Sullivan & Brill, LLP is accepting clients that have suffered heart attack, stroke, pulmonary embolism, deep vein thrombosis, death, or other serious cardiac complications after undertaking testosterone therapy. Treatments for "low testosterone" have been tied to growing controversy. In scientific studies, testosterone has been associated with an array of serious side effects. In January of 2014, the U.S. Food and Drug Administration (FDA) issued a " Drug Safety Communication" indicating that it is reviewing the cardiac effects of Testosterone on men and one consumer advocacy group is fighting for increased safety warnings on the products.
Testosterone Lawsuits Mounting
On June 6, 2014, the Judicial Panel on Multi-District Litigation consolidated the nationwide litigation concerning testosterone therapy drugs before Federal District Court Judge Matthew F. Kennelly in the Northern District of Illinois. The consolidation is industrywide and includes anyone that was injured by taking testosterone replacement therapy regardless of what company manufactured the drug. As of the date of the order, 45 cases were pending in 4 federal courts. However, it is anticipated that the litigation will eventually include thousands of cases.
The FDA's announcement has been followed with at least four lawsuits brought over the testosterone drug, AndroGel, that have been filed in the U.S. District Court, Northern District of Illinois. All four of the men bringing these lawsuits similarly allege that it was their use of the testosterone medication, AndroGel, that caused them to suffer heart attacks, heart failure, and stroke. All of the men who made the allegations also allege that they had no prior history of cardiac disease, heart attacks, heart failure, and stroke. Our lawyers at Sullivan & Brill, LLP believe that the manufacturers of AndroGel and other testosterone therapies failed to adequately warn physicians and consumers of the cardiac risks associated with testosterone therapies.
The FDA explains that testosterone is a hormone necessary to the development of male growth and masculine characteristics. To date, testosterone products are only approved by the FDA for use in men who either lack testosterone or who have low testosterone levels tied to a related medical condition.
The FDA's recently issued "Drug Safety Communication" included information on its investigation of increased stroke, heart attack, and death risks in men who are taking FDA-approved testosterone products, including AndroGel. The FDA also wrote that it is reviewing risks for cardiac issues and death tied to FDA approved testosterone products. The FDA is re-assessing these health risks following the publication of research on testosterone products for approved uses. Separately, the two studies suggest increased risks for cardiovascular events in men receiving testosterone therapy.
Injuries associated with testosterone medications include:
- Deep vein thrombosis (DVT)
- Heart attack
- Pulmonary embolism
- Cardiovascular injuries
Testosterone treatments are delivered by skin patches; short-acting injections; topical gels; and what is known as a buccal system, which is application of the medication to the upper gum or inner cheek. Testosterone treatments are known by the brands AbbVie Inc.'s AndroGel, Androderm, Axiron, Bio-T-Gel, and Delatestryl.
Studies Reveal Increased Risk of Cardiovascular Damage
Two studies have been conducted on the increased risk of testosterone products and cardiovascular disease in men, one published by the Journal of the American Medical Association (JAMA) in November 2013, and the other published by the journal, PLoS One , in January 2014 . The researchers in both studies suggest that an increased risk of cardiovascular events may occur in men who are taking testosterone therapy.
The first of the two studies, published in JAMA, involved older men, and revealed an increased risk for stroke, heart attack, and death in men prescribed and taking testosterone therapy. Most, according to CBS News, were diagnosed with pre-existing heart diseases. An increase of 29 percent for heart attack, stroke, or death was seen in men taking testosterone. "We certainly now have to take a pause and say, 'Listen, we need long-term data before we tell a 40-year-old with low T to go on this medicine,'" CBS News contributor Dr. David Agus told "CBS This Morning."
