FDA Releases Testosterone Drug Review Two Weeks Before Panel Meeting
Federal regulators say testosterone medications may not benefit men as much as their manufacturers claim, in a review posted just shy of a public meeting to assess possible risks of AndroGel and other drugs, according to FoxNews.com.
The U.S. Food and Drug Administration (FDA) posted a review on September 3rd that discussed the costs and benefits of certain hormone-raising treatments, in which they referred to the need for testosterone replacement therapy as “debatable.” Although testosterone levels do decline with age, the FDA takes issue with particular claims that low hormone levels lead to decreased libido, fatigue, loss of muscle and other common signs of aging. Manufacturers of AndroGel, Testim, AndroDerm and other products refer to this condition as “Low T,” which can be treated with prescription therapies. Oftentimes, Fox News reports that these products are promoted for use in men who may not have abnormally low levels of the hormone, otherwise known as hypogonadism.
“There is no reliable data on the benefit in such a population,” the FDA said.
FDA to Discuss Testosterone Drug Risks at September Meeting
The FDA review was published just two weeks before its September 17th meeting to discuss testosterone medications. The meeting will involve an outside panel of advisors, and was scheduled after federally-funded research revealed an increased risk of heart attacks, strokes and other serious cardiovascular events in men who took testosterone drugs. The first study was published in November 2013 by the U.S. Veterans Affairs, and found 30 percent of older men taking testosterone to be more likely to suffer strokes, heart attacks and death, while the second suggested a doubled risk for heart attacks in men aged 65 and older taking prescription therapies.
On January 31, 2014, the FDA issued a federal testosterone drug warning that vowed to further investigate this link, which has not been confirmed.
The Fox News report fails to note the rising number of testosterone lawsuits filed in the U.S. According to court records, more than 177 claims have now been filed in a federal litigation now underway in the U.S. District Court, Northern District of Illinois. These claims blame “Low T” drug manufacturers for injuries allegedly sustained as a result of AndroGel, Testim and other products.
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