In response to a number of queries from stakeholders, RB confirms in a press release that Reckitt Benckiser Pharmaceuticals Inc. confirms that it notified the U.S. Food and Drug Administration (FDA) on September 18, 2012 that the company is voluntarily discontinuing the supply of Suboxone Tablets in the US (buprenorphine and naloxone sublingual tablets [CIII]) due to increasing concerns with pediatric exposure. The company received an analysis of data from U.S. Poison Control Centers on September 15, 2012 that found consistently and significantly higher rates of accidental unsupervised pediatric exposure with Suboxone Tablets (buprenorphine and naloxone sublingual tablets [CIII]) than seen with Suboxone Film (buprenorphine and naloxone sublingual film [CIII]). The rates for Suboxone Tablets were 7.8 – 8.5 times greater depending on the study period.
While the data do not isolate the root cause of these findings, the unique child resistant, unit-dose packaging of the next generation Suboxone Film is believed to be one of the key contributing factors to the decrease in exposure rates compared to Suboxone Tablets that are distributed in a multi-dose bottle containing 30 tablets, since the active ingredients of both products are the same. Other factors may include Reckitt Benckiser Pharmaceuticals’ community and healthcare professional educational initiatives in addition to the company’s Risk Evaluation and Mitigation Strategy program.
Reckitt Benckiser Pharmaceuticals is working closely with the FDA and the broader healthcare community to ensure patients currently taking Suboxone Tablets have sufficient time and notification to appropriately transition to the same effective active ingredient with Suboxone Film to minimize any risk to the continuity of their treatment. The press release stated that they anticipate that distribution of Suboxone Tablets will be discontinued within the next six months, possibly sooner depending on discussions with the FDA.
The pediatric exposure safety issue is not related to the active ingredients found in both Suboxone Tablets and Suboxone Film. The company encourages patients currently taking Suboxone Tablets to continue with their treatment and consult their physician about how to transition to Suboxone Film. Suboxone Film is covered by the majority of insurance plans, Medicare and Medicaid. Additionally, patients can access a savings program at Suboxone.com or from their physician to offset out-of-pocket costs associated with their medication. Since the U.S. launch of Suboxone in 2003, it is estimated that over three million Americans with opioid dependence have been treated with the safe and effective active ingredients in Suboxone Tablets and Suboxone Film, buprenorphine and naloxone.