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FDA Investigating Risk of Heart Attack with Testosterone Therapy Treatment

5 comments

On January 31st, 2014 the U.S. Food and Drug Administration announced plans to investigate the risk of heart attack, stroke and death in men taking different forms of testosterone therapy treatments. This announcement follows two recent studies, one published in PLOS One.

The FDA made it clear that testosterone products are approved “only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.” These might include problems with the production of testosterone due to genetics, chemotherapy or brain function.

Why Testosterone Therapy?

As the FDA pointed out, there are many causes of low testosterone in a man’s body, including a natural decline of testosterone as a man gets older. Some symptoms of low testosterone include: erectile dysfunction; difficulties with concentration and memory; mood changes; diminished sense of well-being; and a lower sex drive.

A doctor is required to measure the amount of testosterone in a man’s body. The level of testosterone starts to decline in a man’s body after age 30. There is no guarantee that testosterone therapy will help healthy older men with no other underlying disease contributing to their low testosterone levels. The Mayo Clinic reports that testosterone therapy can help with hypogonadism, which is a disease where the body cannot produce normal amounts of testosterone. This could be the result of a problem with the pituitary gland or the testicles.

Forms of Testosterone Therapy Treatment

Testosterone therapy is available in several forms including topical gels, a transdermal patch, a buccal system which is applied to the inner cheek or upper gum, or an injection.

Perhaps three of the more widely known forms of treatment are Axiron, manufactured by Lilly USA, Inc., Testim, manufactured by Auxillium Pharmaceuticals Inc., and Androgel, by AbbVie, Inc.

Androgel and Testim are sold as topical gels for men with low testosterone. Axiron is marketed as a topical solution. The FDA required the makers of all Androgel and Testim to post black box warnings about the risk of “secondary exposure,” among women and children. The FDA received reports of children showing signs of the early on-set of puberty, while women were developing excess hair growth and an increase of acne. The FDA also warned about “secondary exposure” in those exposed to Axiron.

What’s Next?

If you are on a form of testosterone therapy treatment, do not discontinue using it unless directed to do so by your doctor. In the release, the FDA stated it had not “concluded” that any forms of testosterone treatment therapy increased the risk of patients having a heart attack, stroke, or death. You need to report any side effects to your doctor and to the FDA.

5 Comments

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  1. Tunji says:
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    FDA is late. The risks of testosterone drugs have been known, and the alarm has continuously been sounded since the approval of these class of drugs.

    But heart attack is just one of the risks posed by testosterone drugs.

    Other risks include higher risk of prostate cancer, infertility, sleep problems, liver failure, damage to the fetus in women who come in contact with them, premature onset of puberty in young girls etc.

    In light of these, why would anyone take them?

    Well, men are scared of being less of a man. The ability to perform in bed is a measure of that manhood.
    It is this fear that drug companies are stampeding to monetize

    But what these men have not been told is that a decline of testosterone with age IS normal, but that does not mean a man has to be less vigorous.

    As for young men with erection problems? Most of it due to unhealthy lifestyles, and can be corrected with healthy lifestyle choices

    What testosterone drug should you use?

    NONE!

    The best approach is to give the body what it needs to produce its own free testosterone.

    A man can maintain libido without drugs, IF he takes care of his health-naturally-AND, if he maintains a healthy skepticism of prescription drugs, and their peddlers.

  2. Larry Kramm says:
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    I am 73 and have been on Testosterone injection for 18 years with absolutely no unwanted side effects. The injections cut my insulin requirements in half and gave me an intense desire to exercise and lost 10 inches around the waist, not to mention increased libido. When I was in my early 30’s I couldn’t have any children because of low sperm count. I should have had testosterone injections then but it didn’t exist. I’ve had hypogonadism all my life but didn’t realize it.

    Now a few months ago my health insurance, Kaiser Permenente, stopped giving my testosterone injections. Now I know why. Hysterics like this made be feel absolutely awful. Insulin requirements when way up, A1c levels went up. Difficulties with concentration and mood. Had to go outside Kaiser to and independent doctor and pay cash for the Testosterone support I needed. I feel much better now.

  3. Tony Miller says:
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    I have been on androgel therapy for about ten years myself and I agree the FDA is slow administering findings, so I am concerned when
    told that there is a 30% increase in the chances of Heart attack, Stroke or cancer.
    The FDA needs to step up.

  4. Caleb says:
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    If you do experience any side-effects you need to call your doctor and the FDA. In some cases you should contact your lawyer as well.

  5. Mark Pearce says:
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    I have been using testosterone for several years and recently I stopped giving myself injections, 6 weeks later I feel like crap, my wife came up to me and ask “whats the matter honey don’t you love me anymore?” due to my lack of interest in sex. I felt really bad and overall just plain depressed. I gave myself my normal injection of testosterone a week ago and I’m back to my normal self :-) my wife is happy too! all the people whining about “T” please shut up!