Pharmaceutical

Pediatric use of testosterone suppressant Lupon linked to serious adverse events

children smiling for WEB Pediatric use of testosterone suppressant Lupon linked to serious adverse eventsThe testosterone suppressant Lupon used to treat prostate cancer, endometriosis, uterine fibroids and, in girls, premature puberty, is widely used off-label to help children and adolescents grow taller. The drug has been linked to more than 10,000 adverse events. However, AbbVie, the drug’s maker, and the Food and Drug Administration (FDA) have not done enough to warn consumers about these risks, according to a recently released report by Kaiser Health News.

Kaiser’s investigation involved interviews and online forums, and found that women who took the drug as young girls or initiated a daughter’s treatment reported serious side effects later in life. Reports included a 20-year-old diagnosed with very low bone density called osteopenia, a 25-year-old with osteoporosis and cracked spine, a 26-year-old who needed a total hip replacement, and a 25-year-old with chronic pain and degenerative disc disease.

Girls who were given the injection to delay puberty or grow taller reported feelings of depression and anxiety, suicide ideology, and even seizures. The mounting adverse events have caught the attention of the FDA, which told Kaiser that it was conducting a specific review of nervous system and psychiatric events associated with pediatric use of GnRH agonists, the class of drugs that includes Lupon. The agency also said it was reviewing reports of deadly seizures in pediatric patients who were treated with drugs in the class.

Using Lupon to increase growth potential in children is not an FDA-approved use of the medication. Drug companies cannot legally promote drugs for off-label uses but doctors have the discretion to prescribe medications for uses for which they are not approved.

In 2009, an international consortium of pediatricians warned that Lupon and similar drugs were being prescribed too widely for off-label uses even though the safety of these drugs on developing bodies had not been proven.

Even when the drug’s indication was expanded for pediatric uses two decades ago, former FDA medical officer Dr. Alexander wrote a memo saying that it was “regrettable” that the panel approved the medication with only minimal trial data to support its safety and efficacy. The study followed just 22 children for six months.

The adverse events are not limited to pediatric patients. Women who were prescribed Lupon as adults to treat endometriosis also reported bone loss, hair loss, weight gain, and memory loss, the National Women’s Health Network reported.

Despite the risks, Lupon continues to be a cash cow for AbbVie, reportedly bringing in $826 million in sales for 2015.

Source: Stat