Axiron® Testosterone Attorneys FDA Drug Approval & Risk Mitigation: Axiron® is to be applied to the armpits only. Do not apply the medication to any other parts of your body such as your stomach area, penis, scrotum, shoulders or upper arms. Women and children should avoid contact with any unwashed or unclothed area as the topical solution can transfer from your body to others. What is Axiron? Axiron® was approved by the Food and Drug Administration on November 23, 2010 as the only underarm testosterone replacement therapy for certain conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). For an adult male, when normal T levels (1000 ng/dL to 300 ng/dL) drop, the brain triggers the testicles to produce more of the hormone. Other FDA-approved types of testosterone therapies include: buccal tablets, subcutaneous pellets, transdermal patches, injections and topical gels. Important Safety Information Developed by Acrux, an Australian pharmaceutical company, and marketed in the U.S. by Lilly USA (Eli Lilly & Company), this replacement drug is a prescription medicine used to treat adult males with Low T-levels. The safety and efficacy of using the hormone replacement therapy in males younger than 18 years of age has not been established and improper use may affect bone growth in adolescents. The topical solution is applied to the armpits only and should not be applied using your fingers or hands. Before applying the hormone gel, it is important to check for broken skin as well as to make sure that your armpits are clean and dry. Since the topical testosterone solution is flammable, it is critical to let it dry before smoking or exposing treated areas to an open flame. The medication is applied in measured doses using pump actuation and a reusable applicator cup. Axiron® is classified as a CIII-controlled substance as it may be abused by someone who misuses prescription medicines. Side Effects of Axiron Use Some side effects of Axiron® include irritation at the application site, increased urination with feelings of urgency but often a weak urine stream, increased red blood cell count, higher levels of antigen used to screen for prostate cancer, and erections that can last a long time. Other adverse effects may include: Headache, Diarrhea or Vomiting Enlarged or Painful Breasts Problems with Sleep Apnea Increased Risk of Prostate Cancer Blood Clots in the Legs Swelling in Ankles, Feet or Body NOTE: Your doctor should check you for prostate cancer and other prostate problems before you start testosterone therapy as using hormone replacement drugs can possibly increase your risk of prostate cancer. How should Axiron be stored? You should always take special care in storing and handling the pump actuated bottle and applicator cup. Since the topical solution is flammable, The gel product should always be stored or disposed of safely. It is also very important to prevent accidental exposure of the solution to pets or children. What should my doctor check for prior to prescribing Axiron? Your healthcare provider should review your medical history and check for prostate problems as well as cancer before you start and while you are using Axiron®. Stop using the hormone replacement drug and call your doctor if you notice any ill effects or experience severe pain, swelling or redness. How should I use the replacement drug? It is important to use any testosterone therapy medication exactly as your doctor prescribes. Your healthcare provider will tell you how much to apply and how often to use it. The medication should be applied to the armpits at approximately the same times every day. Who should be excluded from using Axiron? Axiron® must be avoided in those who are breast feeding, pregnant or may become pregnant as the hormone replacement can be harmful to breast-feeding or unborn babies. In addition, young children who are accidentally exposed can develop early signs of puberty. Testosterone Therapy Lawsuits The personal injury lawyers at Harrell & Harrell are currently investigating legal claims regarding men who suffered a stroke, heart attack or even died while taking testosterone treatments. Symptoms of Low T levels are difficult to distinguish from those associated with the natural process of aging. For that reason, your doctor should have checked for underlying medical problems that may have been contributing to your condition as well as ordering blood tests to confirm your testosterone level. None of the FDA-approved products are cleared for use in men who lack an associated medical condition. A study published in the Journal of the American Medical Association is the second major study that has reported an elevated health risk related to testosterone therapy. If you or a loved one were prescribed Axiron® and suffered serious medical conditions like a heart attack, stroke, organ damage, dangerous blood clots or death, you or your immediate family members may be entitled to seek compensation for your damages. Contact the Law Offices of 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.