FDA Requests Expanded Testosterone Warning Labels

testosterone warning labelsThe United States Food & Drug Administation (FDA) is requesting that manufacturers amend their low testosterone (or “Low T”) warning labels. Polycythemia is is a condition relating to an abnormal increase in red blood cells that occurs in some people undergoing testosterone treatment. It increases the risk of blood clots in the patient. Post-market reports indicate that blood clots as a result of polycythemia can be attributed to Low T therapy. Testosterone warning labels already carry a warning about blood clots related to general use. The connection to polycythemia is a relatively new revelation that is not presently reflected in the current labeling.

Hazards Associated With Low T Treatments
Testosterone treatments have increased dramatically since 2000. Low T treatments are designed to help with medical conditions that result in lower testosterone (ex. hypogonadism). Manufacturers have recently been facing lawsuits for, among other things, advertising Low T treatment as a “fountain of youth” when, in reality, many symptoms of Low T listed in the ads are just the natural side-effects of aging, many of which can be helped without the need for medication. Unfortunately, many men accepted the ads’ line of thinking and unnecessarily exposed themselves to the associated hazards when all that might have been needed was a change in diet, sleep, and exercise habits.

Lawsuits also allege that there is an increased risk of heart attack or stroke in men with preexisting cardiovascular problems, more so than is accurately represented by the manufacturers’ testosterone warning labels. This brought increased scrutiny and further review from the FDA. Women and children that were in contact with the point of application may also experience adverse side effects. Children may experience virilization, increased genital size, aggressive behavior, increased self-stimulation, and growth of pubic hair. Women may experience facial hair growth, hair loss, deepening of voice, and other hormonal problems. Testosterone can produce abnormal fetal development in pregnant women.

The Need for More Testosterone Warning Labels
Testosterone products as a whole are currently under investigation by the FDA to ensure their hazards are appropriately reflected on all testosterone warning labels. Testosterone warning labels may be subject to greater revision if the FDA confirms an increased risk of stroke, heart attack, and death in relation to the treatment. The requested change involving blood clots from polycythemia is not related to the FDA’s overall investigation. Polycythemia appears to be a potential side effect in several products, including but not limited to Natesto, AndroGel, and Aveed.

Consultation For Damages Related To Low T Treatments
A person that has experienced severe side effects while taking Low T treatments may have grounds to seek damages from the manufacturer. Stroke, heart attack, blood clots, and other cardiovascular problems have been found to be a problem in patients with previous cardiovascular health problems. If you believe a death or severe harm is related to a low testosterone treatment, contact Attorney Group today for a free consultation. A no-obligation consultation can help shed some light on the overall situation and determine if there are grounds to move forward with a lawsuit. Attorney Group can also connect you with an affiliated attorney experienced with the legal action surrounding testosterone therapy side effects. Call today to speak with an attorney or to receive more information about testosterone warning labels.