Doctors call for use of safer drug formulation, drug maker responds

Candy-look-alike prescriptions for adults a danger for toddlers at home

By Sandra Gray

UMass Medical School Communications

October 05, 2012
  Broadhurst-James    Bateman-Scot
  James Broadhurst, MD   Scot Bateman, MD

In even the best child-proofed homes, toddlers may find ways to put things in their mouths that don’t belong there, including drugs that are safe for adults but poisonous to children. One drug seen with alarming regularity in children brought to the hospital for accidental ingestion is Suboxone (generically known as buprenorphine/naloxone), which helps protect adults from withdrawal and promotes recovery from addiction to heroin and other opiates, including prescription painkillers. A more convenient alternative to methadone treatment, which entails travelling to a medical facility, Suboxone can be taken by patients at home, and is often prescribed to adults living in homes that also house toddlers.


The form of Suboxone most often covered by insurers, the pinkish-orange, lemon-lime flavored sublingual pill is formulated to dissolve in the mouth so that it reaches the bloodstream as quickly as possible. It looks and tastes like candy, making it attractive to very young children—and its fast-dissolving action makes it especially toxic to them.

So attractive and so toxic, in fact, that the Pediatric Intensive Care Unit (PICU) at UMass Memorial Medical Center has been admitting approximately one child every month suffering from an overdose after accidentally putting the pill in his or her mouth and, without even needing to swallow it, getting the toxic effects of the sublingual Suboxone.

In what comes as great news to physicians, including those at UMass Medical School and UMass Memorial who have witnessed the problem firsthand and have advocated for insurers to cover a more child-resistant version of the drug, European Suboxone manufacturer Reckitt Benckiser Pharmaceuticals announced on Sept. 26 that it will withdraw the sublingual pill formulation of the drug from the market in the United States, citing increasing concerns with pediatric exposure. The manufacturer had developed a far safer film formulation of the medicine, which was approved by the United States Food and Drug Administration in August 2010, but insurers were slow to add the film version to their formularies.

“This issue became important to me because it was ongoing, potentially life-threatening—and in every single case that I admitted a child to the PICU for this problem, it was preventable,” said Scot Bateman, MD, clinical associate professor of pediatrics and director of the UMass Memorial PICU. “Thankfully we have an antidote and haven’t seen any deaths, but it is traumatic for the families and frustrating for us.” Dr. Bateman also lauded PICU social worker Pat Vanasse, MSW, who works closely with affected families after a child is stabilized and discharged from the hospital, “for keeping the issue at the forefront at UMass Memorial.”

In “Toddlers requiring pediatric intensive care unit admission following at-home exposure to buprenorphine/naloxone,” published in Pediatric Critical Care Medicine in March 2011, Bateman and School of Medicine graduate Ernest Pedapati, MD, documented the troubling statistic of Suboxone accounting for 33 percent of accidental ingestions by toddlers that resulted in PICU admissions at just one hospital, suggesting a more widespread problem. The paper also proposed a solution that aligned with the drug maker’s recent decision, calling for insurers to cover the far more child-resistant, individually wrapped film for patients who live in homes with young children.

Other Massachusetts physicians have weighed in as well. A resolution advocating to health insurers that “the presence of a child in the household be cause to cover a child-proof or tamper-proof version of a prescribed drug where available” was proposed by James Broadhurst, MD, assistant professor of family medicine & community health, and adopted by the Massachusetts Medical Society last spring. “The power of organized medicine can be very useful when we have an issue we want to highlight,” Dr. Broadhurst said prior to the Reckitt Benckiser announcement.

With the manufacturer’s voluntary withdrawal of the sublingual pill form from the market, insurers may now have no choice. “The film formulation that is individually wrapped is as effective as the sublingual pill and is more child-safe,” Bateman noted. “We are so glad to see pediatric safety at the forefront, and hope that, in some small way, we helped raise awareness of this issue.”

Related links:
How Many Licks Does it Take to get into the Pediatric Intensive Care Unit? The Hazards of Accidental Ingestion of buprenorphine/naloxone (Suboxone) in Children
Massachusetts Medical Society House of Delegates Resolution 211: Child Safety, MassHealth and Suboxone