In recent months, a growing number of lawsuits have been filed by former Bio-T-Gel users who allegedly developed blood clots after undergoing treatment with this product. Bio-T-Gel is a widely-prescribed testosterone supplement made by BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals. Symptoms of a Bio-T-Gel blood clot may include pain, redness, warmth, and swelling at the site of the clot.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered a blood clot after using Bio-T-Gel, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Bio-T-Gel and we can help.
What’s the Problem With Bio-T-Gel?
Bio-T-Gel is one of the most popular testosterone replacement therapy (TRT) products on the U.S. market today. Unfortunately, despite its widespread usage, recent lawsuits have been filed against the drug’s manufacturers’ alleging that Bio-T-Gel caused blood clots and other serious side effects. Some experts believe that many more Bio-T-Gel Lawsuits will be filed around the country in the coming weeks, months and years.
Bio-T-Gel Blood Clot Risk
Medications used for the treatment of low testosterone (‘Low T’) should carry stronger warnings about the risk of blood clot and other severe cardiovascular complications, the consumer watchdog group Public Citizen said in February 2014. Public Citizen has petitioned the FDA to add a black box warning, the most serious warning allowed by law, to the labels of Bio-T-Gel and other similar products.
TRT has received approval from the FDA for males who have low or non-existent testosterone levels along with a clinically-diagnosed medical condition such as a genetic failure of the testicles to produce testosterone. Symptoms of Low T include:
- Loss of libido
- Decreased muscle mass
According to Public Citizen, approximately 25% of men who are prescribed testosterone supplements like Bio-T-Gel did not have a blood test to determine if their T levels were low. The group said its petition letter was based on mounting evidence of the risk of blood clot, heart attack and other adverse health consequences from research dating back to 2010, as well as a recently published analysis of 27 studies going back more than two decades.
Of the 27 studies, 14 that were not paid for by the pharmaceutical manufacturing industry identified a “highly significant” increased risk, Public Citizen stated. The 13 studies that were funded by drug companies all found no increased cardiovascular risk.
FDA Warning on Testosterone
In January 2014, the FDA issued a warning stating that it was investigating the risk of blood clot, stroke, heart attack and sudden death in testosterone users based on the publication of 2 studies which suggested an increased cardiac risk. In response, the FDA stated that testosterone had not been conclusively proven to increase the risk of cardiovascular complications. Senior adviser at Public Citizen’s health group Dr. Sidney Wolfe said the agency’s statement was “reckless” and “a betrayal of the FDA’s role as an agency in the U.S. Public Health Service.” “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” he said.
Blood Clot Symptoms
Symptoms of a Bio-T-Gel blood clot depend on where the clots originates. For example, symptoms of a clot in the heart or lungs may include chest pain, shortness of breath, and upper body discomfort in the arms, back, neck, or jaw. These symptoms may be indicative of a heart attack or pulmonary embolism.
- Symptoms of a blood clot in the veins of the leg typically include varying degrees of pain, redness, warmth, and swelling at the site of the clot. These signs may suggest a deep vein thrombosis, or DVT.
- Symptoms of a blood clot in the brain include unusual headache, speech changes, paralysis, dizziness, and trouble speaking or understanding speech. These signs may suggest that the patient is having a stroke.
Do I Have a Bio-T-Gel Blood Clot Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Bio-T-Gel Lawsuits. We are handling individual litigation nationwide and currently accepting new Bio-T-Gel Blood Clot cases in all 50 states.
Free Bio-T-Gel Blood Clot Lawsuit Evaluation: If you or a loved one suffered a blood clot after using Bio-T-Gel, you should contact our law firm immediately. You may be entitled to compensation by filing a Bio-T-Gel Blood Clot Suit and we can help.