FDA Says Low-T Drug Manufacturers Must Warn of Blood Clot Risks
Surely you’ve seen the commercials for “low-t” or low testosterone. If you haven’t, here’s a glimpse:
Clearly, low-t drug manufacturers promise a rejuvenated sex life and the commercials also seem to suggest that you will want to go sailing and walk along the beach. All joking aside, low-t drug treatment has been touted as a panacea for aging men, but it hasn’t been until recently that warnings about possible blood clots from taking low-t drugs have come to the forefront. Naturally, low-t drug manufacturers probably don’t want their potential customers knowing of those sorts of complications, but they may be forced to reveal that information on product packaging if the FDA gets its way.
Low-T Drugs Increase Oxygen-Carrying Cells Contributing to Blood Clots
The primary problem with low-t drugs, the FDA says, is that they abnormally increase oxygen-carrying blood cells in the body. This process is also known as polycythemia and can lead to an increased risk of blood clots in the body. However, the FDA also reported that it had received reports of blood clots from individuals taking low-t drugs that weren’t related to polycythemia. The FDA recently decided that it would require low-t drug manufacturers to place a generic warning on its products of the possibility of blood clots while taking the medications. Reported blood clots include deep vein thrombosis and pulmonary embolism, both of which are dangerous, but the latter being life-threatening in most situations.
FDA Reviews Blood Clotting Risks of Low-T Drugs, Asks Doctors to Consider Risks Over Benefits
The FDA began reviewing other safety-related issues of low-t drugs after the results of a study were released suggesting that they could increase the risk of heart attack. Their review began in February of this year, and is ongoing. The FDA also asked doctors to consider the risks associated with low-t drugs compared to the benefits, and to decide if they are really worth prescribing. Although low-t can affect a man’s ability to perform sexually, testosterone therapy has also been linked to other side effects such as urinary tract infections, acne, and reduced sperm count, not to mention the risk of cardiovascular episodes and blood clotting.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.