In September, a Food and Drug Administration panel of experts voted to
impose strict limitations on testosterone drugs-and the testosterone drug
industry. In recent years, testosterone replacement therapy has exploded
into a multi-billion dollar industry-at the expense of consumer health.
The FDA now wants to step in and tighten labels for these medications.
They want to see these Low-T prescription drugs only prescribed for men
with serious medical conditions, such as pituitary gland problems. In
recent years, testosterone replacement therapy has been used to combat
a number of perfectly normal “aging” symptoms, such as low
libido and fatigue.
Everyone is looking for the fountain of youth-and drug companies are well
aware of this. As such, they began marketing low-t drugs to middle-aged
men in their 40’s and 50’s who were suffering from a natural
decline in testosterone production. This natural decline can have symptoms
such as low libido, decreased energy, and difficulty concentrating. This
resulted in over 2.3 million men being prescribed low-testosterone gels
The benefits of testosterone treatment for normal, healthy men has not
been fully evaluated and has since been linked to higher incidences of
heart disease, heart attacks, strokes, and even death. If the FDA does
adopt the panels’ suggestions to limit testosterone use, this would
drastically reduce the number of men who are prescribed testosterone therapy
replacement drugs. It would also limit coverage from insurance companies
and prevent drug companies from using certain types of marketing campaigns.
The FDA panel was asked to review evidence of low-t drugs’ safety
risks, as well as any benefits. What they found was that many doctors
prescribe these drugs to patients who have not even undergone a full testosterone
workup to determine if they do have low testosterone. In fact, up to 25%
of men taking low-testosterone drugs had not even had a baseline test
of their testosterone levels and 60% of men were just under the care of
their primary physician and not an endocrinologist.
The National Institute of Health is about to sponsor a trial test to see
if testosterone therapy does improve physical and sexual functioning in
normal healthy men. It will also evaluate the risks associated with heart
disease, strokes, and diabetes.
Low Testosterone Therapy Litigation
In the past year, over 150 testosterone lawsuits have been filed on behalf
of U.S. plaintiffs. These cases have been consolidated into a multidistrict
litigation in U.S. District Court, Northern District of Illinois. Men
who have been harmed by taking low-t drugs are urged to consult with their
physician and an attorney to review their options.
National Class Action Pharmaceutical Lawyers
If you or a loved one has suffered any serious side effects from the use
of testosterone replacement therapy products, you have a right to seek
justice. To learn more about your legal options or to schedule a free
consultation call the
Philadelphia class action lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national class action lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.