Legal Claims for Prescription Testosterone Users
Prescription testosterone therapy products approved by the United States Food and Drug Administration (FDA) are suspected of causing stroke, heart attack, and even death in men. In response to concerns raised by the publication of two scientific studies, the FDA announced on January 31, 2014, that it is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products, such as those marketed under the names AndroGel®, Androderm®, Axiron®, Bio-T-Gel™, Fortesta®, Striant®, Testim®, and Testopel®. Goldberg & Osborne attorneys with experience representing injured patients against large multinational pharmaceutical companies are investigating potential claims on behalf of people who may have been injured by prescription testosterone therapy products.
Call Goldberg & Osborne at 1-800-THE-EAGLE (1-800-843-3245)
for a free case evaluation to determine if you have a testosterone lawsuit claim.
Increased Risk of Stroke, Heart Attack, and Death; No New Warnings
Alarmingly, the FDA noted that a study of 8,709 men in the United States Veterans Affairs health system, published November 6, 2013, in The Journal of the American Medical Association “suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.” The safety of prescription testosterone therapy drugs was further questioned after the January 29, 2014, publication by PLOS ONE of a scientific study of 55,593 testosterone therapy patients. According to the FDA:
“The study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription.”
These studies prompted the FDA, which has sometimes been criticized by consumer watchdog groups for its slowness to act, to announce its new investigation into the products. The FDA did not announce that it is requiring any new warnings on labels for prescription testosterone therapy products or in pharmaceutical companies’ advertising materials. Indeed, a recent New York Times article noted that the testosterone products’ labels and advertising materials currently carry no such warning. To address this, the consumer group Public Citizen has called on the FDA to add a black box warning, the most serious kind of warning, “about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.”
Testosterone Appears to be Widely Prescribed for Unapproved Uses
According to the FDA, “testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition” such as hypogonadism. Physicians and other prescribers may, however, legally prescribe testosterone therapy products for conditions other than those approved by the FDA. This common practice is often referred to as “off label” use. This essentially means the FDA has not determined that the prescribed drug is safe and effective for the off label use.
In recent years, sales of prescription testosterone therapy drugs have increased dramatically. Some have speculated that this sharp increase in prescriptions is evidence of increasing off label use. The New York Times reported:
“Sales of prescription testosterone gels that are absorbed through the skin generated over $2 billion in American sales last year, a number that is expected to more than double by 2017. Abbott Laboratories — which owned AbbVie until Jan. 1  — spent $80 million advertising its version, AndroGel, last year.”
Aggressive direct to consumer marketing, such as that by the manufacturer of AndroGel®, emphasizes “symptoms” that many otherwise healthy men experience naturally as they age, such as “a decrease in libido (sex drive),” “a decrease in strength and/or endurance,” and even “falling asleep after dinner.” Such marketing, coupled with the absence of relevant warnings, may encourage otherwise healthy men to seek off label prescriptions without understanding the risks they face.
Experienced Goldberg & Osborne Attorneys Can Investigate a Claim
If you or a loved one has suffered a stroke, heart attack, blood clot, or death during or after using prescription testosterone therapy products, you may be entitled to compensation from the manufacturer. Call Goldberg & Osborne toll-free at 1-800-THE-EAGLE (1-800-843-3245) for a free consultation, or submit a short online case inquiry here so that Goldberg & Osborne can contact you. All states have time limits in which claims must be filed, or they will be forever barred; therefore, it is crucial that you contact Goldberg & Osborne immediately.
Goldberg & Osborne has been helping people injured by the negligence of others, including multinational pharmaceutical companies, since 1989. Goldberg & Osborne attorneys practice law only in Arizona but associate with attorneys throughout the United States.
U.S. Food and Drug Administration. Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-Approved Testosterone Products. Jan. 31, 2014 (Source).
William D. Finkle et al., Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men, PLOS One, Jan. 29, 2014 (Source).
Rebecca Vigen et al., Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels , Journal of the American Medical Association, Nov. 6, 2013 (Source).
Elisabeth Rosenthal, A Push to Sell Testosterone Gels Troubles Doctors, The New York Times, Oct. 15, 2013 (Source).
Anahad O’Connor, New Concern About Testosterone and Heart Risks, The New York Times, January 29, 2014 (Source).
Public Citizen, Public Citizen Petitions FDA for a Black Box Warning on Testosterone Products, Feb. 25, 2014 (Source).