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Testosterone-boosting drugs are harmful if overused - the FDA warns

The Food and Drug Administration in U. S. has warned medical practitioners against over-prescribing these drugs, because they have been linked to a larger number of heart attacks, strokes and other severe problems in the male population.

Jeffrey Rowland, Apex Tribune, Mar 5, 2015

Testosterone drugs are increasingly popular, promising to treat symptoms like low sexual drive, mild depressive symptoms or decreased energy in aging men. Several companies, among which the most famous are AbbVie and Eli Lilly & Co., advertise these products as the solution to a wide variety of problems that are too common in older men to be explained by a single factor. However, the publicity campaigns have slogans like "You are a man. You want the facts. You get down to business. You might have low testosterone." (AbbVie's Androgel) This causes many patients to demand testosterone uppers and many doctors to release prescriptions for them. Now, the Food and Drug Administration in U. S. has warned medical practitioners against over-prescribing these drugs, because they have been linked to a larger number of heart attacks, strokes and other severe problems in the male population.

The FDA began reviewing the risks of using testosterone drugs in January 2014, because two federal studies had indicated a strong connection with heart attacks and strokes. Given that men's testosterone levels naturally decline after the age of 40, experts do not fully agree on whether this is the direct cause of other processes related to aging, like decreased energy and lower bone density.

Supplementing natural testosterone began in the 1950s with testosterone injections for men who had been diagnosed with hypogonadism (a severe clinical form of decreased testosterone levels, provoked by testicle anomalies, brain or pituitary gland malfunctions). Meanwhile, besides injections sold by Endo Pharmaceuticals, roll-ons like Lilly's Axiron or gels like Androgel (the market leading product in the field) have become available. Only that the labelling on this drugs is so imprecise that the companies selling them have advertised them to millions of men who do not have a chronic disease, but simply lower levels of testosterone than the majority. Testosterone drugs are marketed as a sort of magical solution, which has led to immense profits for the drug companies. Androgel and Axiron have been promoted so much that sales of testosterone increasing products have surpassed $2 billion. About 2.3 million U. S. male patients have been prescribed testosterone in 2013, which is 77% more than the 2010 figure.

The consumer advocacy group Public Citizen has advanced a petition to the FDA in February 2014 requesting the mentioning of heart risks on testosterone drugs in a boxed warning, but the FDA rejected the petition in July, on the account of having "insufficient evidence".

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