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Testosterone Multidistrict Litigation Bellwether Trials

About 6,000 cases pending in the testosterone multidistrict litigation allege use of testosterone products led to blood clots, heart attack, stroke and sudden death. So far, two trials over AbbVie Inc.’s AndroGel have ended in jury verdicts against the company totaling $290 million.

*Please seek the advice of a medical professional before discontinuing the use of this lawsuit.

If you took a prescription testosterone product and suffered one of the following side effects, you may be entitled to compensation.

  • Heart Attack
  • Stroke
  • Deep vein thrombosis
  • Pulmonary embolism
  • Sudden death
Suffering from complications related to Testosterone Therapy?

Number of Lawsuits 7,411

Plaintiff Injuries Mini-stroke, stroke, heart attack and blood clotting

Defendants AbbVie Inc.; Abbott Laboratories Inc.; Pharmacia & Upjohn Inc.; Pfizer Inc.; Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals Inc.; Eli Lilly & Co. and Actavis Inc.

Bellwether Trial Dates June 5, 2017; July 17, 2017; Aug. 28, 2017; Oct. 9, 2017; Nov. 20, 2017; and Jan. 8, 2018

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Written by , on January 30, 2014

Edited on November 17, 2017

Testosterone lawsuits claim men who used testosterone replacement therapy suffered from heart attack, stroke, blood clots and sudden death.

The lawsuits, which involve the makers of popular products such as AndroGel and Depo-Testosterone, have been consolidated into a multidistrict litigation, a legal process courts use to manage many similar cases.

Lawsuit Facts About Testosterone Products

To date, 7,445 lawsuits have been filed against AbbVie, Eli Lilly & Co., Pfizer Inc. and other testosterone-product manufacturers. Two cases have gone to trial. Juries ordered AbbVie to pay $150 million and $140 million to two men who used AndroGel and suffered heart attacks.

The jury verdicts could affect settlement negotiations going forward for the more than 6,000 remaining cases, though no major settlement has been announced.

Attorneys continue to accept new cases on behalf of men who used testosterone products and then experienced heart attack, stroke or blood clots called pulmonary embolism and deep vein thrombosis.

Surviving spouses or relatives may also be eligible for compensation if their loved ones’ use of testosterone products led to sudden death.

Status of Testosterone Lawsuits

Testosterone litigation is ongoing, meaning men who believe they suffered heart attack, stroke, pulmonary embolism or deep vein thrombosis as a result of using testosterone products, such as AndroGel, can still sue the products’ manufacturers.

The litigation is in the bellwether trial phase. This means a few representative cases are going to trial first. The outcome of these cases could decide the fate of 6,000-plus lawsuits still pending.

These trials are scheduled to continue into 2018.

10 Things You Need to Know About Testosterone Lawsuits

  1. In March 2014, attorneys filed a motion to consolidate all federal testosterone lawsuits, including AndroGel lawsuits, in federal court in Illinois
  2. In June 2014, the U.S. Judicial Panel on Multidistrict Litigation ordered that 45 actions pending in four districts be consolidated and moved to the Northern District of Illinois
  3. U.S. District Judge Matthew F. Kennelly is overseeing the MDL
  4. At its peak, MDL-2545 IN RE: Testosterone Replacement Therapy Products Liability Litigation included 7,445 lawsuits
  5. In February 2017, the testosterone MDL had the sixth most pending lawsuits out of the 236 MDLs that had been established in U.S. federal courts
  6. The MDL is in the bellwether trial phase, which means the court has selected a few cases to go to trial so both sides can test their arguments with the goal of resolving the remaining cases
  7. Two AndroGel cases have gone to trial so far: one case initially resulted in a mistrial; in the end, the cases ended in $140 million and $150 million jury verdicts against AbbVie Inc.
  8. Four additional AndroGel trials are scheduled, with the last set to start in January 2018
  9. There have been no major publicized settlements as of yet; however, the two jury verdicts total $290 million
  10. Men and their families can still sue testosterone manufacturers for injuries including heart attack, stroke, deep vein thrombosis, pulmonary embolism and sudden death

Testosterone Multidistrict Litigation

The U.S. Judicial Panel on Multidistrict Litigation created the testosterone multidistrict litigation, or MDL, in June 2014 as a way of streamlining the pretrial proceedings for many similar lawsuits against makers of testosterone products.

The panel ordered that 45 lawsuits pending in four districts be consolidated and moved to the Northern District of Illinois. U.S. District Judge Matthew F. Kennelly is overseeing the MDL, formally called MDL-2545 IN RE: Testosterone Replacement Therapy Products Liability Litigation.

