AndroGel® Testosterone Attorneys FDA Testosterone Warnings & Safety Alerts: On January 31, 2014, the Federal Drug Administration issued a FDA heart attack and stroke warning for AndroGel® stating that federal regulators are investigating the link between testosterone therapy drugs and certain medical conditions. New research suggests treatments may cause an increased risk of stroke, heart attack or even death. What is AndroGel? AndroGel® 1% or 1.62% is a hydroalcoholic gel that is available by prescription only to treat hypogonadism, a medical condition that may impact as many as 5 million men in the United States. Normally, the production of testosterone is controlled naturally in the brain by the hypothalamus and pituitary glands. Testosterone levels between 300 ng/dL and 1000 ng/dL are generally considered in the normal range for an adult male. When T-levels fall below the normal, brain signals are supposed to stimulate the manufacture of the hormone in the testicles. If not, low-T can affect changes in a man’s fat distribution, mood, energy levels and muscle mass. Important Safety Information AndroGel® is available in a metered-dose pump or packets for easy application. According to manufacturer AbbVie Inc., the only area to which 1.62% testosterone gel should be applied is the shoulder and upper-arm area that would be normally be covered by a short-sleeved T-shirt. AndroGel® 1% can be applied to shoulders, upper arms or stomach but not to any other areas of the body. The manufacturer warns that the medication should always be applied on clean, unbroken skin. Since the active ingredient in AndroGel® can transfer to other people, the patient’s hands must be washed immediately following every application. Body areas where the drug is applied should also be thoroughly cleaned prior to unclothed contact with someone else. It is most important that women and children avoid direct contact with an unwashed or unclothed application site. If accidental contact with the application area occurs, the contact area should be washed immediately with soap and water. Side Effects of AndroGel® Use The most common side effects of AndroGel® include hypertension, mood swings, skin irritation at the application site, increase in red blood cells and an increased prostate-specific antigen count. Less common but more serious side effects may include: Breast Swelling or Tenderness Emotional Overreaction or Paranoia Frequent or Difficulty Urinating Swelling in Legs, Ankles or Feet Problems Breathing During Sleep Dizziness and/or Hot Flushes NOTE: As with any medication, there could be other side effects in addition to those listed above. For example, if you already have an enlarged prostate gland, signs and symptoms can get worse. Why are Low T symptoms sometimes misleading? Signs of low testosterone often are subtle and may be mistaken for natural signs of aging or other medical conditions. Generally speaking, someone with Low T may experience low sex drive, erectile dysfunction, lack of energy, increase in body fat, loss of muscle mass, irritability, lack of focus, decrease in bone density or loss of body or facial hair. However, the diagnosis of hypogonadism should be confirmed by blood tests, not symptoms. What should my doctor check for prior to prescribing AndroGel? Your healthcare provider should take a medical history and conduct an examination to determine if you have breast cancer or prostate cancer, heart conditions, kidney or liver problems, urinary problems, sleep apnea or other serious medical conditions. Prior to recommending replacement therapy, your doctor should order blood tests to know your exact hormone level. Can AndroGel interfere with my other medications? Yes. Testosterone therapy may affect those taking insulin, anti-blood clotting drugs and corticosteroids. It is important that your healthcare provider ask about all prescription medications as well as any non-prescription drugs and supplements that you may be taking prior to prescribing hormone therapy. Who should be excluded from using AndroGel? AndroGel® is not intended for women and must be avoided in those who are breast feeding, pregnant or may become pregnant. Any of these products can harm breast-feeding or unborn babies. In addition, men who have or might have prostate cancer or breast cancer should not be treated with the medication. Testosterone Therapy Lawsuits Our personal injury attorneys are currently following testosterone therapy litigation closely. Since most lawsuits are still in early stages, it is not clear as to what role the drug companies’ advertisements may have played in encouraging men to seek treatments. Additionally, the use of AndroGel® is only FDA-approved to treat specific medical conditions and not all causes of low T levels. Recent studies have suggested that some men who received prescriptions were never tested for low testosterone or failed to meet established medical criteria. If you or a loved one were prescribed AndroGel® and suffered serious medical conditions like a heart attack, stroke, blood clots, liver damage or even death, you may be entitled to seek compensation for your damages. Contact Harrell & Harrell at 904-251-1111 or 1-800-251-1111; or use this website’s Do I Have A Case form for a prompt response. Our personal injury lawyers can document and quantify the damages for compensation of medical expenses, hospital bills, lost income, pain and suffering, future healthcare costs and any lasting disabilities.