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Labels to be changed on approved prescription testosterone products


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Stringent safety measures are being taken in regard to prescription testosterone products that the U.S. Food and Drug Administration approved. The FDA announced March 3 that it had required the makers of approved prescription testosterone products to make two key labeling changes. The first labeling change would clarify the approved uses of the products and the second would alert users to the possible increased risk of heart attack and stroke.

In regard to the heart attack and stroke risk, the FDA wrote, “Based on the available evidence from studies and expert input from an [FDA] Advisory Committee Meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone.”

As for the use of the drug, the FDA called for labeling that would reiterate its position in regard to which patients are supposed to be treated.

“Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism,” the FDA wrote. “However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

In other words, health care professionals should be apprised that testosterone replacement therapy is not for low-t, per se, but for low-t caused by serious conditions. Moreover, they should make certain that patients know the risks.

The FDA thus reminded the medical community, “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.”

The FDA originally warned about a potential health risk a year ago. This latest action basically codifies the findings on the labels and puts the industry and health care community on notice.

Today, so many testosterone replacement lawsuits either have been filed or have been anticipated that a panel of judges in Washington centralized more than a thousand such federal lawsuits before one judge for pretrial management at the U.S. District Court for the Northern District of Illinois.

The panel, which is known as the U.S. Judicial Panel on Multidistrict Litigation, concluded in June 2014 that “these actions involve common questions of fact, and that centralization of all actions in the Northern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.”

Describing the nature of the litigation, the panel wrote, “All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism. All testosterone replacement therapy actions will share factual questions regarding general causation and the background science regarding the role of testosterone in the aging body (possibly including examination of the recent studies that prompted the FDA investigation), as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.”

Men who have been diagnosed with heart attack, stroke, deep vein thrombosis, or pulmonary embolism after undergoing testosterone replacement therapy may be entitled to compensation. One sure way to find out whether there is a viable case is to contact one of the skilled product liability attorneys at Reich & Binstock for a free consultation.

In the initial consultation, a Reich & Binstock attorney, who is experienced in product liability litigation, will analyze the patient’s circumstances and will determine the legal options. It does not matter where the patient lives because Reich & Binstock operates in all 50 states.

Getting a free initial consultation is simple. Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its website.

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