03/06/2015
Remember, supplements purchased in stores or online are not regulated by the FDA. You never know if the product has in it what it claims to have in it. Maybe less, maybe more, maybe none.
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FDA to require warning on labels of testosterone products.
USA Today (3/4, Szabo) reports on Tuesday the US Food and Drug Administration announced it will require manufacturers of prescription testosterone therapy “to include a warning about health risks on product labels,” and the agency advised men using such products to “contact a doctor if they develop symptoms of heart attack or stroke.”
The New York Times (3/4, A16, Tavernise, Subscription Publication) reports that two studies suggesting an association between testosterone use and heart problems prompted the FDA to reassess the safety of the products last year, and a panel of independent experts “voted overwhelmingly in September that the labels should be changed to reflect the heart risks.” In a statement, the FDA said “We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications.” According to an agency spokeswoman, companies were expected to respond by Tuesday.
According to the AP (3/4, Perrone), the FDA will also require manufacturers to “conduct a long-term study to further examine the issue.”
The Wall Street Journal (3/4, Burton, Subscription Publication) reports that a study published in JAMA in November 2013 found a 30-percent increased risk of death, heart attack, or stroke in men using testosterone, while an NIH-funded study of 56,000 men published in the journal PLOS One found that men over 65, or men under 65 with a history of heart disease, were more likely to experience a heart attack if they used testosterone products.
The Los Angeles Times (3/4, Healy) “Science Now” blog reports that the new FDA warning will require labels “to clarify that the prescription hormone is meant for use by men whose low testosterone levels are caused by certain medical conditions,” such as “genetic disorders and conditions affecting the testicles, pituitary gland and brain.”