02/03/2017

Photo (c) AdobeStock More than 10,000 adverse event reports complaining about the side effects of a commonly used drug called Lupron have been filed with the Food and Drug Administration, according to a recent report by Kaiser Health News, yet both the drug-maker and the FDA have so far failed to warn pediatric patients or their parents about the drug’s side effects.

Lupron, currently manufactured by AbbVie, is an injection designed to reduce testosterone in men or estrogen in women.

For men, the drug is approved for the treatment of prostate cancer. Though patients complain about experiencing side effects like impotence while on Lupron, research suggests that the drug diminishes the risk of cancer returning and prolongs cancer patients' lives. But what benefits the drug has for women and children, if any, is a matter for debate.

Off-label use in children comes with serious dangers, adults say

For young girls, Lupron was approved to delay the onset of puberty. Off-label, doctors commonly use it to help pediatric patients grow taller. But interviews with women who received the injections for at least a decade as children, conducted by Kaiser Health News, suggest that the drug causes lifelong health problems.

The problems documented in the Kaiser report include extremely brittle bones, anxiety, and seizures. In fact, the FDA told Kaiser Health News that it is currently reviewing the effect that Lupron has on pediatric patients and their nervous systems. But the agency has not yet placed a warning on the drug’s pediatric version describing the potential risk of seizures, bone loss, or mood disorders.

In another statement to Kaiser Health News, AbbVie says that the drug was approved to treat Central Precocious Puberty, defined as developing sexual characteristics before the age of 8 in girls and 9 in boys, but “Uses beyond those contained in the approved label are considered unapproved uses,” the report quotes an AbbVie spokesman as saying.

A danger to adult patients too?

It’s not just women who received the drug as children who say they suffer side effects. Women who were prescribed the drug as adults to treat endometriosis also complain of bone loss, hair loss, weight gain, and memory loss, according to advocacy group the National Women’s Health Network.

“The women contacting the Network relate very similar experiences: they were healthy but -- after using Lupron -- they report having lost their health, their jobs, and more,” the advocacy group wrote in a newsletter that dates back to 2008. “While only a small percentage of women seem to have such a severe reaction, there is no way to predict who will experience these frightening and debilitating side-effects.”

Off-label, Lupron is commonly injected in adult women who have agreed to donate their eggs for profit, a procedure that researchers have for years warned is not well understood or studied. In fact, there is no research studying the long-term health effects of egg donation on egg donors, as the Washington Post reported last year in a story about an egg donor who developed breast cancer in her early thirties.

Lupron use, in particular for egg donation, has been linked to "subsequent infertility, a possible link to certain cancers, and more prevalent short-term problems with Ovarian Hyperstimulation Syndrome (OHSS) than previously reported in the literature," the National Women's Health Network wrote last year. "Given the strong anecdotal evidence of such problems, more well-done studies are critically needed."

AbbVie does tell its adult patients about the risks that come with Lupron. Taking Lupron for endometriosis can cause “thinning of the bones, which may not be completely reversible,” AbbVie writes, and for men with prostate cancer, AbbVie says that “LUPRON DEPOT may cause impotence.”

This is not the first time that Lupron has come under serious scrutiny. Back in 2001, Abbott Laboratories and Takeda Chemicals agreed to pay a whopping $875 million settlement to the Department of Justice over their aggressive marketing of Lupron. According to the DOJ, the drug-makers gave doctors illegal kickbacks in exchange for prescribing Lupron to patients. They also helped doctors bill Medicare or Medicaid hundreds of dollars for each dose.

Despite the controversies, AbbVie’s Lupron is still commercially a success. The drug-maker reported making $826 million on Lupron sales in 2015. “Total company revenue growth was also driven by $554 million in global VIEKIRA sales in the quarter,” AbbVie wrote in a report last year to investors, “as well as strong operational growth from Duodopa, Creon and Lupron.”