In issuing its order, the panel stated:

“All actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include heart attack, stroke, deep vein thrombosis, and pulmonary embolism.”

The number of lawsuits in the MDL reached 7,445, according to the U.S. District Court Northern District of Illinois website. As of October 2017, 6,068 remained pending.

Of the 236 MDLs across the U.S., the testosterone MDL is especially complicated, with the sixth most pending actions, according to the U.S. Judicial Panel on Multidistrict Litigation’s February 2017 MDL statistics report.

Testosterone MDL Timeline

  • January 2014

    The FDA announced it was “investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.”

  • February 2014

    Five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel.

  • March 2014

    The multidistrict litigation panel received a motion to consolidate all federal testosterone lawsuits, including the AndroGel lawsuits, in federal court in Illinois.

  • June 2014

    The panel ordered 45 actions pending in four districts be consolidated and moved to the Northern District of Illinois.

  • August 2014

    The court appointed attorneys to serve in leadership roles in the multidistrict litigation.

  • September 2015

    The court designated attorneys who will serve in leadership roles throughout the rest of the litigation.

  • August 2016

    U.S. Judge Matthew F. Kennelly selected AbbVie cases for bellwether trials.

  • March 2017

    The court appointed a settlement master to meet with both sides on a monthly basis to discuss settlement.

  • June 2017

    The first AbbVie bellwether trial ended in a mistrial after an attorney was hospitalized for a heart problem.

  • July 2017

    The second AbbVie bellwether trial ended in a $150 million jury verdict against AbbVie.

  • September 2017

    A jury decided ordered AbbVie to pay $140 million to a man who used AndroGel and suffered a heart attack.

  • January 2018

    The sixth and final scheduled AndroGel bellwether trial is expected to start.

Injuries You Can Sue For: Heart Attack, Stroke, Blood Clots & Death

Men who used testosterone products as prescribed by a doctor and suffered heart attack, stroke, pulmonary embolism or deep vein thrombosis may be eligible for compensation through a lawsuit. Relatives of men who died suddenly after using these products may also be eligible.

INJURIES YOU CAN SUE FOR INCLUDE:

Heart attack

Testosterone products are linked to an increased risk of heart attack

Stroke

Men who used testosterone gels were 30 percent more likely to suffer from a stroke, also called a cerebrovascular accident or CVA

Pulmonary embolism

Blood clots caused by testosterone therapy can block arteries in the lungs

Sudden death

Lawsuits say there is casual relationship between use of testosterone products and sudden cardiac death

Deep vein thrombosis

Dangerous blood clots that can travel to deep veins in the legs can develop as quickly as one month after starting testosterone treatment

Testosterone Lawsuit Allegations

Thousands of testosterone lawsuits filed in federal court all make the same allegation: Manufacturers of testosterone products put healthy men in danger by marketing the hormone to treat sexual dysfunction, age-related fatigue and other symptoms that go beyond the use approved by the U.S. Food & Drug Administration.

Testosterone replacement therapies were approved for use in the treatment of a medical condition known as hypogonadism, but drugmakers widely marketed the products for off-label use for a condition they allegedly invented and call “Low T.”

Lawsuits accuse makers of testosterone products of marketing the products as safe and effective for this off-label use, when in fact, the products reportedly provide little or no benefit for men without hypogonadism and the drugs can cause heart attack, stroke, blood clots and sudden death — serious medical problems for which the companies allegedly failed to provide adequate warnings.

Lawsuits accuse testosterone companies of:

  • Misrepresenting testosterone products as a safe and effective treatment for hypogonadism — the drastic decline in hormone levels caused by injury or disease — despite causing serious side effects
  • Exaggerating the benefits of their products and understating, omitting and/or failing to adequately warn patients and physicians about the risks and the monitoring required to ensure patient safety
  • Using “aggressive, award-winning direct-to-consumer and physician” marketing tactics to convince men to discuss testosterone therapy with their doctors
  • Engaging in “disease mongering” to increase sales instead of adequately warning consumers about the risks

Brands Named in Lawsuits: AndroGel, Depo-Testosterone & Fortesta

AndroGel is the testosterone product most often named in lawsuits. AbbVie Inc. manufactures AndroGel. AbbVie’s parent company, Abbott Laboratories, bought AndroGel from Solvay in 2010 and is also named in lawsuits.

Other brands named in lawsuits include Pfizer’s Depo-Testosterone, Eli Lilly & Co.’s Axiron, Endo Pharmaceutical’s Foresta and Auxilium Pharmaceuticals Inc.’s Testim. Actavis Inc. also faces lawsuits over its testosterone gel, Androderm.

