The FDA has zoomed in on testosterone products for the cardiovascular risks they might pose to consumers, even slapping a new warning on their official labels. Now, the agency has called a special advisory committee meeting to probe two trials that flagged an increased risk of heart attack in men using the meds.
On Sept. 17, the FDA's Bone, Reproductive and Urologic Drugs panel will sit down with the Drug Safety and Risk Management committee to weigh the risk of heart attack associated with testosterone drugs. They'll have plenty to review; the safety meeting follows months of investigation by the FDA, which "decided to reassess" testosterone products in light of the two new studies. Just last month, the agency slapped a new warning about blood-clot risks onto the drugs' official labels.
And the stakes are high: The testosterone market amounts to $1.6 billion, and is expected to grow to $5 billion by 2017. Partly inspired by a "Low T" advertising push, men have been scrambling to supplement low testosterone counts--technically known as hypogonadism--with products that may increase sex drive, improve mood and strengthen muscle tone.
After the all-day safety session, the advisory committees will reconvene the next day to consider a potential new competitor in that market, Rextoro (undecanoate), from Northbrook, IL-based Clarus Therapeutics. Getting the green light won't be an easy task, given the safety questions hanging over the class.
The FDA isn't the only threat to testosterone drug manufacturers. A panel of judges in Chicago consolidated a number of mounting cases against Abbott ($ABT) and AbbVie ($ABBV), which sell AndroGel; Eli Lilly ($LLY), which makes the armpit swipe Axiron; Pfizer ($PFE), for its injectable version; and Actavis ($ACT) for its testosterone patch.
But there might be some light at the end of the tunnel for drugmakers. Earlier this month, a University of Texas study on 24,000 Medicare patients found no cardiovascular risk associated with the drugs.
- here is the FDA advisory committees' notice