Axiron is one brand of many medications designed to treat low testosterone in men. Axiron is applied as a roll-on underarm solution, much like a deodorant product. The product delivers testosterone through the skin, and it is thought to address health issues associated with low testosterone. Other brands of testosterone medications are administered differently, e.g., intravenously by injection.
The symptoms of low testosterone can include loss of muscle, decreased sex drive, and loss of ambition, which are some of the characteristics related to traditional male functions and roles. Axiron does not enhance athletic performance and is not supposed to be used for that purpose.
The Axiron brand of topical testosterone solution has been withdrawn from the market in the U.S., although it was not withdrawn for safety reasons or reasons involving its efficacy. Generic equivalent drugs are still available.
Are Any Warnings Associated with Axiron?
There are numerous warnings associated with Axiron. For example, women should not use Axiron. The use of testosterone by a pregnant woman can cause congenital disabilities in an unborn baby. A pregnant woman should try not to have contact with the solution or the area of a man’s skin in which Axiron has been applied. If a woman has contact with Axiron, she should wash the place of contact with soap and water immediately.
The main warning for men is that Axiron and other similar medications can increase the risk of major adverse cardiovascular events, including myocardial infarction, heart attack, stroke, and cardiovascular death.
A person should not use Axiron if they have prostate cancer or male breast cancer.
A person should call a doctor if another person, especially a child, who is close to them develops certain characteristics, e.g., enlarged genitals, premature pubic hair, aggressive behavior, male-pattern baldness, excessive body hair growth, irregular menstrual periods, or any signs of male characteristics.
It should be noted that some side effects go away eventually as a person’s body adjusts to the drug.
However, other side effects can be dangerous and irreversible. A person should never use more than the dose prescribed by their doctor. Currently, however, doctors should not prescribe Axiron because it has been removed from the market in the U.S. As always, a person should not share or give medicine that has been prescribed for them to any other person.
Are There Any Health Risks Associated with Axiron?
Recent studies suggest that testosterone drugs such as Axiron may be associated with very specific side effects. These include:
- Heart Attack: Taking Axiron is associated with an increased risk of a heart attack;
- Stroke: Taking Axiron is associated with an increased risk of stroke;
- Deep Vein Thrombosis: This is a blood clot that develops in one or more of the deep veins in the body, usually in the legs. Deep vein thrombosis can cause leg pain or swelling, but on occasion, there are no symptoms;
- Blood clots: Blood clots may be harmless, but a risk is that a clot will travel to the lungs or the heart, and there they can be fatal;
- Blood Pressure: Various blood pressure-related conditions
Any of these conditions are potentially fatal.
In addition to these side effects, testosterone treatments, in general, may lead to other side effects. Some of the more notable side effects are the following:
- Blood Lipids: There may be changes in a person’s blood lipid profile. Lipids are fats in the blood. High lipid levels increase a person’s risk for heart disease, heart attack, and stroke. A lipid profile is the result of a blood test that shows total cholesterol in a person’s blood, their LDL or bad cholesterol; HDL or good cholesterol, and triglycerides, another type of fat;
- Acne: Acne is a skin condition that occurs when the hair follicles on the face become irritated from oil and dead skin cells. It causes skin blemishes. It is a condition that is most common in teenagers, but it can affect people of all ages;
- Hair Growth: Exaggerated or inconsistent hair growth on the face;
- Enlarged Breasts: Enlarged breasts in males;
Injuries associated with using Axiron are more common in men 60 and older who have taken the drug for several years.
What Are the Legal Issues Associated with Axiron Lawsuits?
Axiron was first approved by the federal Food and Drug Administration in 2010 for prescription use only to treat adult males with low or no testosterone. While Axiron was approved only to treat low testosterone, it was marketed as a sex-boosting aid to men who did not require testosterone boosts or replacement therapy. Numerous reports of serious side effects and thousands of lawsuits followed this.
One lawsuit was filed by a resident of Oregon who started taking another product, similar to Axiron, with the brand name “AndroGel” in 2008. At that time, the drug was marketed as a treatment for “Low T,” a non-existent medical condition, which is, in fact, only normal age-related symptoms such as low muscle tone and reduced libido. The man suffered a heart attack after taking the medication for 4 years.
He filed a lawsuit that accused the pharmaceutical company, AbbVie, of failing to warn about the risks of its product. Several lawsuits against AbbVie and Abbott Laboratories, another manufacturer of testosterone replacement therapy, were centralized by the federal judiciary in what is referred to as “Multi-District Litigation” (MDL). The MDL grew to involve 6,100 lawsuits against Eli Lilly, the manufacturer of Axiron, AbbVie, and Abbott Laboratories.
The Oregon resident’s case went to trial first and was awarded $150 million in punitive damages. Unfortunately, no compensatory damages were awarded. In federal court, punitive damages cannot be awarded without compensatory damages, so it was thought the award would not likely survive an appeal.
Among the most important legal issues involved in Axiron lawsuits would be the following:
- Negligence Liability: One of the main problems is that the warning labels for Axiron were defective in that they lacked information regarding the risks of heart failure, heart attacks, and strokes, especially in older men and those who have taken the drug over the years. These warning label defects can be the basis for a case based on negligence. The victim would have to prove fault on the part of the drug manufacturer, supplier, or the doctor who prescribed the drug;
- Medical Malpractice: Basically, a person who Axiron has injured must establish that the doctor who prescribed Axiron for them knew or should have known of the dangerous propensities of the drug or knew or should have known it was not the appropriate treatment for the person, and failed to act reasonably under the circumstances. They may have been negligent in two respects, for prescribing the drug and for failing to warn of its known dangers;
- Substantial Factor: One of the most difficult tasks in a prescription drug case is proving that the product caused the victim’s injury. To prove causation, the victim must prove that the drug was a substantial factor in causing the injury or disease they suffered.
Again, a major concern is when a patient begins using Axiron doses without being properly informed or warned of possible side effects. A doctor, nurse, drug manufacturer, or other parties may be liable for the injuries that result. For this reason, Axiron injury lawsuits may be complex and require the help of a lawyer.
Do I Need a Lawyer for Help with Axiron Injury Claims?
Axiron lawsuits can involve several different legal issues and medical issues as well. You need to consult a class action lawyer to help file a testosterone booster product claim. Your attorney can help inform you of the possible courses of action and can represent you in a lawsuit to recover damages for your losses. An experienced lawyer can also keep you informed regarding any new changes or updates to the status of Axiron and applicable law.