Men who suffered heart suffered heart attack, stroke, pulmonary embolism or deep vein thrombosis may be eligible for compensation if they used any of the following testosterone products:

Brand Manufacturer
AndroGel AbbVie Inc.; Abbott Laboratories Inc.; AbbVie Products; Unimed; Solvay; Besins Inc.; Besins S.A.
Depo-Testosterone Pfizer Inc.; Pharmacia & Upjohn Inc.
Foresta Endo Pharmaceuticals
Delatestryl Endo Pharmaceuticals
Testim Auxilium Pharmaceuticals Inc.; GlaxoSmithKline; Endo Pharmaceuticals
Testopel Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals
Striant Auxilium Pharmaceuticals Inc.; Endo Pharmaceuticals
Androderm Actavis Inc., Actavis Pharma Inc., ALU, and Anda, Inc.

AndroGel Lawsuit

AndroGel is the most widely used type of testosterone replacement therapy. The drug brought in $1.15 billion in sales in 2012 alone. Sales in 2016 were $675 million.

AndroGel lawsuits say manufacturers Abbott and AbbVie “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs “while downplaying known adverse and serious health risks,” Bloomberg reported.

One of the men who sued AbbVie was then-54-year-old Michael Gallagher of Virginia. He suffered myocardial infarction, congestive heart failure and other injuries after being prescribed the gel. He had no history of cardiac problems before taking the prescription drug. Gallagher claims he started AndroGel therapy after the defendants’ advertisements led him to attribute symptoms to low testosterone.

Depo-Testosterone Lawsuit

Several manufacturers of testosterone drugs are facing lawsuits in court filed by men who suffered heart attacks, blood clots and strokes. Pfizer and Pharmacia & Upjohn Co. are no exception.

In September 2014, Alvaro Roman Gutierrez took his case to court after using Depo-Testosterone and suffering heart problems he blames on the drug. He accuses Pfizer of “disease mongering” by downplaying the risks of the drug and exaggerating its benefits.

“As a direct and proximate result of the plaintiff’s use of Depo-Testosterone, also known as Testosterone Cypionate, and plaintiff’s reliance on defendants’ representations regarding the character and quality of the products and defendants’ failure to comply with federal requirements, plaintiff suffered serious physical injury, harm, damages and economic loss and will continue to suffer such harm, damages and economic loss in the future,” Gutierrez says in his complaint.

The complaint also says the drugmaker had a duty to warn the public and did not. Pfizer denies any wrongdoing and stands by its drug.

“We do not believe that the cases against Pfizer have merit, and we intend to defend these cases vigorously in court”

- Pfizer spokesman Steven Danehy said in a statement

Pfizer is accustomed to fighting hormone drug lawsuits. In 2012, it paid $896 million to women who said their breast cancer was caused by the drug. Some doctors warn that testosterone might follow the same path as estrogen therapy.

Bellwether Trials and Testosterone Verdicts

AbbVie Inc. was the first testosterone manufacturer on trial. Judge Kennelly, the Illinois federal judge overseeing the MDL, identified about a half-dozen AbbVie cases for bellwether trials, which are test cases intended to try a widely contested issue.

The first four cases in the bellwether trials involve plaintiff claims that AndroGel caused myocardial infraction (heart attack) or stroke. The second group is made up of cases that allege blood clot injury, including pulmonary embolism and deep vein thrombosis.

Two cases over AbbVie Inc.’s AndroGel have been decided:

  • In June 2017, jurors began to hear the case of Jeffrey Konrad, a Tennessee man who says he suffered a heart attack after using AndroGel. However, the trial ended in a mistrial after an attorney was hospitalized for a heart problem. Konrad did eventually get a full trial in September. A jury awarded him $140 million.
  • In July 2017 a second bellwether case went to trial. Attorneys for Jesse Mitchell told the jury that the Oregon man suffered a heart attack at age 43, four years after he started using AndroGel. Jurors deliberated for about four days. They concluded AbbVie’s negligence was not the cause of Mitchell’s heart attack. Still, the jury found the company liable for false marketing, or fraudulent misrepresentation, and ordered AbbVie to pay Mitchell $150 million.

Androgel Bellwether Cases:

Jeffrey Konrad v. AbbVie Inc.

