The FDA has dealt a blow to the $1.6 billion testosterone supplement market, which includes the top-selling AndroGel, made by Abbott Laboratories' ($ABT) recent spinoff, AbbVie ($ABBV). The drug labels must now include a general warning about the risk of blood clots in veins.
The agency decided on June 20 that the warning on testosterone products must be more "general" to "ensure this risk is described consistently." Postmarket reports of blood clots prompted the FDA to take action, it said. Testosterone products already carry a warning about the risk of clots that are related to a condition called polycythemia, an abnormal increase in red blood cells.
Although beleaguered by critics, the market for testosterone products has grown rapidly as men scramble to supplement low testosterone count--or "Low T"--with products that may increase sex drive and muscle tone. The FDA has pointed out that the drugs are only approved to treat specific low testosterone conditions, such as depletion as a result of chemotherapy or deficiency from genetic problems. But IMS Health expects the testosterone market to hit $5 billion by 2017.
In January, the FDA said it has been monitoring the stroke and heart risks posed by testosterone products but in light of two recent studies has "decided to reassess this safety issue," prompting an investigation. Critics have slammed this newest review for taking so long: Sidney Wolfe, co-founder of advocacy group Public Citizen, wrote in a February petition that the FDA's previous stance was "reckless."
The European Medicines Agency began an investigation into the cardiovascular risks posed by Low-T drugs in April and will issue an opinion on whether to maintain, alter, suspend or withdraw marketing authorization on the drugs across the EU.
The newest FDA weigh-in comes hot on the heels of mounting legal actions against testosterone product manufacturers. A panel of judges in Chicago decided earlier this month to consolidate the cases against not only Abbott and AbbVie, but also Eli Lilly ($LLY), which makes the underarm testosterone treatment Axiron, Pfizer ($PFE) for its injectable version of the hormone and Actavis ($ACT) for its testosterone patch.
- here's the FDA warning on drug safety