Pennsylvania personal injury lawyer, Marion Munley, warns of the FDA investigation of testosterone products due to health risks
The Food and Drug Administration (FDA) recently announced that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone or “low-T” products, including AndroGel. This comes in light of two recent studies that showed higher rates of cardiovascular problems in men taking these drugs.
According to several lawsuits filed in February in Ilinois federal court, Abbot Laboratories, Inc., and AbbVie Inc. downplayed the stroke and heart attack risks associated with testosterone replacement treatment AndroGel.
The two drugmakers have engaged in an extensive advertising campaign about low testosterone, telling consumers that the natural effects of aging in men, such as listlessness and weight gain, were actually symptoms of the condition that could be treated with their products, according to the lawsuits, brought separately by five plaintiffs.
The suits came four days after the FDA announced it was investigating possible increased risks of stroke, heart attack and death in men using testosterone replacement therapies. Testosterone is a hormone essential for the development of male growth and masculine characteristics. Testosterone products, which have been FDA-approved for decades only for use in men who lack or have low testosterone levels in conjunction with medical conditions, don’t currently carry any cardiovascular warnings.
The first publication that prompted FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association (JAMA) in November 2013. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.
In the latest study, published in the journal PLOS ONE and funded by the National Institutes of Health, researchers report that within 90 days, taking the hormone can more than double heart attack risk in men ages 65 and up, as will as nearly triple the risk in younger men with known heart disease.
Treatments for low testosterone are now an estimated $2 billion-a-year industry in the U.S., with up to 25% of prescriptions written without medical providers bothering to do a blood test to check the man’s hormonal levels, according to the New York Times. In addition to the potential health risks, the New York Times also reported that pharmaceutical companies are exposing many men to these increased health risks without providing any benefits, according to a number of medical researchers and industry experts.
Researchers in Texas reported that between 2001 and 20111 testosterone prescriptions for low-T drugs like AndroGel, Axiron, and AndroDerm, tripled among men older than 40. The New England Journal of Medicine warned that only about 2% of men older than 40 should be taking the drug.
Contrary to this huge increase in prescriptions, there is little data showing that the testosterone therapy provides a benefit for all but the most severe cases of low testosterone. Low testosterone does not become a recognized medical problem until levels become extremely low, due to conditions like hypogonadism or hormonal deficiencies caused by issues such as undescended testicles, pituitary tumors, or chemotherapy.
A commentary published in August 2013 in the journal JAMA calls the “low T” campaign a template for how to sell a disease — and its cure — to a huge baby boomer market. Pharmaceutical companies have created a huge market for testosterone therapy by advertising directly to consumers and suggesting that men should be treated if they have symptoms like decreased libido, lack of energy, sadness, or falling asleep after dinner—all of which are normal, periodic feelings or symptoms.
Although the FDA has not at this time concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death, it advises health care professionals to consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. It also advises that the prescribing information in the drug labels of FDA-approved testosterone products should be followed. The FDA urges health care professionals and patients to report side effects involving prescription testosterone produces to the FDA MedWatch program.
If you or someone you know has suffered harm due to taking “low T” or other prescriptions drugs, contact Marion Munley and the Pennsylvania personal injury lawyers at Munley Law Personal Injury Attorneys at 855-866-5529.
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