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Testosterone Products Getting Increased FDA Scrutiny

Recent report finds 30% increased risk of death, heart attack and stroke among men taking testosterone products, the FDA takes action.

FDA Panel Says Testosterone Drugs Need More Study and Reduced Use

Getty Images[/caption] In a move that may dampen the sale of testosterone treatments, an FDA advisory panel yesterday recommended that drug makers study the risk of heart attacks associated with these widely advertised products. And the panel also wants prescribing information to include language that the drugs have not been proven to reverse common effects of aging, such as low libido, fatigue and muscle loss. The recommendations came amid mounting controversy over cardiovascular safety and allegations of inappropriate marketing of drugs that were used by an estimated 2.3 million American men last year. Usage, in fact, nearly doubled from 2010 to 2013 and about 21% of men who take these drugs did not have lab work to indicate treatment was needed, according to an analysis by FDA medical reviewers (see the briefing documents). Over the last several years, the marketing for various testosterone treatments - such as AndroGel, which is sold by AbbVie has warned that low testosterone can interfere with sex drive, moods and energy levels. But the increased usage was accompanied by a growing number of studies that indicated the drugs could increase cardiovascular risks, although other studies suggested otherwise. Consequently, testosterone treatments became the latest flashpoint in an ongoing debate over the veracity of pharmaceutical marketing. "Why did the FDA allow this huge push for the creation and selling of aging is optional for men, when we don't know the benefits or harms?" Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice told The New York Times. One recent study found a 30% increased risk of death, heart attack and stroke among men taking testosterone compared with those who did not. Another reported a two-fold increase in the risk of a heart attack among men aged 65 years and old in the 90 days following a first prescription. Among men younger than 65 years old with a preexisting history of heart disease, there was a two to three-fold increased risk of a heart attack in the  90 days following a first prescription. "There's no way testosterone would be approved for the treatment of age-related low-T today by contemporary regulatory standards," John Teerlink, an FDA panel member and heart specialist at the University of California, San Francisco, told the Associated Press. "We have no evidence of any benefit for patients and we have questions about clinical safety." The AndroGel testosterone treatment has been a big seller for AbbVie. Last year, the product generated slightly more than $1 billion in sales. Lilly does not break out sales for its Axiron treatment, while Testim gained $271 million in sales for Auxilium Pharmaceuticals, according to Bloomberg News. To what extent the panel recommendations will alter prescribing remains to be seen. For one thing, the FDA must still decide whether to follow the recommendations. Even if the agency were to do so, physicians are free to prescribe the treatments as they see fit. So marketing to consumers, of course, will continue to play an important role. AbbVie, however, halted AndroGel advertising this summer. An AbbVie spokeswoman sent us this note: "AbbVie is committed to our patients and we will work with the FDA during its review." A Lilly spokeswoman wrote us that the drug maker is conducting a study in 600 hypogonadal men to evaluate potential benefits and safety of testosterone. Results are expected early in the second quarter of 2015. Lilly will also talk to the FDA about reassessing labeling, given its trial. We asked Auxillium for a reply and will update you accordingly. It is worth noting that, earlier this year, Health Canada asked drug makers to update the product labeling for their drugs after the regulator found evidence from published studies and case reports for the risk of heart attacks and other serious reactions. Originally posted by By Ed Silverman on the Wall Street Journal Pharmalot blog. Testosterone Products - Ball & Bonholtzer Trial Lawyers - Pasadena Law

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