AndroGel, a product manufactured by AbbVie, is the most popular of the prescription products intended for use as daily testosterone replacement therapy (TRT). Since 1937, TRT has been used clinically to improve testosterone levels in men with lower than standard levels of testosterone. FDA approved the use of this therapy in 1953. The number of testosterone prescriptions received by men in the U.S. has increased threefold since 2001.  Since this type of treatment has gained massive popularity over the years, it is currently administered in at least five forms, including injections, patches, and gels.

A 2006 study shows that testosterone levels in men begin to spike at puberty and drop by about 1% each year after age 30. While a reduction of testosterone levels in older men tend to be an obvious part of aging, some experience the dip due to disorders of the testicles, brain, and pituitary gland that bring about hypogonadism. Other aspects like cancer treatments, injury to the testicles, stress, and chronic diseases can as well contributed to low testosterone production. Low levels of this key sex hormone in older men can attract health issues, such as sarcopenia, osteoporosis, as well as psychological symptoms. Doctors recommend testosterone drugs for such issues.

The FDA approved the use of testosterone replacement therapy specifically for men with low testosterone levels due to medical conditions that cause hypogonadism. Nevertheless, the FDA has stated that testosterone is being widely used in an attempt to relieve symptoms in men experiencing low testosterone levels for no other reason other than aging. The benefits and safety of this unapproved use of TRT have not been established yet.

Testosterone gels are applied once every day to intact skin of the upper arms, chest or shoulders. AndroGel accounts for 66 percent of the TRT gel prescriptions in the market. For years, AndroGel has been used to treat hypogonadism, a medical condition in which the body fails to produce enough testosterone. This condition is tested by observing testosterone levels in the blood. The tests measure the patient’s hormonal level and make it easy for the doctor to rule out other conditions.

Even with the requirements for prescribing testosterone drugs, it’s estimated that about one-quarter of the prescriptions are dispensed without a detailed blood test, and in most cases, there’s little or no re-testing after the first prescription. This lack of testing has created a loophole for the administration of testosterone products to patients who may not be suffering from hypogonadism, but just having low testosterone as a result of the natural aging process. The use of AndroGel has put many aging men at risk of experiencing pulmonary embolism, heart attack, or stroke.

Concerns About AndroGel Marketing

The increased use of AndroGel and other testosterone treatments has been met with increased concern surrounding their safety and efficacy. According to some physicians, few men are, in fact, diagnosed with clinical hypogonadism and the majority of symptoms of low testosterone levels are basically a normal part of the natural aging process. As such, a majority of the men who turn to AndroGel do so to boost their sex drive and energy levels.

Conversely, critics say that testosterone replacement manufacturers highly marketed Low T as a medical condition in order to increase profits. The advertisements claim that aging men may be “back in the swing of things” after the use of AndroGel. The manufacturer seized on the decline of testosterone as a marketing tactic meant to coerce men into wanting the treatment. The drugmaker’s aim was to convince men that feeling less sexual or being less active actually constitutes a new disease that should be cured with a prescription testosterone drug.

In 2012 alone, AbbVie invested approximately $80 million in marketing AndroGel and got around $1 billion in sales that year. This did not help the fact that many medical experts see AndroGel as being over-prescribed for low libido, which is not always effectively or safely treated with testosterone gels.  

Medical experts are concerned that the long-term benefits of the TRTs haven’t been properly studied and feel there should be more agreement concerning what institutes a normal testosterone level. The marketing campaigns did not warn users of adverse events. Adverse marketing of TRT to physicians and consumers has resulted in a boom for the manufacturers of these drugs. Moreover, since testosterone therapies like AndroGel are not proven treatments, critics caution that the risks of these products may be much higher than possible benefits for healthy men. Thousands of patients used AndroGel and experienced adverse reactions, but the drug and other similar testosterone treatment therapies are still being marketed to men by drug manufacturers.

