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drug_recall androstenedioneOn March 11, 2004, the FDA announced it was cracking down on companies that were manufacturing, marketing, and distributing products containing androstenedione. The drug agency sent letters to 23 companies, warning possible product seizure and fines could be faced should there be a failure to immediately comply with ending distribution of androstenedione containing products. While the androstenedione ban is seen as a positive step in eliminating serious heath problems, there are still problems that need to be addressed.
The FDA''s androstenedione ban was the result of consumer concern and research showing the dangerous effects. The drug agency had concluded there was inadequate information showing supplements containing androstenedione could be expected to be safe. Known as a steroid precursor, androstenedione is converted into a steroid after absorption into the body.
While androstenedione is naturally produced in very small amounts in the adrenal glands, ovaries, and testicles to be converted into testosterone, synthetic forms of androstenedione acts like an anabolic steroid. Anabolic steroids induce muscle growth, which androstenedione has been marketed for, as well as to enhance athletic performance. In 1998, after St. Louis Cardinal Mark McGwire broke the major league record for home runs and acknowledged his use of androstenedione, sales of androstenedione took off.
After McGwire revealed his use of androstenedione, the sales of the supplement took off to $25 million in 1998. In 2001, sales of androstenedione products topped at $55 million but have since dropped in sales as androstenedione side effects have been revealed. Dangers of suffering serious androstenedione side effects are especially high among children and adolescents using the products.
Studies have indicated using androstenedione increases the production of the hormones testosterone and estrogen. The irreversible effects in children and adolescents using androstenedione can be very disruptive to their development. Disruption of normal sexual development, sever acne in girls, excessive body and facial hair, deepening of the voice, permanent enlargement of the clitoris, menstrual cycle disruption, and infertility can all be suffered. Since androstenedione can set off premature puberty, there can be early closure of growth plates of long bones that can forever stunt their adult size.
The androstenedione ban is definitely considered an important step, but critics are quick to point out androstenedione can still be found at health stores, gyms, and on the Internet. According to a 2002 Health and Human Services (HHS) survey tracking drug use among students, one out of every 50 tenth grader had taken androstenedione in the previous year. The latest government figures show about 2% of high school sophomores use androstenedione products.
The HHS Secretary Tommy Thompson encouraged Congress to pass legislation that is co-sponsored by Sens. Orrin Hatch and Joe Bidden to classify androstenedione containing products as a controlled substance. By doing this, the Drug Enforcement Agency would be able to regulate androstenedione under the Controlled Substances Act. Many are hoping that the publicity androstenedione is getting in the aftermath of the FDA ban, in addition to the acknowledgement of its use among top athletes, will help the bill get a hearing soon.
FDA.com - Health effects, background information and dangers of
Androstenedione.