Testosterone Therapy Attorney About 5 million prescriptions are written each year for testosterone therapy. Many men who suffered from Low T and hypogonadism have been helped by hormone replacement products. However, the U.S. Food and Drug Administration has issued warnings to drug manufacturers, healthcare providers and patients that due to the results of recent studies, these medications could cause an increased risk of stroke, heart attack or death. Studies have also shown that men who already suffer with heart problems had an elevated risk when compared to those who did not. The manufacturer of one of the most popular brands used for replacement therapy recently issued a broader warning that their hormone replacement drug could cause serious medical problems for men who have heart, kidney or lung disease. Testosterone is an essential hormone for the development of masculine characteristics. As a side effect of the natural aging process, hormone levels can change due to someone’s genetics, drug treatments such as chemotherapy, the onset of type 2 diabetes, or simply by a lack of production in the testicles. When the brain and the testes work in unison, the normal range for T levels is between 300 ng/dL and 1000 ng/dL. Since this hormone plays such an important role, changes in production can dramatically affect a man’s energy level, sexual desire, muscle mass, strength and fat distribution. Early studies funded by major pharmaceutical companies concluded there was no increased risks associated with using testosterone drugs. At the Law Offices of Harrell & Harrell, our personal injury attorneys are tracking to see if unnecessary dangers were caused by the pharmaceutical companies’ aggressiveness in market positioning and new product campaigns. Some suggest their direct-to-consumer advertising may have been a contributing factor to possible misuse of replacement therapy drugs. Rumors have also surfaced that certain drug companies may have known through their own research that using their product was risky but did little or nothing to inform consumers. However, the FDA does recommend that anyone on a treatment plan should continue to take their medication as prescribed until they can discuss any concerns with their doctor. Determining Who Has Liability for Damages A study published in the Journal of the American Medical Association in November 2013 linked testosterone therapy products to serious side effects including heart attack, stroke and death. This has caused personal injury attorneys to begin investigating problems within the industry. From overly aggressive marketing strategies to a failure to provide adequate warnings for patients and healthcare providers, testosterone therapy litigation lawsuits will likely continue to rise with the accelerated use of the hormone replacement gels, injections, transdermal patches, buccal systems and sprays. The FDA has already warned medical providers about the risks associated with off-label use of products approved for treatment of hypogonadism. The manufacturers and licensed distributors of the following brand names may have liability for injuries documented in a testosterone lawsuit including: AndroGel: Lawsuits have been brought against manufacturer AbbVie, a subsidiary of Abbott Laboratories, for overpromoting the use of AndroGel to men who were not suffering from hypogonadism as well as failing to provide adequate warnings about known risks. In addition, medical experts have suggested the benefits of drug may have been overstated as the maker’s increased their advertising expenditures more than 500% to promote their products. AndroDerm: Watson Pharmaceuticals (now Actavis, Inc.) was one of the first manufacturers to gain FDA-approval for their hormone replacement products. Testosterone patch lawsuits have been brought against Actavis for failing to warn medical providers and men who were using the products about potential risks. The drug maker advertised the transdermal patch to be safer than regular gel products. However, recent studies suggest men have the same risk factors as those using other delivery types. Axiron: Developed by Acrux, an Australian pharmaceutical company, and approved in 2010, the product is marketed in the United States by Eli Lilly & Company. The topical solution is applied to the armpits with a reusable cup applicator. Special care should be taken in cleaning, storing and disposing of the product to avoid accidental exposure in women, children and pets. Bio-T-Gel: Approved in February 2012, this once daily transdermal gel was developed by BioSante Pharmaceuticals and later licensed to Teva Pharmaceuticals. 50 mg of endogenous androgen is applied to dry skin on the shoulders or upper arms for 24-hour delivery from a single application. By comparison, the product is not heavily used. Delatestryl: An injectable hormone replacement product, Delatestryl received FDA approval in 2003. Manufactured by Savient Pharmaceuticals, it is also marketed under the brand name Tesamone as a testosterone injection that is injected into the buttocks every 1 to 4 weeks. Depo-Testosterone: This intramuscular agent was introduced by Pfizer in 2003, but has been used for a long time to treat men with Low T. A generic version of the hormone injection was approved in 2013 under an ANDA (Abbreviated New Drug Application) submission. Foresta: Manufactured by Endo Pharmaceuticals, this spray gel was approved by the FDA in December 2010. The product is applied to the front and inner thighs once a day. The product does warn that the gel spray is not intended for use in women or males under the age of 18 years. Striant: The developing pharmaceutical company, Actient Holdings LLC., was purchased by Auxilium Pharmaceuticals in April 2013 who currently markets the sustained-released buccal system. Small patches containing the hormone are placed between the cheek and gum just above the incisor tooth – one in the morning and one in evening following routine dental care. Testim: Testim 1% is one of the most widely used products to treat hypogonadism and Low T levels in men. The U.S. Food and Drug Administration issued a black box warning to Auxilium Pharmaceuticals in 2009 requiring the manufacturer to include explicit warnings about risk factors associated with replacement therapy drugs. Testopel: Manufactured by Slate Pharmaceuticals, the hormone replacement product was initially developed in the 1970s but was not FDA-approved until 2008. The testosterone implant is placed under the skin and releases the medication over a period of 3 to 6 months. With a five-fold increase in the number of prescriptions written each year, big pharmaceutical companies are positioned to make billions off this niche healthcare market. Prior to the release of several recent studies, many doctors were unaware of many of the risks involved. Today, the entire medical community has been warned about the risks associated with various treatment plans as well as those groups of men who are at increased risk because of heart conditions, prostate cancer and liver problems. Conversation with Your Healthcare Provider If you have symptoms of Low T, the most important first step is to make an appointment with your doctor to discuss your specific medical condition. The changes that you may have been experiencing could be natural signs of aging and only a healthcare provider can order the blood tests that accurately measure your testosterone levels. This is the fastest way to rule out related conditions such as signs of aging and diagnose hypogonadism as the actual cause of your problems. You will also be able to discuss what treatment options are available to manage your condition. Don’t be surprised if diet, exercise and a change of lifestyle are prescribed along with options for medical therapies for hormone replacement. Maintaining T levels in the right range can be very important to how a man feels, retaining muscle strength and controlling the distribution of body fat as well as his sex drive and sexual performance. However, there has been an alarming number of cases involving testosterone therapy litigation where the injured party did not suffer from hypogonadism and medication was prescribed in hope of reversing some signs of premature aging. The U.S. Federal Drug Administration has issued FDA warnings to manufacturers, distributors and the medical community that these drugs have not been approved for off-label applications. If you or a loved one suffered with heart attack, stroke, prostate cancer, kidney or liver damage while taking hormone replacement products, contact the Law Offices of Harrell & Harrell at 904-251-1111 or 1-800-251-1111 for a free consultation to review your case.