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drug_recall androstenedioneAndrostenedione is a synthetic muscle building dietary supplement considered a steroid precursor because it does not covert into a steroid until after being absorbed into the body. Commonly referred to as andro, the FDA has recently banned the supplement from the market because of the serious and irreversible andro effects that can occur. Failing to comply with the FDA''s warning, the drug agency informed the 23 companies it told to immediately stop distribution and marketing of the drugs could have their inventories seized and legal action taken against them.
The dietary supplement industry has been under the spotlight following the December 2003 ephedra ban the FDA announced. When the FDA issued the warning letter to 23 andro manufacturers, the agency cited a rarely used provision of federal drug law requiring dietary ingredients that were introduced after 1994 to be certified by the government and be deemed safe prior to its marketing. Due to the dangerous andro effects, officials have said it would deny certification, even though the agency never received requests from its manufacturers for safety.
Andro sales took off in 1998 after Mark McGwire broke the single season home run record and exposed he had used andro. Soon, sales of andro supplements increased to $25 million, topping off at $55 million in 2001. Sales of andro products have declined in present years as more people become aware of the serious andro effects. There were still sales of $15 million for andro products in 2003 despite the realization that the andro effects could become permanent, especially dangerous when children and adolescents use them.
Major league baseball has been highly criticized for its failure to join other professional sports leagues and ban the use of andro. Impressionable children and adolescents that are the most vulnerable to suffering serious andro effects will continue to seek a "shortcut" to excel in their sports, especially if knowing their favorite sports players are using the supplement, many argue. According to the government''s most recent figures on andro use by adolescents, finding suggest 2% of high school sophomores and 2.5% of high school senior used andro products in 2001.
The andro effects on children and adolescents can cause considerable disruptions in their development. The way that andro effects can be viewed is the premature puberty that can be induced with its use. When this occurs, a closure of the growth plates of long bones can result in a diminished adult stature ever being reached. Normal sexual development is sometimes interrupted due to andro effects.
Excessive doses of the supplement can lead to feminization of boys and men and masculinity of girls and women. For example, the andro effects in boys and men can include enlarged breasts and testicular atrophy and in girls and women can include male pattern baldness, excessive facial hair and deepened voices. The FDA action was seen as a necessary first step to ensuring the safety of consumers, but not adequate enough since andro can still be found at gyms, health stores, on the Internet, as well as other places. The drug agency has said it is still evaluating whether or not to pursue enforcement action against those particular manufacturers and distributors.