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FDA Slams Low-T Drug Companies over Marketing, Issues New Health Warnings

FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change about heart attack risks.

Washington D.C. – WEBWIRE

In a brutal blow to the drug companies manufacturing and promoting so-called “Low-T” drugs like Androgel and Androderm, the FDA released new warnings to doctors against the over-prescribing of prescription testosterone drugs, saying the popular treatments were never established as safe, or approved, for treating age-related symptoms like low libido or declining energy levels.

The FDA issued a rare Safety Communication requiring the testosterone drug manufacturers to change their labels in two respects. First, to reflect the potential of an increased risk of cardiovascular risks in male users over the age of 55, which the FDA had already warned about previously in a June 2014 general warning about the higher risks of blood clots in the form of deep vein thrombosis (DVT) and pulmonary embolisms. The new updated warning further require the drug companies to expand on these warnings, and to include notification of an increased risk of heart attacks and strokes in men taking synthetic testosterone products.

The second new warning may be even more damaging to Big Pharma. It requires that health care professionals clarify the approved use of these drugs, as replacement therapy only for men who have confirmed low testosterone levels due to actual medical disorders of the testicles, pituitary gland, or brain that cause actual hypogonadism, and not simply aging-related issues.  This is a huge shift for many of these drugs, which have been promoted with a marketing blitz pitching them for everything from general fatigue, to reduced libido, and other general complaints of nearly any patient who is getting older.

For an $18 billion-dollar industry that was basically created around the marketing concept of “Low T”, and the pitching of newly created testosterone drugs as the magic bullet answer to getting older, this FDA action could end the party earlier than Big Pharma expected. Actual lab tests and diagnoses of true hypogonadism, the actual medical issue testosterone therapy was originally approved by the FDA for, are estimated to make up less than 25% of the prescriptions for low-T drugs in the past 5 years. Instead, patients were marketed to directly, and asked to “consult their doctor”, if they experienced almost any type of general complaint that would typically be associated with getting older. Health care professionals complied, and prescriptions for testosterone therapy skyrocketed, even as the actual lab tests decreased. Big Pharma cashed in, as more and more patients requested testosterone therapy, and their medical providers complied with those requests.

With thousands of men alleging they suffered the exact cardiovascular side effects warned about in the previous FDA warning currently engaged in a federal class action suit in Illinois federal court, this announcement could not have come at a worse time for companies like Abbvie (makers of Androgel) and Actavis (makers of Androderm). Plaintiffs represented by testosterone drug lawyers now number in the thousands, and more negative press about these low testosterone drugs will probably only increase the number of victims bringing suit against the drug manufacturers.


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