A lot of men are uncomfortable talking about their health problems—especially when sex is involved. And that may explain why so many men don’t realize that hypogonadism, when the body produces too little of the hormone testosterone, is a fairly common ailment.
Almost all men produce less testosterone as they grow older. For some men, the drop is sudden and can cause uncomfortable symptoms, such as sweating, decreased libido, or enlarged breasts. This has opened up an opportunity for pharmaceutical companies to develop topical testosterone replacement and supplement medications. These are creams or ointments that can be absorbed through the skin to replenish a man’s testosterone levels.
According to the U.S. Food and Drug Administration (FDA), topical testosterone products represent approximately 65.6 percent of all testosterone prescriptions dispensed. Several drug manufacturers are competing in this profitable market. Today, we’ll focus on one: Axiron, introduced in 201 by the drug manufacturer Eli Lilly & Company.
Basic Facts About Axiron
Axiron topical testosterone that is applied under the armpits. Although one may relate it to roll-on deodorant, the application is a little more complex. The medication itself is an alcohol-based liquid, and therefore, cannot be simply rolled on. Instead, patients fill a designated cup with the solution and then gently rub the cup’s rim over the armpit. The testosterone slowly pours over the rim and onto the armpit, while the rim massages it into the skin.
Over the years, doctors and patients have had success with this brand of testosterone supplement. However, on January 31, 2014, the FDA issued a statement warning that the use of Axiron had shown significant side effects. In addition to correcting hormonal shifts, this drug appeared to be responsible for causing health risks that ranged from inexplicable weight gain to blood clots and pulmonary embolisms.
Once the FDA report was made public, dozens of Axiron users came forth with allegations against the drug and Eli Lilly & Company. These claims included accusations against the company itself as well as the potency and effects of the drug.
Among the allegations:
- Eli Lilly valued profit over patient safety. The company did not adequately warn consumers or physicians of the risks associated with the use of its drug.
- Eli Lilly failed to research the risks. The company did not sufficiently research the safety of the drug before introducing it to the market and marketing its use among the medical community.
- Eli Lilly marketed Axiron for people who did not suffer from the medical conditions the drug was designed to treat. The company used frequent advertisements to encourage men to seek low testosterone treatment, when in fact many such men had no medical need for treatment.
- Eli Lily failed to comply with labeling standards. Several of the lawsuits currently underway allege that the manufacturer should have more clearly identified the risks of the drug, which would have prevented the injured patient from taking it.
Serious and Fatal Consequences After Using Axiron
Ointments, lotions, and creams sometimes present challenges as delivery systems for medicine. They’re goopy: it’s easy for the medication to accidentally be squirted from the tube and touch the skin of someone other than the patient. Testosterone medicines make this sort of accidental contact not merely unpleasant but downright dangerous: Axiron and other testosterone medicines must not come in contact with the skin of any woman or any child before puberty.
In an attempt to limit the transfer effects of lotions, Eli Lily developed the armpit-cup application. However, for the testosterone solution to have the same effect on a smaller area of the body, as opposed to the chest and back, it needed to have double the potency (1% to 2%). In addition to failing to make the potency change readily known, accusers claim that the increased concentration directly contributes to an increased risk for developing:
- Blood clots. Testosterone can cause an abnormal increase in the number of red blood cells (polycythemia) in your body, which in turn can facilitate clotting. As a result of the increased clotting risks, the FDA now requires that all testosterone products provide a general warning regarding blood clots.
- DVT. Blood clots can form in the legs; when those clots block blood flow deep in the legs, the condition is called deep vein thrombosis (DVT). DVT can be extremely painful, and the clots run the risk of traveling up the legs and into the brain, heart, and lungs.
- Stroke. Blood clots can prevent vital nutrients and oxygen from reaching the brain, which can cause tissue and neurons to die. The resulting brain damage and loss of abilities is often permanent.
- Heart problems. If blood clots block the blood vessels that bring oxygen and nutrients to the heart, heart cells die and the organ stops functioning properly. The results can range from arrhythmias (dangerous changes in heartbeat rhythm), tachycardia (racing heartbeat), or atrial fibrillation and heart failure.
- Pulmonary embolisms. A pulmonary embolism occurs when there is a sudden blockage of an artery in the lungs. In most cases, the blockage is caused by a blood clot. While some pulmonary embolisms are small and not necessarily life-threatening, even small clots can cause permanent lung damage. In more severe cases, the pulmonary embolism can completely block the artery and lead to death if not immediately treated.
Symptoms and Treatment
The major concern of testosterone applications is the increased risk of blood clots. Since clots can form in and travel to any part of the body, constricting blood flow and increasing organ damage, it’s important to not only understand the risks but also to be able to identify the potential signs of a clot. These symptoms include:
- Sudden shortness of breath (pulmonary embolism).
- Coughs that produce pink or bloody mucus.
- Sharp pain in the chest, legs, or arms (clot in the extremities).
- Elevated or excessive heart rate (heart trying to increase blood flow to clear the blockage).
- Lethargy and fatigue (lack of oxygen to the brain).
- Blurred vision.
Common treatment options to remove or shrink blood clots include:
- Anticoagulants. Patients may be treated with blood thinners to prevent clots from growing. Anticoagulants also allow blood to circulate faster and flush the veins of any clot debris. However, it may take some time before the blood can be thinned effectively. As a result, secondary medications may be required.
- Monitoring. Patients taking anticoagulation medications may require regular blood tests and monitoring to look for the risk of bleeding caused by the medication.
- Thrombolytic therapy. In some cases, patients may require a medication designed to break up blood clots. This is known as thrombolytic therapy. This is used in potentially dangerous situations where the patient is at risk of death from the blockage.
Pharmaceutical companies are legally required to test and inspect their products thoroughly to ensure that their patients will not be harmed. If an unsafe drug makes it to the market and someone suffers as a result, you’re entitled to expect that those responsible will be held accountable.
Whether it’s Eli Lily and Company or another pharmaceutical manufacturer, these companies look at everyone in the United States and see dollar signs. As a result, they repeatedly put profits over people. At Kennedy Hodges, L.L.P., our first priority is making things right for you and your family.
Although we no longer accept Axiron cases, if you’ve suffered as a direct result of another dangerous drug or device, you don’t need to face the pharmaceutical giants alone. Contact our team of board certified attorneys now by clicking on our live chat feature or calling us toll free at 888-526-7616 for a FREE, no obligation case review.