When taken by men over the age of 65, or by younger men with a history of heart disease, testosterone supplements may cause serious cardiac emergencies. Side effects of testosterone have been reported to include heart attack, stroke, pulmonary embolism, blood clots, and other adverse health complications.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the testosterone booster and our lawyers can help.
Update: Testosterone Supplements may be Addictive, FDA Warns
January 18, 2017 – The FDA has approved class-wide label changes for all prescription testosterone boosters regarding a risk of abuse and dependence associated with use of the medications. The new warnings alert prescribers that some patients may abuse testosterone supplements, and that adverse outcomes may result. FDA reminds users that prescription testosterone therapy is approved only for men “who have low testosterone due to certain medical conditions.”
Testosterone Supplements Linked to Heart Attack
According to the new study, which was published in the journal PLoS One on January 29, 2014, men over the age of 65 had rates of heart attack that rose as much as threefold in the 90 days after they filled a prescription for testosterone replacement therapy (TRT). The research marks the 3rd time in 4 years that a scientific study has found signs that testosterone boosters may carry adverse health consequences for men.
In 2010 and again in November 2013, studies published in the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA) determined that male testosterone users, particularly those who were frail, elderly or had a history of cardiovascular disease, had an increased risk of suffering a range of cardiovascular ‘events’ — ranging from heart attacks to emergency artery-clearing procedures — soon after they initiated treatment.
What is Testosterone Replacement Therapy (TRT)?
TRT is the use of hormone replacement for men who are no longer capable of producing sufficient amounts of testosterone by themselves. This is a common medical condition, and the drugs used to treat it are testosterone and other similar androgenic compounds. Levels are routinely monitored by doctors to keep patients in the middle range. Injectable and gel testosterone boosters are widely available. Oral androgen replacement is used only in rare cases, since it has been linked to liver cancer.
Popular testosterone boosters include:
Looking at a medical records database of 55,593 men who received prescriptions for testosterone replacement therapy between 2006 and 2010, the PLoS One study compared the test subjects to themselves before and after filling their 1st prescription. The researchers then compared the men who received testosterone prescriptions to a similar group of men who were issued a 1st prescription for an erectile dysfunction (ED) drug. Men in both groups tend to be similar in age, have similar health issues, and experience similar symptoms, so are ideal for comparison. But since ED meds do not affect hormones, and work differently than testosterone boosters, the researchers concluded that the heart attack rates were caused by a drug effect, not just a correlation between those using a medication and a negative outcome. By both measures, older testosterone users, and younger ones with a history of heart disease, were significantly more likely to suffer a heart attack shortly after beginning a regimen.
According to the researchers, additional studies should be performed to clarify which men may be at an increased risk of sustaining injuries from testosterone replacement therapy. Until those are conducted, doctors counseling male patients who seek testosterone “might be well advised to include serious cardiovascular events in their discussion with patients of potential risks, particularly for men with existing cardiovascular disease.”
Side Effects of Testosterone
Severe side effects of testosterone replacement therapy include:
- Heart attack
- Blood clot
- Pulmonary embolism (PE)
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
- Transient ischemic attacks
- Sudden death
Other, more moderate side effects may include:
- hair loss
- trouble sleeping
- change in sexual desire
- redness/swelling of the skin
- change in skin color
Before Taking Testosterone
If you think you may be suffering from Low T, you should get a blood test to see if treatment is warranted. Getting an accurate read on your testosterone levels can be tricky, so experts recommend getting at least 2 blood tests to account for day-to-day variations. A test in the morning before breakfast is best to get an accurate measurement, since levels are typically highest in the morning and while fasting.
FDA Requires Heart Attack, Stroke Warning to be Added to Testosterone Supplement Labels
March 3, 2015 – FDA issued a press release today announcing label changes that will be applied to all approved prescription testosterone supplements. The updated labeling warns that testosterone has been linked to heart attack, stroke, and other severe cardiovascular side effects, and that the supplements should not be prescribed to men for the sole purpose of treating symptoms associated with the normal aging process. Click here to learn more.
Despite Dangers, ‘Low T’ Treatments Gaining in Popularity
The problems associated with testosterone supplements have mounted amid explosive growth for patches, topical gels and creams, which are now used by nearly 3% of American men over the age of 40. Between 2000 and 2011, prescriptions for testosterone boosters increased 5-fold, driven by aggressive marketing campaigns which urged men with diminished energy, poor muscle tone and low libido to get treated for ‘low T.’ Each year, Americans spend more than $1.5 billion on testosterone supplements, a market that is becoming increasingly dominated by younger men.
FDA Panel Recommends Tighter Restrictions on TRT Industry
In September 2014, an expert panel voted overwhelmingly in favor of the FDA restricting labels for testosterone boosters so they are no longer prescribed to men who only have problems related to the natural aging process, such as decreased energy and libido.
“The whole idea is to try to rein in the inappropriate advertising and use of these drugs,” said Michael Domanski, director of heart failure research at Mount Sinai School of Medicine.
FDA officials had previously issued warning letters to sponsors over inappropriate and misleading testosterone advertising campaigns. The new reforms could also potentially limit coverage from insurance companies for TRT use.