Side Effects of AndroGel

Pharmaceutical companies that manufacture testosterone replacement drugs like AndroGel aggressively market their products, assuring men of increased strength, vitality, sex drive, and generally a better quality life. However, the reality is that TRT can cause several health issues that might not be worth the benefits. Several studies and clinical trials have linked AndroGel to serious health complications such as cancer and heart problems. Also, TRT can disturb the balance of hormones in the body. The drug may cause the testicles to shrink, posing a risk of irreversible infertility. Children, women, and pets may as well experience adverse reactions if they come into contact with testosterone replacement treatment products.

A U.S. Food and Drug Administration (FDA) advisory committee studied the risks associated with TRT. Evidence from their studies and expert input prompted the agency to require labeling to include additional risks linked to the use of these products. However, even with that, critics- including thousands of plaintiffs- insist that even more warnings concerning the side effects should be included.

Severe side effects are uncommon, but the side effects reported in clinical trials are typically minor. The most reported side effects of AndroGel included enlarged male breasts, reaction at the application site, changes in hair patterns and growth, and oily skin. Other side effects included in the original label included acne, back pain, prostate disorder, and abnormal lab tests.

Heart Attack Risk Associated with AndroGel

According to the results of a clinical trial published in the JAMA in February 2017, treatment of men with testosterone gel for a year was linked to a substantial increase of coronary artery plaque. This a condition in which a waxy substance builds up, hardens, and reduces the amount of oxygen flowing to the heart. If the artery is completely blocked, it can cause myocardial infarction (heart attack). For one year, researchers studied the effect of the TRT on cardiovascular health in men with low testosterone levels that could not be caused by another thing other than age. 138 men over the age of 64 were involved in the study to its completion. 73 of them received a testosterone drug, and 65 received a placebo. When compared with placebo, TRT was linked to a substantially greater increase in non-calcified plaque volume. The study’s authors also noted that larger studies were necessary to assess the risk comprehensively.

After starting TRT, the risk of heart attack significantly increases in men who had already been diagnosed with heart diseases, according to a 2014 study published in PLOS One. The findings of this study showed that testosterone drugs, such as AndroGel increased the risk of cardiovascular problems. The trials mostly constituted older men who used drugs for twelve weeks or more.

Blood Clot Risk

In June 2014, the FDA required AbbVie and other manufacturers of testosterone drugs to include a warning on drug labels concerning the risk of blood clots in veins. AndroGel contains a warning that using the drug could lead to severe blood clots. High levels of testosterone increase the production of thromboxane. This is a lipid responsible for promoting the constriction of the blood vessel. This can significantly slow blood flow, which creates conditions favorable for the formation of blood clots. When these clots form in a major vein, they can cause deep vein thrombosis. If they break free, these clots can travel to the brain and cause a stroke or to the lungs and cause a pulmonary embolism.

Polycythemia is another side effect of TRT. It is a condition characterized by increased levels of red blood cells. When too many red blood cells are produced in the bone marrow, the blood thickens and increases the risk of blood clots. A 2013 study in the Clinical and Applied Thrombosis/Hematosis found that the development of blood clots occurred as quickly as 3 weeks after starting TRT.

Increased Risk of Prostate Cancer

AndroGel is associated with a possible increase in the risk of prostate carcinoma. This was primarily due to a spike in testosterone levels. One study found that men who had their testosterone levels in the highest quartile faced double the risk of developing prostate cancer. Another study in the Journal of Urology analyzed cases involving men who went through therapy for sexual dysfunction. The study revealed that twenty men were found to have prostate cancer after starting therapy. In 55% of cases involving prostate cancer among men who were on TRT, doctors detected cancer within two years of the initial use. The rest of the men were diagnosed between 3 and 8 years after starting treatment.

