SLOUGH (dpa-AFX) - Reckitt Benckiser Group Plc (RB.L, RBGPF.PK) said Reckitt Benckiser Pharmaceuticals Inc. confirmed that it notified the U.S. Food and Drug Administration, or FDA, on September 18, 2012 that the company is voluntarily discontinuing the supply of Suboxone Tablets (buprenorphine and naloxone sublingual tablets [CIII]) due to increasing concerns with pediatric exposure.
The company obtained 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 than seen with Suboxone Film. The rates for Suboxone Tablets were 7.8 - 8.5 times greater depending on the study period.
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 company expects that distribution of Suboxone Tablets will be discontinued within the next six months, possibly sooner depending on talks with the FDA.
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© 2012 AFX News
