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,
, 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
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
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,
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. To learn more,
contact us today. Sullivan & Brill, LLP offers
free consultations and, if we cannot get a recovery for you, you do not owe us any attorney fees.