PLAINTIFFS: Jeffrey and Jana Konrad
ALLEGED INJURY: Heart attack
DATE OF ALLEGED INJURY: July 9, 2010
DATES OF ALLEGED ANDROGEL USE: May 2010 – June 2010
AGE AT INJURY: 49
AGE AT FIRST PRESCRIPTION: 49
TRIAL STATUS: Jury ordered AbbVie to pay Konrad $140 million

Jesse Mitchell v. AbbVie

PLAINTIFF: Jesse Mitchell
ALLEGED INJURY: Heart attack
DATE OF ALLEGED INJURY: November 18, 2012
DATES OF ALLEGED ANDROGEL USE: December 2007 – November 2012
AGE AT INJURY: 49
AGE AT FIRST PRESCRIPTION: 44
TRIAL STATUS: First trial ended in mistrial; later a jury ordered AbbVie to pay Mitchell $150 million

Arthur Myers v. AbbVie

PLAINTIFF: Arthur Myers
ALLEGED INJURY: Pulmonary embolism
DATE OF ALLEGED INJURY:February 7, 2008
DATES OF ALLEGED ANDROGEL USE: June 2003 – August 2008
AGE AT INJURY: 42
AGE AT FIRST PRESCRIPTION: 37

Robert Nolte v. AbbVie

PLAINTIFF: Robert Nolte
ALLEGED INJURY: Pulmonary embolism
DATE OF ALLEGED INJURY: November 1, 2012
DATES OF ALLEGED ANDROGEL USE: August 2012 – December 2012
AGE AT INJURY: 72
AGE AT FIRST PRESCRIPTION: 72

Robert Rowley v. AbbVie

PLAINTIFF: Robert Rowley
ALLEGED INJURY: Deep vein thrombosis
DATE OF ALLEGED INJURY: April 27, 2013
DATES OF ALLEGED ANDROGEL USE: April 2012 – April 2013
AGE AT INJURY: 67
AGE AT FIRST PRESCRIPTION: 66

Edward Cribbs v. AbbVie

PLAINTIFF: Edward Cribbs
ALLEGED INJURY: Heart attack
DATE OF ALLEGED INJURY: May 25, 2012
DATES OF ALLEGED ANDROGEL USE: March 2010 – April 2014
AGE AT INJURY: 61
AGE AT FIRST PRESCRIPTION: 59

Cecile Frost v. AbbVie

PLAINTIFF: Cecile Frost
ALLEGED INJURY: Stroke
DATE OF ALLEGED INJURY: February 21, 2013
DATES OF ALLEGED ANDROGEL USE: January 2012 – February 2013
AGE AT INJURY: 59
AGE AT FIRST PRESCRIPTION: 58

Testosterone Lawsuit Settlements

No settlement to resolve the remaining testosterone lawsuits had been announced as of October 2017.

Judge Kennelly appointed Randi Ellis as the MDL’s settlement master in March 2017. Kennelly ordered Ellis to meet with both sides to discuss settlement.

Ellis is an attorney who is frequently called upon to facilitate settlements.

Testosterone Class Action Status

Currently, there are no testosterone class action lawsuits publicized in the U.S.

The attention surrounding testosterone lawsuits is on the federal multidistrict litigation in Illinois.

All federal testosterone lawsuits have been consolidated and transferred to the MDL as a way of conserving time and resources.

Although testosterone class actions are not in the forefront right now, an MDL can lead to a class action.

FDA Actions and Testosterone Studies

Several studies have assessed the safety of testosterone products and found increased risk of heart attack, stroke and blood clots. As a result, the FDA has launched investigations into the products and now requires manufacturers include warnings about these risks on the products’ labels.

After one FDA safety announcement in 2014, five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel. The plaintiffs’ ages range from 50 to 63. Three of the men suffered heart attacks, and two suffered strokes. Scores of lawsuits followed.

Testosterone Risk Studies

Studies published as recently as February 2017 link testosterone products to serious and even deadly side effects, including heart attack, blood clots and stroke.

Heart Attacks

A study published in February 2017 in the Journal of the American Medical Association found an association between testosterone treatment and a significant increase of coronary artery plaque, which can reduce the flow of oxygen to the heart.

An earlier study published in 2014 revealed a two-fold increase in the risk of heart attack among men who recently started testosterone therapy.

Blood Clots

Clinical and Applied Thrombosis/Hemostasis published a study in 2013 that found 1.2 percent of men who were hospitalized for deep vein thrombosis or pulmonary embolism had developed the blood clots within three months of starting testosterone therapy.

Strokes

Studies found men who used testosterone products were 30 percent more likely to suffer from strokes. According to a Los Angeles Times report, some of the study participants had to undergo “emergency artery-clearing.

