The FDA said last week it was going to investigate the heart and stroke dangers that recent studies suggest are tied to use of testosterone-enhancing drugs. Five days later, 5 lawsuits were filed against Abbott Laboratories ($ABT) and its spinoff AbbVie ($ABBV) by men who claimed they suffered heart attacks or strokes after using one of those products, AndroGel.
According to Bloomberg, three of the men say they had heart attacks after they started using AndroGel, one said he had a stroke and one claimed to have suffered a "ministroke." Their ages ranged from 50 to 63. Abbott declined to comment and the news service was unable to reach an AbbVie spokesperson.
The FDA said last week it has been monitoring the stroke and heart risks but in light of two recent studies "decided to reassess this safety issue." In November, a study published in the Journal of the American Medical Association found that using testosterone increased the risk of death from heart attack or stroke by 29% in men with or without a history of heart disease. The FDA said another study has found an increased risk of death among both younger and older men with preexisting heart disease. The agency pointed out that it has only approved the drugs for men who lack testosterone or whose low levels are related to a medical condition.
The drugs are not approved simply to treat "low T," and that is where much of the growth in the market has sprung. IMS Health says by 2017, the entire testosterone market is expected to hit $5 billion, up from less than $2 billion in 2011. Products in the category include Eli Lilly's ($LLY) Axiron and Testim from Auxilium ($AUXL) and GlaxoSmithKline ($GSK), in addition to AbbVie's AndroGel. According to AbbVie's earnings, reported last week, sales of AndroGel actually shrank 10.1% to $1.035 billion last year.
But concerns over that growth have been building. Consumer Reports magazine weighed in on the issue last year, urging men to think twice before starting on testosterone therapy. It pointed to risks that include enlarged prostate or breasts, and sleep apnea, as well as heart and blood clot risks. Dr. John Santa with the magazine said most men don't need the drugs.
The recent lawsuits, filed by either Simmons Browder Gianaris Angelides & Barnerd in Illinois or Morelli Alters Ratner in New York, name only AndroGel and Abbott and AbbVie, which got the drug when it was spun off from Abbott the first of last year. The suits allege that the companies deceived potential users about the need for the drugs and about their possible risks, in part by using "testimonials from retired professional athletes," Bloomberg reported.
- read the Bloomberg story