Lupron is used for a variety of purposes. It is prescribed to children to treat early-onset puberty, to men who exhibit symptoms of prostate cancer in men, and to women with endometriosis, a condition in which the uterine lining grows outside the uterus. Lupron is also used widely off-label as a "down regulator" for women going through IVF treatment. Patients take Lupron in a single day dose in the form of daily shots. Lupron Depot is given in an extended release injection that lasts for 30 days.
At least one expert believes Lupron should be pulled from the market. Dr. John L. Gueriguian, former medical officer with the US Food and Drug Administration (FDA), stated in a report for a pharmaceutical liability lawsuit on 3/19/08 that Lupron should not be used.
"After years of use of [Lupron] in a great number of patients, the evidence is clear that TAP [Takeda Abbott Pharmaceuticals] didn't study [Lupron] adequately before marketing," Gueriguian states in his report. "After its introduction into the marketplace, TAP did not perform enough long-term studies to detect potential long-term and irreversible side effects of [Lupron], which has been shown, through independent observations and studies, to be able to cause irreversible side effects and permanent severely disabling health problems. Lupron temporarily stops menstruation, but does not eradicate endometriosis for long-term. Lupron should only be limited to six injections for the initial treatment, and a retreatment should not exceed six injections. Lupron cannot be given more than twelve injections per lifetime."
He goes on to say that endometriosis can grow back after Lupron treatment ends. What's more, Lupron was used to treat endometriosis in females under the age of 18, despite the fact that the drug had only been tested on women over the age of 18 with endometriosis.
Dr. Gueriguian alleges that that TAP intentionally suppressed knowledge about the risks associated with Lupron, including bone density loss (leading to permanent disability in some cases), generalized pain, headaches, fluid retention, depression and immune and nervous system problems, including spinal fracture, convulsions and paralysis.
Drugs whose risks outweigh their benefits should be pulled from the market, the report concludes.
Lupron, manufactured originally by TAP and now by Abbott, resulted from a joint venture between Takeda Pharmaceuticals and Abbott. The companies subsequently split in 2008, leaving Abbott with the rights to Lupron.
According to ABC News in Las Vegas (ktnv.com, 10/30/09), TAP pleaded guilty in 2001 to criminal charges that it violated the Federal Prescription Drug Marketing Act. The pharmaceutical company agreed to pay $875 million to settle claims that it paid kickbacks to doctors to promote Lupron. Dr. Andrew Friedman admitted that he falsified and fabricated 80 percent of the data in leuprolide acetate (Lupron) research reports.
The FDA has received more than 12,000 reports of adverse events linked to Lupron, including more than 1,100 deaths.