The FDA has been reviewing testosterone drugs since January of this year on concerns over their cardiovascular safety. Now, its across-the-pond counterpart is following suit, embarking on its own review following worrisome study data.
The European Medicines Agency (EMA) will take a look at so-called Low-T drugs now that studies have suggested the products may come with heart risks, the agency said Friday. After it compares the risks and benefits, it will issue an opinion on whether to maintain, alter, suspend or withdraw marketing authorization on the drugs across the EU.
This newest review comes at a controversial time for Low-T drugs, whose critics have slammed the FDA for taking its time to weigh the issue. "It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks," Sidney Wolfe, founder of advocacy group Public Citizen, wrote in a February petition that labeled the agency's current stance "reckless."
According to the EMA, one study suggested that taking testosterone ups the risk of heart attack in men older than 65 and in younger men with heart disease, and the regulator says other studies have produced similar concerns. Research cited by the FDA found an increased risk of death among both younger and older men with preexisting heart disease, prompting activists to push for the addition of black-box warnings on the drugs.
Any limitations on testosterone drug use could have big implications for companies like Eli Lilly ($LLY), AbbVie ($ABBV) and Auxilium, whose products have helped grow the market by 90% in 5 years to reach $1.9 billion in 2011. And it's not stopping: By 2017, IMS Health expects the entire Low-T market to hit $5 billion.
But there are fervent critics on the other side, too. Physicians and researchers are calling for the retraction of one paper, published last November in the Journal of the American Medical Association (JAMA), that helped prompt the FDA's review. JAMA has since published two corrections to the study, which linked testosterone therapy to a greater risk of death, heart attack and stroke in some patients; those corrections compromise its credibility, a study group says.
- read the release
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