A suit filed in federal court in Newark, New Jersey claims that Eli Lilly failed to adequately warn of the risk of heart attacks and stroke with its testosterone replacement drug Axiron
Lilly markets Axiron to men by describing “symptoms” of “Low T,” such as decreased sexual desire, erectile dysfunction, fatigue and loss of energy, depressed mood, decreased strength and osteoporosis. But the lawsuit claims Low T is a “non-existent and unrecognized medical condition,” according to New Jersey Law Journal. The symptoms are often merely the result of increasing age or weight gain, according to court papers.
The plaintiff began taking Axiron at age 54 in September 2012, and he suffered a heart attack in October 2012. The man’s doctor would not have prescribed Axiron, the suit says, if he had been warned of the increased risks of heart problems caused by the drug. The Food and Drug Administration (FDA) approved Axiron for treatment of an endocrine disorder called hypogonadism, but a study showed that only 6 percent of men for whom the Axiron was prescribed have the condition, according to New Jersey Law Journal.
Lilly mounted an aggressive “disease awareness campaign” to alert men that they might be suffering from “Low T” but the FDA has not approved any drug for the treatment of such a condition, New Jersey Law Journal reports. Furthermore, “low testosterone is not a disease recognized by the medical community.” Lilly promoted Axiron for off-label uses, the lawsuit alleges, though a manufacturer may not promote a drug except for approved uses. The lawsuit alleges Lilly “marketed and sold testosterone as a lifestyle drug meant to make men feel younger and increase libido.”
In January, the FDA announced it is investigating the risk of stroke, heart attack and death for men who use testosterone products. In June, the U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of all federal litigation over testosterone replacement therapies in the Northern District of Illinois. Lilly is a defendant in the multidistrict litigation over testosterone, along with AbbVie, Abbott Laboratories, Actavis and Auxilium Pharmaceuticals, Endo Pharmaceuticals and Pfizer, New Jersey Law Journal reports.