According to its manufacturer, AbbVie, “AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone.” The AndroGel website offers the following ten question yes-no quiz to see whether a man “should talk to” his “doctor about Low Testosterone:”
- Do you have a decrease in libido (sex drive)?
- Do you have a lack of energy?
- Do you have a decrease in strength and/or endurance?
- Have you lost height?
- Have you noticed a decrease in your enjoyment of life?
- Are you sad and/or grumpy?
- Are your erections less strong?
- Have you noticed a recent deterioration in your ability to play sports?
- Are you falling asleep after dinner?
- Has there been a recent deterioration in your work performance?
The ten questions might just as well ask, “Are you getting old?” or “Are you naturally aging?” Snake oil salesmen have been selling fountain of youth elixirs since people starting getting old. Fortunately, most snake oils are only harmful to the purchaser’s wallet as many of the alleged aging cures are harmless. However, once in a while a potion does contain harmful ingredients or actual medicinal compounds which have major physiological effects. AndroGel seems to be promoted as the cure for a newly discovered disease called, “Low T.” However, its safety is in question.
On January 31, 2014, the United States Food and Drug Administration (FDA) issued a Safety Announcement regarding testosterone products. This communication stated, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.” While the beginning of this Safety Announcement might not seem alarming, the FDA further states, “None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.”
What is “an associated medical condition?” The manufacturer of AndroGel would have one believe that Low T (the condition of having low testosterone levels) is an associated medical condition to the condition of having low testosterone. If you think this is strange logic, you would be correct. There are some who feel that the manufacturer of AndroGel, realizing that it had a profitable “cure” for a disease that did not exist, simply invented a disease with ten associated symptoms (see quiz above). Recent studies have shown that certain groups of men taking testosterone will have increased risks of stroke and heart attack. Lawsuits are now being filed against the manufacturers of AndroGel and other testosterone products for failing to warn consumers about the deadly harm that testosterone can cause. Without getting technical, testosterone has been shown to increase the red blood count (thickening of the blood) which can cause clotting issues leading to stroke and heart attack.
If your physician has prescribed AndroGel for you, you should immediately discuss whether you truly need it and whether there are safer alternative drugs. After weighing the risks and benefits, you and your physician can determine what drug, if any, is best for you. If you or a loved one live in California, have taken AndroGel, and have suffered a stroke, you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from the manufacturer of this drug. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.