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Is April 12, 2004 it for Andro?

It is if the FDA has its way.

The controversy
Side effects of Andro
FAQ's
The Products being banned
The Studies

The FDA has asked manufacturers and distributors of androstenedione to stop selling and manufacturing products that contain androstenedione by April 12, 2004.

They have done limited research on androstenedione supplements and concluded that there is inadequate information to establish that a dietary supplement containing androstenedione will reasonably be expected to be safe.ⁱ

In fact, FDA believes that these products may increase the risk of serious health problems because they are converted in the body to testosterone which is an androgenic and anabolic steroid ⁱⁱ.

Click here to read more about the controversy

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Potential long-term adverse side effects health consequences in men for high dosages of androstenedione include the following:

In Men
• testicular atrophy
• impotence
• Gynecomastia, or breast enlargement.

In Women
• male pattern baldness
• deepening of the voice
• increased facial hair
• enlargement of the clitoris
• abnormal menstrual cycle
• abnormal bleeding, and blood clots.

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FAQ:

Q. The studies all tested products that had over 100mg dosage of androstenedione per single dose, what about products like Andropower, Testrogel, and Testroxin that only have 20mg per single dose?
A. Good question, The Study done on androstenedione where all for higher dosages ranging from 100mg-300mg per single dose. The scientist who did the study concluded that "As stated above, if taken in sufficient doses, Andro products will have anabolic effects." So the question is to define what is a sufficient dose? 20mg of transdermal gel that contains androstenedione should be enough to give you the extra boost, without the negative side effects.

Q. Male breast? Higher estriaol levels? Who wants that? How does Andropower™ combat against the effects of higher estrogen levels?
A. Andropower™ contains a precise formula of 20mg of Androstenedione and 10mg's of Progesterone to combat the possible side effects of increased estrogen levels.

Q. These products have been available for a while, why would the FDA ban them now?
A. Because of safety concerns raised by health professionals on the abuses of androstenedione-containing dietary supplements by people under the age of 18.

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The Studies:

     One 8-week study on 20 healthy males from 19-29 was done on placebo vs. androstenedione 100 mg three times daily during weeks 1,2,4,5,7,8. They studied the effects of androstenedione in 100mg in a single dose on levels of various hormones.

     They found that neither the single mg dosage 100mg dose nor the extended 300mg daily dosage affected the serum levels of testosterone. They found that the Men using the 300 mg dosage daily saw an increase in estradiol and estrone levels by 50%. With the higher daily dosage of 300 mg a day, the androstenedione treatment reduced the HDL-C (good cholesterol) more than the placebo.

Study # 2 Leder et. al. (JAMA 2000; 283: 779-782) treated healthy men aged 20-40 years with androstenedione 100 mg daily (n=15), 300 mg daily (n=14), or nothing (n=13) for 7 days. While there was no effect at the 100 mg daily dose, there was a mean ~35% increase in testosterone in the serum (integrated over 8 hours) at the 300 mg daily dose. Additionally, serum estradiol levels (integrated over 8 hours) were elevated 42% and 128%, respectively at the low and high doses of androstenedione, respectively. Study # 3 Effects in Women: predominant elevations in androgens

Leder et. Al.(JCEM 2002; 87: 5449-5454) studied the effects of single oral doses of androstenedione (10 women each received either 0, 50, or 100 mg) on serum levels of androstenedione and sex steroids in healthy postmenopausal women.

After androstenedione administration, serum levels of estrone over 12 hours were elevated up to ~115% at the 100 mg dose relative to control. Testosterone levels over 12 hours were elevated up to ~450% relative to control at the high androstenedione dose. Estradiol levels were not elevated relative to placebo. The authors speculate that the elevations in testosterone with androstenedione administration in these women could have adverse effects (see below).

Study #4 Kicman et. Al. (Clinical Chemistry, 2003; 49:167-169) studied the effect of a single dose of androstenedione 100 mg on plasma testosterone over 24 hours in 10 healthy young women in a 2-period crossover study.
Plasma testosterone levels integrated over 24 hours were 16-fold greater than control. The authors also noted that the plasma testosterone concentrations observed were "similar to those encountered in abuse of testosterone for anabolic purposes, the peak of the mean concentrations being at the upper end of the reference interval for men ." These authors as well express concern about the potential adverse effects of elevated sex hormone levels in people taking androstenedione.

Research the issue yourself:
www.thomas.loc.gov
Bills:
S Anabolic Steroid Control Act of 2003 (Introduced in Senate)[S.170.IS]
2 . Anabolic Steroid Control Act of 2004 (Introduced in House)[H.R.3866.IH]
3 . Anabolic Steroid Control Act of 2004 (Introduced in Senate)[S.2195.IS]
4 . Office of National Drug Control Policy Reauthorization Act of 2003 (Introduced in Senate)[S.1860.IS]2195 IS Anabolic Steroid Control Act of 2004 (Introduced in Senate) www.fda.gov