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The FDA is now re-examining the safety of testosterone replacement treatments after two studies showed a higher risk of heart attack risk and strokes in men who use them. The lawsuits claim that the men who used testosterone treatments were deceived by a marketing campaign that underplayed the risks despite the fact that the manufacturers have known the risks.
What are Testosterone Treatments?
The number of testosterone prescriptions given to American men has tripled since 2001. Used clinically since 1937 and approved by the FDA since 1953, testosterone is now administered in at least five forms, including patches, gels and injections.
Testosterone treatments have long been used to treat the medical condition known as hypogonadism in which the body does not produce enough testosterone. Hypogonadism is tested through the blood – where the doctor can measure how much blood freely flows through the bloodstream. This measures the patient’s hormone levels and allows the doctor to rule out other conditions. It is estimated that up to one quarter of the testosterone treatment prescriptions are dispensed without a blood test, much less re-testing for confirmation and adjusting the dose after prescription.
Do you have a decrease in sex drive? Lack of energy? Decrease in strength and/or endurance? Loss in height? Have you noticed a decrease in your enjoyment in life? Are you sad or grumpy? Are your erections less strong?
If you answered yes to ANY ONE of those questions, then the manufacturers of Testosterone Replacement gels advice you to see a doctor to see if you have “Low T”. Well-produced Ads show 50-something men who claim to be “back in the swing of things” after using the gel. These marketing materials do not carry the warning of increased risk of heart attack.
Critics now question this marketing tactic and recent articles warn “Don’t ask your doctor about ‘Low T’”. Testosterone has always declined naturally by age, but men’s average testosterone levels have been dropping by at least 1 percent a year, according to a 2006 study in The Journal of Clinical Endocrinology and Metabolism. The reasons for this decline seem to be tied to drugs like steroids, an increase in weight, chemicals like bishpenol A (BPA) that is found in plastic food containers and diseases like Type 2 diabetes.
So should you treat this natural decline? Is this a new condition? “Low T,” as this condition has been labeled by the testosterone replacement manufacturers, isn’t nearly as common as they would have you believe. Pharmaceutical companies have seized on the decline in testosterone levels as pathological and applicable to every man.
Look at this quiz again…man or woman, obese or not, depending on the day, isn’t it likely that you will answer “yes” to at least one of those questions? Pharmaceutical companies aim to convince men that common effects of aging like slowing down a bit and feeling less sexual actually constitutes a new disease and that they need a prescription to cure it.
A Profitable Business
Aggressive marketing of “Low-T” to the public and doctors has resulted in a boon for testosterone treatments manufacturers. Testosterone “gels” represent 89% of the overall $2.1 billion testosterone replacement therapy market. Sales of all testosterone-boosting drugs are projected to hit $5 billion by 2017.
Testosterone gels are applied once daily to intact skin of the shoulders or upper arms. AbbVie’s AndroGel currently accounts for 66% of the prescriptions in the gel market. Following are a list of other gels that are looking to expand with the continued push in the market for the treatment of “Low T:”
Testosterone Treatments Increase Risk of Heart Attack and Stroke
The problem with testosterone treatments is that it doesn’t just give your T levels a boost – it may also increase your risk of heart attack. It can add huge numbers of red blood cells to your bloodstream and shrink your testes. In some men, it increases aggression and irritability. Children who accidentally come in contact with the hormone (because their father applies it topically) can develop unwanted pubic hair and genital changes.
New research has found that testosterone treatments could cause an increased risk of stroke, heart attack or even death. According to studies, men younger than 65 with known hear disease had a two-fold increase in risk of nonfatal heart attack shortly after initiation of testosterone therapy. Older men with a history of heart disease were 30% ore likely to suffer from an adverse event such as a stroke, heart attack or even death.
Testosterone Treatment Lawsuits Filed
Lawsuits have been filed by men who suffered heart attacks and strokes while using testosterone treatments. The FDA is now re-examining the safety of testosterone replacement treatments after two studies showed a higher risk of heart attack risk and strokes in men who use them. The lawsuits claim that the men who used testosterone treatments were deceived by a marketing campaign that underplayed the risks despite the fact that the manufacturers have known the risks.
On January 31, 2013, The FDA announced it is investigating the risk of stroke, heart attack, and death in men taking prescription testosterone drugs. This move was based on the recent studies that suggested an increased risk of heart attacks in men who take testosterone.