Stroke Risk

In March 2015, the FDA required testosterone drug manufacturers to update their products labels to warn consumers of a potential increased risk of stroke. According to the agency, some post-marketing studies found that there was an increased risk in stroke associated with drugs such as AndroGel. According to a 2010 study in the New England Journal of Medicine, the drug could increase the risk of stroke in older men with a high prevalence of chronic diseases and limited mobility.

The FDA stated that it required pharmaceutical companies to organize clinical trials; the use of testosterone increased the risk of stroke. The agency also directed health care practitioners to warn their patients about the possible risk. The FDA further cautioned patients already using TRT drugs to seek medical attention as soon as they experience symptoms of stroke, such as slurred speech or weakness on one side or one part of the body.

AndroGel May Worsen Sleep Apnea

According to the drug’s label, AndroGel may worsen sleep apnea or increase the possibility of it developing, especially in patients with chronic lung disease or obesity. Some studies have found that testosterone replacement therapy may worsen a kind of sleep apnea referred to as obstructive sleep apnea (OSA), but others argue that there was a weakness in the association between the drugs and the sleep condition. With obstructive sleep apnea, airflow decreases or stops during sleep due to a narrow or blocked airway.  This can lead to atrial fibrillation, stroke, and cardiac ischemia, a condition where insufficient blood is flowing into the heart.

Other adverse side effects linked to AndroGel include:

  • Worsening symptoms of an enlarged prostate
  • Lower sperm count
  • Enlarged and painful male breasts
  • Swelling of the body, ankles, and feet
  • Increased risk of deep vein thrombosis occurring in the legs

AndroGel Black Box Warning

AndroGel is applied using a gel pump bottle.  However, reports have shown that the gel may have serious side effects in the event of accidental exposure to children. In September 2009, the FDA required AndroGel to have a black box warning about the risk of problems for children exposed to the testosterone gel. These include:

  • Early puberty
  • Aggressive behavior
  • Increased libido among children
  • Inappropriate growth of pubic hair
  • Changes in genital size
  • Other hormone problems

With continued concerns about the risk that AndroGel posed to children, a Medication Guide was developed in November 2011. It appears the manufacturer knew or should have known about the risk to children even before the introduction of the drug and could have taken additional steps to protect kids who may accidentally come into with AndroGel.

FDA Reconsiders, Orders Manufacturers to Update Their Labels

In 2014 and 2015, the FDA required all testosterone drug manufacturers to include heart attack and stroke risk warnings to the drug label. The agency also warned health care providers against over-prescribing the drug. The agency also required testosterone drug makers to clarify that the treatment was only approved for use in men with low testosterone resulting from a disease or injury. Doctors and patients should also be warned that TRT may increase the risk of cardiovascular issues, including stroke and heart attack. The agency stated that the original information provided by AbbVie and other testosterone manufacturers was vague enough that the companies marketed their products to healthy order men who experienced a decline in testosterone levels due to aging and who wanted to regain their youth.

Millions of men use testosterone treatments such as AndroGel because of the multimillion-dollar advertising campaigns describing the drugs as treatment for popular symptoms of aging like fatigue, low sex drive, and depression. Over the past several years, sales of these medications skyrocketed steeply into billions. As reported by Bloomberg, AndroGel alone brought in $934 million.

Public Citizen: FDA Delayed on Warning

The FDA’s decision to include warnings to TRT came after a year of investigations into cardiac risk. In January 2014, the agency first announced that it was investigating the risk of heart attack, stroke, and death in men using approved testosterone drugs. The agency found no evidence of risk at that time. The consumer watchdog Public Citizen supported the FDA’s move to investigate the drug but questioned an inexcusable delay in action. In February 2014, Public Citizen petitioned the FDA to add a black box warning to testosterone drugs. The group incorporated extensive evidence to support its request. However, the petition was rejected by the FDA 5 months later due to “insufficient evidence.’

