Abbott’s new testosterone test gets FDA clearance

androgel pump 435x435 Abbott’s new testosterone test gets FDA clearance  The U.S. Food and Drug Administration (FDA) has approved a new method of analyzing testosterone levels in men and women. The new chemical analysis is made by Abbott Laboratories, the drug maker whose sales of Androgel testosterone-replacement gel achieved blockbuster status in recent months, earning the company nearly $900 million in 2011.

According to Abbott, its new testosterone assay should help doctors more accurately measure testosterone levels, which vary widely in both men and women. Abbot reported on its website that published studies have demonstrated that many testosterone tests currently used are not sufficiently sensitive to accurately measure low testosterone levels, thereby limiting the clinical usefulness of the tests.

“The ARCHITECT 2nd Generation Testosterone Assay is more sensitive, accurate and precise than previous versions of the assay,” said Frank Quinn, director of Global Scientific Affairs for Endocrinology at Abbott in a company statement. “The improved assay performance means physicians will be able to obtain more reliable measurements of testosterone and use this information to help guide patient treatment decisions.”

Abbott’s new testosterone test should be a nice addition to its rapidly expanding testosterone empire. Analysts expect sales of Androgel and other testosterone drugs, such as Auxilium’s Testim, to triple within the next five years, bringing in annual sales of $5 billion.

Androgel 1% was approved in 2000. The FDA approved Abbott’s more potent 1.62% formula in April 2011. By the second quarter of 2012, the drug had earned Abbott $230 million. It is currently the 37th most prescribed drug in the U.S.

Although Androgel may help men with pathologically low testosterone levels, the drug could spell trouble for others, even those who don’t use it. For instance, the drug is designed to be used on the upper arm or shoulder, areas that typically are shielded by clothing. However, women and children may experience the effects of secondary exposure by coming into contact with the user’s skin, clothing, or other personal articles.

Unexpected sexual development, including enlargement of the genitals, may occur in children exposed to Androgel and other testosterone drugs. Premature development of pubic hair, increased erections, aggressive behavior, acne, and advanced bone age are other adverse effects children may develop after being exposed to testosterone-replacement drugs. The U.S. Food and Drug Administration has received reports of premature puberty in children from 9 months to 7 years old linked to secondary exposure to testosterone gel.

Women exposed to the drugs may experience changes in hair distribution, an increase in acne, and other signs of excessive testosterone. As the number of prescriptions for testosterone drugs climbs steadily, the number of women and children at risk of secondary exposure will almost certainly soar.


U.S. Food and Drug Administration