Shortly after the FDA announced last month that they were investigating the safety of testosterone therapy drugs five men filed claims against an Abbott Labratories subsidiary AbbVie, the manufacturer of the popular AndroGel. Three of the men claimed they had heart attacks and two had strokes after they began taking AndroGel.
Another case was recently filed in California federal court in which a male patient alleges he suffered a stroke after taking the testosterone therapy drug Testim.
In recent years drug companies have heavily promoted testosterone replacement drugs as a product that can overcome a supposed disease called “low T.” According to the marketing low T is characterized by feelings of fatigue, loss of sexual drive, depressed moods, an increase in body fat and decrease in muscle strength, among other symptoms – all common problems associated with aging. As a result of this aggressive marketing American men have resorted to testosterone drugs as lifestyle drugs out of simple reluctance to accept the fact that they are getting older .
The FDA alert FD said it was investigating the risk of stroke, heart attack and death in men taking testosterone drugs based on the recent publication of two studies that suggested increased cardiac risk.
The consumer advocacy group Public Citizen has gone even further and petitioned the U.S. Food and Drug Administration to add a black box warning, the most serious possible, to the product labels of the drugs. Their petition was based on the growing body of evidence of the risks of heart attacks and other cardiac dangers from studies dating back to 2010 and a recently published analysis of 27 studies going back as far as 20 years. According to Public Citizen, of the 27 studies, 14 that were not funded by the pharmaceutical industry showed a “highly significant” increased risk,. Drug companies funded thirteen and those studies showed no increased cardiovascular risk.
Bowing to pressure the FDA has soft pedaled the alert and said it has not concluded that testosterone does, in fact, increase heart problems. A senior adviser at Public Citizen’s health group, Dr. Sidney Wolfe, claims the the FDA’s statement is “reckless” and “a betrayal of the FDA’s role as an agency in the U.S. Public Health Service.”treatment increases the risks of cardiovascular diseases, including heart attacks,” he said.
In spite of this evidence, each day almost 13,000 prescriptions are filled for testosterone replacement drugs. In 2012, more than 5.5 million men filled prescriptions for low-T drugs like AndroGel, Axiron, Testim and AndroDerm. AbbVie Inc’s AndroGel, the market leader, generated about $1.2 billion in sales.
With that kind of money at stake it is not surprising that drug companies willcontinue to promote the fake disease “Low T”, and market these dangerous drugs as a cure. Your health is a only secondary concern to their bottom line.