For men over 65 and those with heart disease, Testim (testosterone gel) could potentially double or even triple the risk of heart attack, according to a recent study. Other studies have indicated that testosterone may increase the risk of blood clots, heart attack, stroke, and death by as much as 30% during the first 3 months of treatment.
“That’s equivalent to smoking one to two packs of cigarettes a day, or having sky-high cholesterol,” according to a Mayo Clinic cardiologist who reviewed the study.
UPDATE: Testim Lawsuit Filed by Maryland Heart Attack Victim
February 5, 2015 — A man who had a heart attack and stroke after taking Testim for less than one year has filed a lawsuit against the manufacturer, Auxilium Pharmaceuticals, for failing to warn about the risk. Click here to read more.
April 14, 2014 — Auxilium is facing a wrongful death lawsuit on behalf of a 61 year-old Louisiana man who died of a heart attack after using Testim for one year. Click here to read more.
March 5, 2014 — The manufacturers of Testim (1% testosterone gel), Auxilium Pharmaceuticals, have been hit with a lawsuit from a man who suffered a stroke after using the testosterone replacement product. The lawsuit (.PDF) was filed in the U.S. District Court for the Central District of California on February 26. Click here to read more.
What is Testim?
Testim is a testosterone gel product that users apply directly on their skin. It is marketed by Auxillium Pharmaceuticals for the treatment of low testosterone, or “Low T.” Testim is approved by the FDA for hypogonadism, which can cause symptoms like fatigue, depressed mood, sexual dysfunction, and more.
What is the problem?
Testosterone levels are supposed to decline in aging men, and this is not necessarily a medical problem. Recent studies indicate that men on testosterone replacement therapy may have a higher risk of heart attack, stroke, and death. These life-threatening side effects may outweigh any benefit of treating “Low T,” especially for men who do not have hypogonadism.
Another problem is that there are no long-term safety studies of Testim. This is concerning because Testim is a lifetime commitment — it shuts down the body’s natural production of testosterone.
The Chief Cardiologist at the Cleveland Clinic, Dr. Steve Nissen, warns:
“What’s going on is a giant experiment with American men’s health at stake, because we don’t have the long-term data on the safety of these products.”
FDA Drug Safety Communication
In January 2014, PLoS One published a study of 55,000 men and found that testosterone therapy doubled the risk of heart attack for men over 65, and tripled the risk for younger men with heart disease. Within days, the FDA published a Drug Safety Communication and launched an investigation.
Testim Risks & Complications
- Blood clots
- Heart attack
- Pulmonary embolism
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Abnormal heart rhythm
- Organ damage
- And other serious side effects