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AndroGel, Testosterone Therapy Lawsuits Filed Over Heart Risk

This Alert Affects:

Men who experienced a heart attack, stroke or other complications after using prescription testosterone therapies.

What's the Problem?
It is believed that prescription testosterone may increase the risk of heart problems in older men.
Blood clots, stroke, ischemic stroke, high blood pressure, heart attack and death.
FDA Warning
In March 2015, the FDA announced that all testosterone replacement therapies must have their labels updated to warn patients about the risk of suffering heart attacks and strokes when using the prescriptions. The label update was prompted by several recent studies that suggested these therapies were linked to various heart problems.
What is AndroGel?
AndroGel is a prescription gel medication used to treat low levels of testosterone, also known as "Low T." Testosterone therapies can also come in the form of a patch or injection.
Are Any Other Products Affected?
Testosterone therapies are also sold as Axiron, Fortesta, Striant, Delatestryl, Testopel, Androderm, Bio-T-Gel, Depo-Testosterone, and Testim.
Type of Lawsuit
Mass Tort

Attorneys across the country are filing lawsuits on behalf of men who used AndroGel and other testosterone therapies in light of new information linking the “Low T” products to heart attack, stroke and death in users. A recent study found that middle-aged men with a history of heart disease and men ages 65 and older were twice as likely to have a heart attack after using prescription testosterone. These lawsuits are alleging that patients were not properly warned about the products’ risks and, as a result, may be able to collect compensation for medical bills, pain and suffering and other damages from the manufacturer. 

Have you suffered from a heart attack? Were you prescribed AndroGel or another testosterone medication? If so, you may have legal recourse. To learn more about your potential legal rights, fill out ClassAction.org’s free case review form today.

Studies Link AndroGel, Testosterone Prescriptions to Blood Clots, Heart Attacks and Strokes

Heart Attack Studies

A recent study published in the journal PLOS ONE tracked more than 50,000 men who were new prescription testosterone users and compared their rates of heart attacks before and after starting use of the products. Researchers found that middle-aged men with a history of heart disease and men ages 65 and older were twice as likely to have a heart attack after using prescription testosterone, the New York Times reported.

Stroke Study

A similar study, published in The Journal of the American Medical Association (JAMA), found that men treated with testosterone therapy were at a 30 percent increased risk of having a heart attack or ischemic stroke, also known as a mini stroke. In this study, researchers administered testosterone in three different forms: gels, injections and patches. Although they reported that the complications were not associated with any one form of administration, it appeared that men were at a higher risk for complications the longer they received testosterone therapy.

In 2009, researchers were forced to discontinue a study on testosterone gel. Originally, they wanted to test whether the gel could help older men build muscle and increase strength, but the study was never completed because some of the participants were experiencing cardiac problems, including heart attacks.

FDA Requires Label Updates on Low T Therapies to Warn of Heart Attack, Stroke Risk

In January 2014, the FDA said that it would be investigating the safety of prescription testosterone therapies following the publication of these studies. After reviewing the studies’ findings, the FDA announced in March 2015 that all makers of prescription testosterone products would be required to update their products’ labels to better warn patients and doctors about the risk of suffering heart attacks and strokes.

In its safety communication, the FDA also noted that these products are being over-prescribed to men suffering from low testosterone due to aging and should only be prescribed to men who have low testosterone levels related to a diagnosed medical condition. Therefore, the FDA said that the labels for these drugs must also be updated to clarify their only approved use.

How Does Prescription Testosterone Cause Heart Attacks?

Prescription testosterone may cause heart attacks, strokes and blood clots because of its influence on red blood cells. When testosterone is administered through a gel, patch, or injection, it can increase the amount of red blood cells in the body. As a result, these blood cells can begin to coagulate, or bunch together, causing the blood to thicken. Coagulation makes it more difficult for blood to flow throughout the body, which can cause high blood pressure and heart problems. Older men may be particularly at risk for these complications, because their arteries may be narrow due to old age or disease.

How Can Filing an AndroGel Lawsuit Help Me?

An AndroGel lawsuit may provide victims with compensation for past and future medical bills, lost wages and pain and suffering. In the event of death, a lawsuit may also provide compensation for funeral expenses.

It has been reported that AndroGel and other testosterone therapies do not carry warnings for heart attack, stroke or death on their labels. By filing a lawsuit, you may also be able to hold these manufacturers responsible for releasing a product into the marketplace without adequate warnings.

Is This a Class Action?

While some consumers are calling for a class action, AndroGel lawsuits will likely proceed on an individual basis. Class action lawsuits are typically reserved for instances in which a large number of consumers have suffered minor losses, such as the cost of replacing an appliance; however, attorneys believe that men are suited for individual lawsuits because they have incurred substantial losses, which may include costly medical bills.

Were you or a loved one injured after using AndroGel or another form of prescription testosterone? If so, ClassAction.org would like to hear from you today. To see if you may be able to file a lawsuit, fill out our free case review form.

You can read one of the complaints below:

Mar 31, 2014
Consumer Fraud

Testosterone Lawsuits: Drug Companies Committed Fraud

by Christopher Placitella

Following the publication of several medical studies showing that testosterone gel users have a significantly higher risk of suffering heart attacks or strokes… More

Feb 6, 2014
Dangerous Drugs

AndroGel Lawsuits Filed After FDA Announces Probe into Low T Products

by Simon Clark

Following the FDA's announcement that it will be reassessing the safety of prescription testosterone products, Abbot Laboratories Inc. and AbbVie Inc., the companies that manufacture… More

Feb 5, 2014
Dangerous Drugs

FDA Investigates Testosterone Products Over Heart Risks

by Simon Clark

The New York Times reported last week that a new study has revealed that prescription testosterone drugs raised the risk of heart attacks in certain patients with a history of heart problems.… More

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Case Resources

Aurecchia v. AbbVie Inc. Complaint
Case number 1:14-cv-772, U.S. District Court for the Northern District of Illinois
In re Testosterone Replacement Therapy Products Liability Litigation Transfer Order
MDL number 2545, U.S. District Court for the Northern District of Illinois
JAMA Study, November 2013
Researchers find that men who used testosterone products following coronary angiography (imaging of the blood vessels in the heart) were 30 percent more likely to suffer strokes, heart attacks and death, compared to those who did not use prescription testosterone.
PLOS One Study, January 2014
Researchers find that men taking testosterone products who are 65 and older or who have pre-existing histories of heart disease are two to three times more likely to suffer heart attacks, compared to those who do not use testosterone products.
FDA Drug Safety Announcement, January 2014
The FDA announces it is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.
FDA Drug Safety Communication, March 2015
The FDA requires label changes for all testosterone therapies to better communicate the risk of suffering heart attacks and strokes when using these products.