A drug increasingly being used in the United States to treat opioid addiction is being taken off the market in tablet form because of the risk it poses to children. Reckitt Benckiser, a British pharmaceutical company, said new data showed that Suboxone pills were significantly more likely to be swallowed accidentally by children than other formulations of the medication.
The company said it would voluntarily stop distribution of Suboxone tablets over the next six months. Reckittt says it made the decision after learning from the U.S. Poison Control Center that “accidental unsupervised pediatric exposure” to Suboxone pills was over eight times more likely than the film version of the drug.
Suboxone film contains the same active ingredients as the tablet, but is designed to dissolve under the tongue. Reckitt believes the film is more child resistant because each dose is individually wrapped – as opposed to the tablets, which come in a standard medication vial containing up to 30 tablets. Although the vials have child-proof tops, recovering addicts may forget to put the tops back on.
“We recognize many patients have relied on Suboxone Tablets to manage opioid dependence over the years and understand there may be concerns about this discontinuation, and we are committed to helping all patients and providers to ensure that managing this serious, chronic disease is not interrupted,” said Richard Simkin, President of Reckitt Benckiser.
Suboxone is currently the only oral drug available on the U.S. market to treat opioid addiction. It contains the opioid buprenorphine, which is combined with naloxone to prevent abuse. The opioid effects of Suboxone are limited and the drug is used to wean addicts from more powerful narcotics such as Vicodin, OxyContin, oxycodone, and hydrocodone. Naloxone is added to Suboxone to block opioid receptors in the brain and central nervous system.
Suboxone sales reached $1.3 billion in the U.S. in 2011 and are growing by about 10% annually.
Cynics were quick to note there may be other factors involved in the decision to take Suboxone tablets off the market. Reckitt’s tablet formulation went off patent in 2009 and the company faces increasing competition from competitors. The film version is still patent protected and accounts for a growing share of Suboxone sales. Reckitt warned shareholders in its annual report that “up to 80% of the revenue and profit from the suboxone tablet business in the U.S. might be lost” to generic competition.
Opioid abuse is a growing problem in the U.S. and a new report this week estimated that 1.4 million Americans are addicted to painkillers. Since Suboxone was introduced in the U.S. in 2003, over three million Americans with opioid dependence have been treated with Suboxone.
In a recent report published in the Journal of Addictive Diseases, the Center for Substance Abuse Research at the University of Maryland warned “there may be an epidemic of buprenorphine misuse emerging across the U.S.” because Suboxone was being so widely prescribed to treat addicts. Researchers said addicts were smuggling buprenorphine into jails and the drug’s street value was growing because it doesn’t show up in drug tests.