FDA Panel Supports Limits on Testosterone Drugs

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 and patches.

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 Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national class action lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.