The FDA's Stance on Testosterone Replacement Drugs

By Andrew Sullo


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In the past decade, the number of prescriptions issued for testosterone supplements has increased over 500%; it appears that men across the nation believe they have truly found the fountain of youth. As aging occurs, all men will experience at least some of the “symptoms” associated with growing older. Belly fat increases, energy decreases, libido may decrease as can strength and muscle mass. Erectile dysfunction can also occur as men enter their sixties. Testosterone levels peak around age 18, then remain relatively stable until the early thirties. After that, testosterone levels begin to decrease about 1-3% per year. In the past, the issues associated with aging were taken as a matter of course, however as aggressive marketing on the part of testosterone manufacturers has continued to increase, more and more men are reaching for what they believe is an elixir which will turn back the clock. What they may not realize is that there can be some extremely serious side effects associated with testosterone supplements, including adverse cardiovascular issues, stroke and even death.

The FDA Takes a Second Look at Testosterone Supplements

Following the release of one major study regarding testosterone supplements which was reported in the Journal of American Medical Association in November, 2013 (as well as information regarding another testosterone study which was halted mid-trial due to the number of adverse issues) the FDA has stated they will take a harder look at the potential side effects of testosterone supplements. On January 31, 2014, the U.S. Food & Drug Administration announced a safety review of prescription testosterone treatments; while they have not yet concluded testosterone drugs are dangerous, they have advised doctors to carefully perform a risk/benefit assessment prior to prescribing the supplements. Since the FDA announced the review, several lawsuits have been filed in Illinois on behalf of five men who reportedly suffered serious cardiovascular events following the use of prescription testosterone treatments.

Have there been any FDA Adverse Reports on Testosterone?

While the FDA has yet to receive adverse reports associated with testosterone supplements, following the release of the JAMA study it is likely men who have been harmed by a testosterone supplement will begin to come forward. Once the FDA begins receiving adverse reports—and as further studies are done on men taking testosterone supplements—there is the possibility of a recall in the future, or, at the very least, an FDA warning regarding the potential risks associated with testosterone drugs.

The FDA Investigation into Testosterone is still in its Early Stages

Because the FDA is just now beginning its investigation into the risks associated with testosterone supplements, it could be some time before a decision is reached as to whether testosterone manufacturers will be allowed to continue to aggressively market their drug. The JAMA study showed that older men who used testosterone supplements for a period of three years were nearly 30% more likely to have a heart attack, stroke, or even die as compared to similar-aged men who did not use a testosterone supplement. Barring a recall, analysts believe that the sales of testosterone drugs will triple within the next five years. Current sales of testosterone supplements are bringing in between $1.6 and $2 billion dollars yearly.

The Different Types of Testosterone Treatment

Testosterone supplements can be delivered as a gel, cream, patch, pill, injection or implant. Some of the manufacturers of the following brand names of testosterone supplements may end up with lawsuits against them, just as Androgel has:

• AndroDerm comes in the form of a patch or transdermal film, and is manufactured by Actavis, Inc. The patch or film can be placed on the back, abdomen, thighs or arms and is available in two strengths. AndroDerm received FDA approval in 1995.

• Axiron is applied topically to the underarms (like deodorant), is manufactured by Eli Lilly and gained FDA approval in 2010.

• Bio-T-Gel, manufactured by GlaxoSmithKline gained FDA approval in 2012, but is not one of the more commonly prescribed testosterone supplements.

• Delatestryl is delivered as an intramuscular injection which gained FDA approval in 2003 and is manufactured by Savient Pharmaceuticals. The injection must be given every one to four weeks.

• Depo-Testosterone is manufactured by Pfizer, and gained FDA approval in 2003. Interestingly, on the Pfizer website, it states that Depo-Testosterone has been used for more than 30 years for treating men with low levels of testosterone.

• Foresta is a spray gel applied to the thighs daily, which is manufactured by Endo Pharmaceuticals and gained FDA approval in 2010.

• Striant is an oral tablet which contains 30 mg. of testosterone which is released into the mucous membranes of the mouth. Approved by the FDA in 2003, Striant is manufactured by Columbia Laboratories.

• Testim was approved by the FDA in 2002, and is manufactured by Auxilium. Testim is applied to the shoulders daily.

• Testopel is manufactured by Slate Pharmaceuticals and is an implant which is placed under the skin and releases testosterone over a period of three to six months. Although Testopel was developed in the early 1970’s, it did not gain FDA approval until 2008.

Manufacturers of testosterone supplements may have failed to adequately research the potential risks of stroke, heart attack and death resulting from testosterone therapy, particularly among men who already have cardiovascular disease. If you feel that you have been harmed by a testosterone supplement, call the law offices of Sullo & Sullo today.

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