Testosterone Ads Likened to ‘Disease Mongering’: Editorial
The authors of a new editorial published in Journal of the American Geriatrics Society (AGS) have called the sales pitch used by many testosterone makers “disease mongering,” and said the advertisements to be banned. “Normally the FDA does not allow advertising of products for indications that they have not approved,” the authors say. “The FDA has said aging is not an indication. Well let’s take that a step further and say you can’t advertise testosterone for something called Low T. That’s not an approved indication.”
Click here to learn more.
NJ Man Sues Eli Lilly After Axiron Heart Attack
A New Jersey man recently filed a lawsuit against Eli Lilly & Co., alleging that the company failed to adequately warn about the heart attack and stroke risk associated with its testosterone supplement Axiron, according to The New Jersey Law Journal. Plaintiff Patrick Miller of Hopatcong, NJ, started taking Axiron in September 2012, and had a heart attack a month later. According to the complaint, Miller’s doctor would not have prescribed him Axiron if he had known the potential health risks.
Testosterone Stroke Lawsuit Filed in CA
July 31, 2014: A California man who allegedly had a stroke after using Depo-Testosterone has filed a product liability lawsuit against Pfizer Inc. According to court documents, plaintiff Gonzalo Menendez took Depo-Testosterone for less than 3 months before suffering multiple acute infarctions, placing him at risk for additional cerebrovascular accidents and sudden death. Click here to learn more.
The Testosterone Trial
The National Institutes of Health (NIH) is currently in the process of conducting a clinical trial to determine whether prescription testosterone supplements can help older men perform better physically, mentally and sexually. The study, called The Testosterone Trial, will include 800 men in 12 U.S. cities, and is designed to help consumers make informed decisions about the risks vs. rewards of TRT.
EMA Weighs in on Testosterone Heart Risks
On October 10, 2014, a report by the European Medicines Agency (EMA) stated that the evidence linking testosterone supplements to cardiovascular side effects was inconsistent, and that additional research into the matter is needed. However, EMA also stressed that TRT products should only be prescribed to men who have been clinically diagnosed with hypogonadism (low testosterone), and that the European Union has not approved the drugs for use in healthy, older men.
Testosterone and Prostate Cancer
Two recent studies found that testosterone raised the risk of prostate tumors and worsened the effects of carcinogenic chemical exposure in laboratory rats. Researchers administered testosterone to the animals through slow-release implants. Before the rats were dosed, some were injected with the carcinogenic chemical N-nitroso-N-methylurea. Among the rats that received testosterone without this chemical, 10 to 18% developed prostate carcinomas. When rats were exposed to testosterone and the carcinogen, 50 to 71% developed prostate cancer. Rats that were exposed to the carcinogenic chemical but not testosterone did not develop the disease.
“This research demonstrates that testosterone on its own is a weak carcinogen in male rats,” said study author Maarten Bosland from the University of Chicago. “When it is combined with cancer-causing chemicals, testosterone creates a hospitable environment for tumors to develop. If these same findings hold true in humans, there is serious cause for public health concern.”
Type 2 Diabetics with “Low T” may have Increased Risk of Heart Disease: Study
A recent study conducted in Argentina found that men who have low testosterone levels — along with type 2 diabetes — have an increased risk of developing heart disease compared to diabetics with normal T levels. Researchers at Universitario Sanatorio Guemes Hospital identified a link between low concentrations of testosterone and atherosclerosis, a cardiovascular disease that occurs when artery walls thicken due to the accumulation of white blood cells. Click here to learn more.
First AndroGel Heart Attack, Blood Clot Lawsuits To Go To Trial Late 2016
Coordinated litigation involving injuries allegedly caused by AndroGel continues to move forward in Illinois federal court, with early trials tentatively scheduled to begin in late 2016. A case management plan created by the judge overseeing the litigation outlines a process by which bellwether trials will be selected and a potential calendar for trial dates. Click here to learn more.
Judge Denies Motion to Dismiss Nearly 40 Testosterone Lawsuits
An attempt to dismiss 39 lawsuits filed against the makers of prescription testosterone supplements was rejected by the judge overseeing the multidistrict litigation pending in the Northern District of Illinois. The testosterone manufacturers asked Judge Matthew F. Kennelly to dismiss the complaints for various reasons, including the plaintiffs’ failure to effectively demonstrate that testosterone supplements caused their injuries. According to the defendants, scientific studies used by the plaintiffs have been discredited, and the link between testosterone and cardiovascular side effects has not be “conclusively proven.” Click here to learn more.
Testosterone Lawsuit Allegations
- Manufacturers misrepresented testosterone supplements as safe and effective
- Marketing and advertising campaigns ignored potential risks of TRT treatment
- Testosterone manufacturers placed sales ahead of adequate warnings
Additional Resources & Information
- First Status Conference Scheduled in Testosterone Lawsuit Multidistrict Litigation
- Judicial Panel Denies Pfizer’s Attempt to Exclude Depo-Testosterone Lawsuits from Consolidation
- FDA Requests Blood Clot Warnings on Labels of Testosterone Supplements
- Public Citizen Calls for Black Box Warning on Testosterone Supplements
- Pfizer Argues Testosterone Lawsuits Should Be Limited to Gel Formulations
Do I Have a Testosterone Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Testosterone Lawsuits. We are handling individual litigation nationwide and currently accepting new testosterone injury and death cases in all 50 states.
Free Case Evaluation: Again, if you were injured by the side effects of a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.