AndroGel - Quality Control Problems???

[stat1951]

I have read some posts (elsewhere, possibly here too?) that have indicated that there have been a lot of complaints about AndroGel's quality control.

Things like packets not containing the levels of compound that they should (on a consistent basis - for example some 5-gram packets only acutally had 4.1 grams of compound) and that some packets might - for example - have correct weight of product (i.e., 5 grams in this example), but only had 40 mg of testosterone instead of the 50 mg that it should have at a 1% solution.

NOTE: These just being examples of quality control problems, not necessarily specific examples of what I read...

Anyone read anything similar? I have noted on another hypogonadism board that there have been a number of dissatisfied users of AndroGel and a number of others who had complaints with AndroGel and felt that their levels were fine with the same quantity of Testim. In fact, of at least one case were the individual was on two 5-gram packets of AndroGel and had to drop back to one 5-gram tube of Testim as levels were too high with the two tubes of Testim.

A couple of posters commented specifically on reading about where testim's transdermal delivery system was more efficient than that used by AndroGel. I know that AndroGel indicates that 10% of their testosterone (in solution in the gel) gets through to the bloodstream. Posters have indicated that Testim is about 30% more efficient (not sure where that figure came from - have actually even read of higher expressions).

(Example: Try Testim instead. It is a gel with 43 % better absorption than Androgel based on free testosterone tests. You will need only one 5 gram vial instead of two packets... http://www.thebody.com/Forums/AIDS/N...t/Q151657.html)

5 grams of AndroGel at 1% testosterone equals 50 mg of testosterone (more than enough, no?), but only 10% gets through to the bloodstream. That's 5 mg. The average (mid 30s???) adult males produces / needs 5 - 10 mg of testosterone daily. So, depending on the individual, 5 grams of AndroGel or 7.5 grams of AndroGel or 10 grams of AndroGel should do the trick. But not if there are quality control problems going on....

By comparison, if Testim has a 13% efficiency ratio then 5 grams of Testim at 1% strength equals 50 grams of testosterone and 6.5 mg getting through to the bloodstream. Two tubes would be 13 mg of testosterone.

Anyone over here have any comparisons of the two products or stories of possible quality control concerns to share? The only thing that I can personally note is that it has seemed that there were times when I open a packet of AndroGel and it doesn't seem to have as much volume of gel in general...

Thanks for any info...

[mranak]

I think that all packets or bottles of Androgel have the same amount of testosterone in a given amount of gel. However, many factors will influence an individuals aborbtion of Androgel or testim. The 10% absorbtion rate is a rough estimate. It varies from person to person and can even change with the same person through time.

[pmgamer18]

Someone posted this like at the Hyp.2 group.
http://www.fda.gov/bbs/topics/ENFORC.../ENF00702.html
I have sent back box's of androgel because the packets were half full or empty. I get my meds. from Medcohealth and they send me in the mail a 90 day supply so being on 10 grams that is 6 boxs for 90 days. I have had to send all 6 box's back the Medcoheath was gaid when Testim came out. I called Androgel they would not talk to me so I made a complant to the FDA so now I am glaid they have to talk to the FDA now.
Phil

[caos]

Originally Posted by pmgamer18

Someone posted this like at the Hyp.2 group.
http://www.fda.gov/bbs/topics/ENFORC.../ENF00702.html
I have sent back box's of androgel because the packets were half full or empty. I get my meds. from Medcohealth and they send me in the mail a 90 day supply so being on 10 grams that is 6 boxs for 90 days. I have had to send all 6 box's back the Medcoheath was gaid when Testim came out. I called Androgel they would not talk to me so I made a complant to the FDA so now I am glaid they have to talk to the FDA now.
Phil

Sorry, but that link is for a recall from 2001 for a single lot. They're through talking to the FDA on that one. Anyone have newer info?

[caos]

Originally Posted by stat1951

- snip -snip

A couple of posters commented specifically on reading about where testim's transdermal delivery system was more efficient than that used by AndroGel. I know that AndroGel indicates that 10% of their testosterone (in solution in the gel) gets through to the bloodstream. Posters have indicated that Testim is about 30% more efficient (not sure where that figure came from - have actually even read of higher expressions).

(Example: Try Testim instead. It is a gel with 43 % better absorption than Androgel based on free testosterone tests. You will need only one 5 gram vial instead of two packets... http://www.thebody.com/Forums/AIDS/N...t/Q151657.html)

-snip -snip

Anyone over here have any comparisons of the two products or stories of possible quality control concerns to share? The only thing that I can personally note is that it has seemed that there were times when I open a packet of AndroGel and it doesn't seem to have as much volume of gel in general...

Thanks for any info...

From the prescribing info for Testim & Androgel:

10g Testim @ day 30 mean level to T 612 (+/- 286) ng/dl
10g Androgel @day 30 mean level of T 792 (+/- 294) ng/dl

5g Testim @ day 30 mean level of T 365 (+/- 187) ng/dl
5g Androgel @day 30 mean level of T 566 (+/- 262) ng/dl

It seems that based on the above Androgel is absorbed more efficiently than Testim. At 10g both have comparable variation among test subjects. At 5g Androgel has higher variation, but even the subject with worst absorption still had higher T levels than the lowest Testim subject.

[SWALE]

This is the first I have heard of any of this. I think Androgel is a fine product. But so is Testim, now that I have worked with it.