The second study was published in the journal PLoS One, and also suggested an increased risk of heart attack in older men, and in younger men with pre-existing heart disease, who were taking a testosterone treatment. The study, conducted at UCLA and involving 55,000 men, revealed that the risk for heart attack doubles in men over 65 years of age within the first 90 days of taking testosterone, according to CBS News. That risk triples in men under the age of 65. "Testosterone increases red blood cell production and red blood production can lead to cells that coagulate," study co-author and UCLA epidemiologist Dr. William Finkle, told CBS Los Angeles. "Although testosterone products contain many warnings," said Dr. Finkle, "none of those warnings mention increased risks for heart attack."
According to the team, their findings were consistent with issues raised in three other recent studies that involved men in the same age range. The researchers also found that a more rapid increase with age was seen in the prevalence of both diagnosed and undiagnosed coronary artery disease based on autopsy studies, according to CBS News.
Consumer advocacy group, Public Citizen, indicated that a review of 27 different testosterone trials that was published last April, revealed that 13 industry-funded studies did not reveal any increase in adverse cardiac events; however, 14 studies that were not industry-funded revealed a two-fold increased likelihood for cardiac issues when compared to men not taking testosterone, CBS News reported.
Consumer Advocacy Calls for Increased Warnings on Testosterone Products
Consumer advocacy group, Public Citizen, is urging the agency to call for increased warnings about these risks on drugs prescribed to treat low testosterone. In fact, on February 25, 2014, Public Citizen petitioned the agency to add a "Black Box" warning - the agency's most serious warning - to the drugs' labels.
According to the FDA, no testosterone product is approved for use in men who are diagnosed with low testosterone that is not linked to a medical condition. Medical conditions include the genetic failure of the testicles to produce testosterone, according to a prior Reuters report. As of January of 2014, the FDA also indicated, despite studies indicating otherwise, that, "At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death."
"In the face of this accumulating evidence, this statement is reckless and is a betrayal of the FDA's role as an agency in the U.S. Public Health Service," Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a press release regarding the continuing lack of a Black Box warning on most testosterone products. "It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks."
Also according to Public Citizen, more than five million prescriptions for testosterone treatments were filled in 2013 in the United States. Dr. Sidney Wolfe noted that, should the FDA continue to not include Black Box warnings about heart risks associated with testosterone hormone replacement therapy, more unnecessary heart attacks may be seen. The FDA's Black Box warning is the strongest warning the agency may mandate companies to place on their products and alerts consumers that the drug is associated with a high risk of adverse events that, in some case, may be fatal.
"At the current rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country," Wolfe said. "Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks," he added, according to Reuters.
Public Citizen also asked the FDA to delay its decision on the long-acting injectable testosterone product, Aveed, also because Aveed does not have a Black Box warning.
Aveed by Endo International Receives Approval in 2014
In 2014, the FDA approved Endo International Plc's Aveed to treat male hypogonadism. The Aveed testosterone replacement therapy had been rejected by the FDA on three prior occasions, the last rejection occurred in May 2013.
Male hypogonadism is a condition that develops due to low testosterone production. Testosterone is the body's male hormone and is involved in maintaining body bulk in men, male sexual function, and bone growth. When men suffer from low testosterone, they may experience a reduction in libido, depression, and fatigue, according to a prior Reuters report.
Last May, when the FDA rejected Aveed for the third time, the agency indicated that an improved plan was needed by Endo for Aveed to indicate that the drug maker had managed risks associated with the long-acting treatment. Risks involved post-injection reactions and risks associated with castor oil – a component of Aveed – leading to blood vessel blockage in the lungs.
Aveed is a long-acting, so-called "depot" formulation (sustained release) of testosterone delivered in a combination of castor oil and benzyl benzoate. The FDA is requiring Aveed's label contain a boxed warning about risks for serious pulmonary-oil micro-embolism (POME) and anaphylaxis. Aveed will only be available through a restricted distribution known as a risk evaluation and mitigation strategy (REMS) so that Aveed is only used in men for whom Aveed's benefits outweigh its risks, according to Medscape.
Considering a testosterone lawsuit?
If you experienced complications as a result of testosterone treatment, you may want to consider filing a lawsuit. You can seek compensation for medical expenses, lost income, or pain and suffering due to injuries resulting from defective drugs.