Several Testosterone Therapy Supplements Filed
Testostorone therapy has become extremely popular. AndroGel and other low testosterone (“Low T”) treatments are prescribed to treat hypogonadism, a condition which causes low testosterone levels. The FDA’s approval of AndroGel is limited to treatment for low testosterone levels related to hypogonadism, not problems related to age.
Although it has been marketed and prescribed for hypogonadism, AndroGel has also been aggressively marketed and prescribed to men experiencing the common signs and symptoms of aging.
Over-prescribing AndroGel may have benefited Abbott’s bottom line, but it comes at cost. According to a recent study, men who take testosterone drugs are at an increased risk of developing a heart attack or stroke. This risk is exacerbated by the claim that as many as 40% of men taking low t therapy do not have low testosterone and do not need Low T treatment.
The Strom Law Firm is now investigating cases on behalf of individuals who have taken testosterone replacement therapy drugs including:
- Androgel
- Testim and
- Axiron.
If you or a loved one used AndroGel, or another other testosterone therapy, and suffered any of the following:
- Heart attack
- Stroke
- Transient ischemic attacks
- Pulmonary embolism
- Coronary artery disease
- Death
you should contact us for a free, confidential consultation to discuss your legal rights, and whether you may have a claim for compensation against Androgel or another Low T therapy provider.
False and Deceptive Advertising of Low Testosterone Products
Androgel and other low testosterone “Low T” treatments, including gels, patches, pellets and injections, have been linked with an increased risk of cardiac problems in middle aged men with a history of heart disease. Despite these risks, Androgel and other low testosterone therapies have been aggressively marketed to older men or men with low levels of testosterone as a cure-all to fix their sex lives, low energy, and gain muscle mass.
Despite their marketing claims, several medical studies, including one published in the Journal of the American Medical Association (JAMA) and one conducted by Veterans Affairs, show that testosterone therapy may offer little or no actual benefit, and actually increases the risk of blood clots, strokes, and heart attacks in users. Many consumer groups are pushing for a black box warning label on testosterone therapy drugs disclosing the risks associated with Low T treatment. A number of AndroGel lawsuits have now been filed by men asserting that they were not warned of the risks associated with Low T therapy.
FDA Investigation of AndroGel
The FDA approved AndroGel specifically for low testosterone levels related to hypogonadism, not related to age. The Food and Drug Administration (FDA) issued a statement earlier this year announcing that the FDA will investigate the reported increased risk of heart attack, stroke, and even death for men using testosterone therapy supplements.
Although the FDA approved some testosterone therapy for patients with hypogonadism (a condition that affects the testes, pituitary gland, hypothalamus), testosterone therapy has been marketed to older men whose “low T” is related to age, not to a medical condition. Patients prescribed testosterone therapy by their doctor may not have a medical need for the drug, and can therefore put themselves at risk of serious side effects.
It is important to note that the FDA has never approved testosterone therapy as a treatment for low libido or low energy. “None of the testosterone products have indications for weight loss, increasing energy or improving mood,” said Andrea Fischer, a spokeswoman for the FDA, in comments published in the New York Times.
FDA-approved testosterone formulations include the topical gel (like Androgel®), transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.
According to a Veterans Affairs study, which tracked 8,700 men nationally, men who underwent testosterone therapy were 30% more likely to suffer a heart attack or stroke, or die from a cardiac episode, during a three-year period than men with low testosterone who did not take supplements. Most of the men involved in the study had other problems such as high blood pressure, unhealthy cholesterol levels, and diabetes; all of the participants were in their 60’s or older.
Prior to taking part in the testosterone therapy study, all the participants underwent heart imaging and many had risk factors for heart attacks or strokes. However, nearly 26% of the participants using testosterone therapy had one of the potential bad outcomes during the course of the three-year study, compared to 20% of nonusers.
While most of the studies have not conclusively shown a direct link between testosterone therapy and heart attack or stroke risk, researchers warn that testosterone therapy seems to significantly increase risk when other risk factors exist.
Call Today for Your Free Consultation
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices. We represent individuals who have been killed or injured by dangerous or defective drugs including AndroGel and other testosterone treatments. If you or a family member suffered a heart attack, stroke, pulmonary embolism or other serious side effect while undergoing testosterone therapy, our attorneys may be able to assist you. Contact us today for a free consultation to discuss the facts of your case. 803.252.4800
