Eli Lilly & Co. is discontinuing two of its Axiron testosterone replacement therapy solutions and its authorized generic testosterone solution because there are multiple manufacturers that are currently selling the products, according to MPR. The discontinued products include Axiron 30mg /1.5mL with the NDC 0002-1975-90, Axiron 30mg/1.5mL with the NDC 0002-1975-61, and generic testosterone 30mg/1.5mL with the NDC 66993-963-89.
Axiron solution is an androgen used to treat adult men with congenital or acquired primary hypogonadiasm or hypogonadotropic hypogonadism. It is supplied as a 90mL pump containing 60 metered pump or twist actuations with an applicator.
Eli Lilly claims that the removal of the Axiron solutions is not related to safety or efficacy issues, however the product is one of several testosterone treatments named in a multidistrict litigation involving 6,000 cases consolidated in the U.S. District Court for the Northern District of Illinois over testosterone side effects. The lawsuits claim that testosterone manufacturers aggressively promoted their products directly to consumers as treatments for symptoms such as low libido, weight gain and mood swings, for a made-up condition they called Low T. But the drug companies never warned that testosterone therapy was linked to cardiovascular risks including heart attacks, strokes and blood clots, the complaints allege.
In July, U.S. District Judge Matthew K. Kennelly selected two cases involving Eli Lilly’s Axiron to serve as bellwethers – the case of Tracy Garner and the case of John Debroka Jr. Garner claims to have had a heart attack after starting treatment with Axiron. Debroka alleges he developed deep vein thrombosis – a blood clot deep in the veins – after using Lilly’s Axiron.