TESTOSTERONE THERAPY LINKED TO FATAL CARDIOVASCULAR EVENTS
Testosterone replacement therapy may be considered in men who suffer symptoms from low testosterone, or hypogonadism. Low sex drive, erectile dysfunction, fatigue, facial hair loss, decreased muscle mass, and depression may be signs of low testosterone. Testosterone levels decline as men age, but some health conditions may contribute.
However, men generally seek testosterone therapy only when their low testosterone levels inhibit their quality of life. These therapies have serious, sometimes fatal side effects that should not be taken lightly. There are various forms of testosterone replacement therapy.
- Skin patch — Androderm
- Gels — AndroGel, Axiron, Fortesta, Testim, Natesto
- Mouth patch — Striant
- Injections — Depo-Testosterone
- Implants — Testopel
Oral testosterone pills exist, however, they are believed to cause damage to the liver.
FDA ISSUES WARNING ON APPROVED USES FOR TESTOSTERONE THERAPY
In 2015, the United States Food and Drug Administration (FDA) cautioned that testosterone products are only approved for men who have low levels caused by certain medical conditions. The agency remarks that the safety and benefit of testosterone medications have not been established for men with low testosterone due to aging.
From this warning, the FDA is requiring all manufacturers of testosterone drugs to include a label clarifying the approved usage of their medication.
FDA REQUIRES TESTOSTERONE LABEL WARNING OF HEART ATTACK, STROKE RISK
An additional warning was mandated for all testosterone products by the FDA regarding the increased risk of heart attacks and strokes in patients taking testosterone. Based on available evidence from numerous studies, the agency concluded that there is a possible link between cardiovascular risks and testosterone use. In addition, the FDA urges healthcare providers to warn patients of the potentially deadly risks before starting treatment.
Drug manufacturers of approved testosterone products are required to conduct a clinical trial on whether there is an increased risk of heart attack or stroke with their products.
Signs and symptoms of a severe cardiovascular event or stroke include:
- Chest pain
- Shortness of breath
- Trouble breathing
- Weakness in one part of the body
- Slurred speech
CONTACT AN EXPERIENCED DANGEROUS DRUG LAWYER
If you or a loved one have been injured due to testosterone therapy, you may be entitled to compensation. Since these medications and therapies have not been around for long, the long-term side effects and risk of testosterone therapy have not been determined. Pharmaceutical companies are responsible for putting safe medications on the market. When patients get injured for taking drugs to help improve their quality of life, they need to be brought to justice. Thomas J. Henry has the legal resources necessary to take down the pharmaceutical giants. Our experienced dangerous drug injury attorneys are available 24/7, nights and weekends to hear your claim. Contact us for a free legal consultation.