Reckitt Pulls Its Suboxone Tablets From the US Market
The pharma giant says its decision is due to concerns over child safety—not a desire to promote its more profitable Suboxone films.
Reckitt Benckiser—the British company that manufactures Suboxone—is taking its tablet formulation of the drug off the US market, it announced today. Reckitt says it notified the FDA last week of its plans to withdraw the pills, “due to increasing concerns with pediatric exposure.” Its announcement links the decision to a report the company received 10 days ago from the US Poison Control Centers that found Suboxone tablets—which are dispensed in bottles with child-proof caps, like most other prescription pills—were about eight times likelier to fall into kids' hands than the company's Suboxone films, which come in individual sealed envelopes. It’s unclear exactly how many pediatric exposures are involved, as the announcement cites only rates of exposure. Reckitt has yet to respond to The Fix's request for a copy of the report.
Reckitt’s global medical director, Tim Baxter, MD, told The Fix last month that the company knows of just four cases of children dying due to the accidental ingestion of Suboxone tablets. The Substance Abuse and Mental Health Services Administration’s Drug Abuse Warning Network reports that, in 2009 (the most recent year with available data), buprenorphine products in general were involved in 1.3% of ER visits. Suboxone contains buprenorphine, which is used in short-term detox and longer-term medication assisted therapy. Its partial-agonist action makes it much less likely to cause fatal respiratory depression than full agonists—including popular painkillers like oxycodone and hydrocodone—which commonly come in pill form, not individually wrapped doses. Reckitt’s decision to pull the tablets coincides with imminent plans to introduce its new, patented higher-dose films—and comes in the wake of Reckitt losing its patent on the pills. The company notified shareholders last year that it could lose more than 80% of profits from Suboxone tablets if a cheaper generic alternative emerges. But a spokesman denies that this is the reason for the newly-announced decision.