In contrast, Canada’s FDA equivalent took action the day after the petition went out and issued a health warning in July. Public Citizen ties the FDA to the problem because they took longer to act and prevent more possible injuries from TRT. In September 2014, the FDA’s Bone, Reproductive and Urology Drugs Advisory Committee gave a 20-1 vote to support the revision of product labels by testosterone manufacturers such as AbbVie, and Eli Lilly & Co. The committee agreed that the companies need to review and update product labels to add stricter language clarifying what health conditions should be treated using the medications. Also, panel members agreed that drug makers should conduct more safety studies to eliminate the possibility of cardiovascular issues conclusively.

Mass Tort Against AbbVie

A string of mass torts followed shortly after the FDA’s first announcement concerning the risk of stroke, heart attack, and life-threatening problems associated with AndroGel. The mass tort action alleges that AbbVie did not warn thousands of men concerning the possible side effects of the Low-T drug. Over 7,000 lawsuits have been filed against TRT manufacturers. About 4,200 of those lawsuits target AbbVie’s AndroGel.

The gist of mass torts against AbbVie is that AndroGel increases the risk of major cardiovascular conditions through biochemical, coagulation, and rheological system effects that can potentially tamper with the integrity of blood flow. The drug manufacturing company has an obligation to warn of these issues, especially to men who had pre-existing cardiac conditions. AndroGel mass torts and other lawsuits have been consolidated as Multi-District Litigation (MDL) in the Northern District of Illinois. The cases are being heard by Judge Mathew Kennelly.

History of AndroGel Settlements

In the first trial in July 2017, a jury cleared AbbVie of liability after determining that AndroGel did not cause men’s heart attacks. However, the company was left on the hook for misinterpretation and negligence. The manufacturer was ordered to pay a Chicago man $150 million in punitive damages for misinterpretation of the drug’s use in its marketing campaign. There were no compensatory damages. However, in December 2017, the $150 million decision was vacated for being inconsistent, and a trial was scheduled to begin on March 2018. In May 2018, the jury awarded $3.2 million in damages.

The second trial settled in October 2017 with another jury awarding $140 million in punitive damages and $140,000 in compensatory damages to a Tennessee man who alleged he suffered a heart attack after AndroGel use. However, Judge Kennelly vacated the verdict on the grounds that it was inconsistent with instructions given. A new trial was ordered but has been halted by the settlement talks.

More than 4,000 federal AndroGel cases remain unsettled and more may be pending in local and state courts. However, AbbVie is on the brink of settling the lawsuits. In September 2018, the AndoGel manufacturer announced that an agreement on settlement terms between AbbVie and the plaintiffs was reached, but the final paperwork is yet to be executed.

AbbVie’s potential settlement comes after 6 federal bellwether trials, which has mixed outcomes. The company won in several cases, and the plaintiffs were victorious in the other cases.  AbbVie is the last testosterone manufacturer to settle in mass litigation in the Chicago federal court. Eli Lilly, which makes the testosterone replacement drug Axiron, announced a settlement in January; Endo International, the maker of Testim, settled in June; and Actavis, the Andoderm manufacturer, settled in July.

This move saw the judge issue a stay halting cases which had been scheduled. These are cases against AbbVie and other involved defendants, including Unimed Pharmaceuticals, Solvay Pharmaceuticals, and Abbott Laboratories, all of which previously owned AndroGel. The judge stated that the stay was to allow the involved parties to devote themselves to finalizing the agreement. The amount of settlement will be confidential, and the allocation will be made by a special master appointed by the court.

Find an AndroGel Mass Tort Expert Near Me

Men or loved ones who have been affected by taking AndroGel should seek legal advice. While lawsuits against the manufacturer are still pending, litigation will culminate at some point in the near future. So, it’s important to act quickly. Reach out to Consumer Alert Now to learn more about your legal options. We serve all areas of the United States, providing information and helping individuals who have been harmed by drugs like AndroGel get the justice they need through a mass tort action. Contact Consumer Alert Now at 800-511-0747 to get started.