I want my hair so I wanted to have your help, If you can prescribe me a good medication for hair loss prevention and regrowth .. So that I can discuss your prescription with my doctor.

Will be thankful for your reply and suggestions.

Regards

First things first — Avodart (dutasteride) is not approved for treating androgenic alopecia, and I don’t know what dose you’re even taking. I’ve read internet reports of abdominal cramping for some users upon starting Avodart, but I don’t really have much info beyond that. With respect to taking a prescription medication, you need to discuss these issues with the doctor that prescribed you the medication, especially if you feel you are having side effects!

As far as I am aware, dutasteride has no correlation with prostaglandin D2.

Hi.DR.RASSMAN, I would like to know if type 1 DHT causes hairloss?? or is it just type 2..?? Please let me know when you get a chance… and do you think they will becoming out with anything better then propecia in the near future???

Propecia is a type 2 competitive inhibitor of DHT and Avodart is a competitive inhibitor of both Type 1 and Type 2 receptors. I think that is what you are asking. There is no clear evidence that blocking both Type 1 and type 2 receptors is better. What we do know is the Avodart does drop the DHT level in the blood stream more effectively than Finasteride (90% vs 75%). What this means is suggestive that it might work better in some people. But I must state clearly that safety and effectiveness is the mainstay of the FDA and until we have a handle on these two issues, I believe it is better to stick to Finasteride.

I would like to know what you found out in regards to Avodart at the hairloss convention. Please get back to me when you get a chance.

There is a strong suggestion that Avodart will work better than Propecia from what I heard at the meeting. There are, however, many questions not answered such as:

1. What is the appropriate dose considering that there is a half life of 6 weeks for the medication in your body? Nobody seems to have a good answer to this question.
2. Some think that Avodart may stay in the tissues for over 6 months, so what effect could this have on your system?
3. What is the long term safety of Avodart taken by young man? All of the documented studies are on men over 50 (old-‘farts’ like me)

These are the reasons that most doctors do not want to prescribe Avodart ‘off label’ (not FDA approved for hair loss treatment). From a medical-legal point of view, as well as a licensing issue, I can not really prescribe it. Also, my expertise is in surgery, not medications (although I try to use medications I command and know forward and backward). There are some dermatologists, internists, urologists and family doctors that would prescribe this medication, and if you want to go that route, you should try to find one of them to prescribe it for you. With an off-label use, the issues of safety are risks that you must take.

The preliminary studies that were presented indicate that it works to grow hair when Propecia fails to do so. Still, Propecia should be the first line for the medical treatment of hair loss. What does concern many doctors, however, is that there may be a Vioxx type of hidden side effect in the young man that is not known. Will it produce cancers or heart disease or some other problem that is not yet identified? This is the reason we look to the FDA, to define safety and effectiveness for us. So far, the safety is not clear and the effectiveness appears to be coming into view through unofficial channels.