Questionable Marketing

Drug companies that manufacture testosterone replacement drugs like AndroGel heavily market their products promising a better quality of life for men. It’s not uncommon for several television ads to air during football games and shows that target men. Many of these direct-to-consumer ads attributed symptoms associated with aging, such as fatigue and loss of libido, to Low T.

Advertisements for AndroGel, for example, popped up soon after the 2000 FDA approval of the product and became more and more prevalent over time. AbbVie spent $75.6 million on direct-to-consumer marketing for AndroGel in 2012 and $67.9 million in 2013, according to data from market-researcher Kantar Media.

Aggressive marketing tactics such as these have been criticized for allegedly luring otherwise healthy aging men to testosterone. Direct-to-consumer marketing campaigns promote testosterone as a way of regaining youthful levels of energy, sex drive, strength and muscle mass while downplaying potential side effects.

The FDA, however, approved testosterone only to treat specific medical conditions that lead to a drop in testosterone levels in men. But more and more men are using the drugs off-label to treat a wide range of symptoms related to the aging process, such as energy loss, decreased muscle mass and reduced libido.

The New Viagra

Drugmakers often try to increase profits by creating new, unproven uses to piggyback on existing FDA approvals, putting patients at risk by making misleading statements about the drugs’ safety and effectiveness for those unapproved purposes.

It appears makers of testosterone therapies put a new twist on this marketing scheme. Manufacturers like Eli Lilly & Co. and Abbott Laboratories are riding on the successful marketing of Viagra and other erectile dysfunction treatments to encourage men to ask their doctors about testosterone replacement.

Testosterone: ‘The Fountain of Youth’

Websites and TV ads show middle-aged men longing to rejoin sporting activities and ask men if they’ve lost their energy. Direct-to-consumer marketing quizzes set men up to believe that natural signs of aging point to a testosterone deficiency.

However, the FDA warns that “the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.” And recent clinical trials found that testosterone did not have an effect on memory or cognitive abilities in older men.

“Low-T” Marketing

Marketing efforts suggest decreased energy levels are caused by Low T rather than by aging or any number of other factors. Once this energy–Low T connection is made, consumers are persuaded to visit their doctors seeking Low T therapy to help them regain vitality.

Eli Lilly & Co., AbbVie and other testosterone product manufacturers face criticism for these and other tactics. They created a $1.6 billion market for testosterone replacement drugs, and critics say they haven’t done enough to inform consumers and doctors about potential risks. Drugmakers have a legal duty to warn consumers and doctors about any known risks associated with their drugs.

Recipe for Pharmaceutical Negligence

While the controversy continues, it’s clear that drugmakers are reaping the rewards of successful marketing of testosterone treatments. But at least one Low-T drugmaker has reportedly come under fire for its marketing practices.

According to a report by McClatchy, a whistleblower lawsuit filed in federal court in Texas alleges that Solvay Pharmaceuticals, formerly Unimed Pharmaceuticals, used improper sales practices to market AndroGel.

The FDA approved AndroGel to treat hypogonadism, but the drugmaker allegedly recruited doctors to help AndroGel “ride (the) coattails of Viagra” by encouraging them to screen patients seeking Viagra for low testosterone. A former sales manager involved in the lawsuit attributes AndroGel’s high sales to the company’s decision to promote the drug for off-label uses even though it isn’t approved to treat erectile dysfunction (ED) like Viagra is.

DETAILS ABOUT UNIMED PHARMACEUTICALS:

  • In 1999, it reportedly projected treating a market of 1 million men for hypogonadism.
  • By the time the drug was approved in 2000, it estimated its market at up to 5 million men.
  • By 2003, corporate managers had reportedly expanded that number to 20 million men. (There are an estimated 116 million adult men in the U.S.)
  • Abbott Laboratories is AndroGel’s current owner.
  • Serious health risks and aggressive marketing for off-label purposes frequently form a recipe for negligence and widespread pharmaceutical injuries.
  • Pharmaceutical companies that hurry to market a drug without proper approvals often end up accused of inadequate testing or concealing risks.
  • When they fail to protect consumers and warn about those risks, they may be held legally liable for any injuries that result from their negligence.

Author

emiller@drugwatch.com
407-955-4198

Emily Miller holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science and the Society for Technical Communication. Emily was diagnosed with a chronic illness as a child and has firsthand experience with many of the topics she writes about as a member of the Drugwatch team. She is an award-winning journalist who has reported on health and legal news for reputable organizations, including the South Florida Sun Sentinel, San Antonio Express-News, UF Health News and Reporters Committee for Freedom of the Press. She draws on her background as both a patient and a journalist to help readers understand complex health and legal topics.


Hide Sources

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