A recent FDA letter reports that the agency may be reconsidering its ‘Black Box’ warning label policy. Under the current policy, only extended-release opiates require the special label, but the FDA said it may consider the same warning for immediate-release opiates.
The letter responds to recent concerns from U.S. Congressional members. Bipartisan leaders of the House Energy & Commerce Committee have expressed concerns about the 2013 policy, which exempts immediate-release opiates from the black box warning label. The committee leaders also expressed concern over the effectiveness of risk evaluation and mitigation strategies (REMS) for extended-release opiates.
In response to requests for information, the FDA pointed to data from a petition filed by Purdue Pharma in 2014, which illustrated similar risks for abuse with both immediate-release and extended-release opiates. The FDA also referred to a 2014 REMS assessment report that showed a decrease in prescriptions—as well as in abuse, misuse and deaths—for both versions of the potent painkillers. However, the FDA noted that REMS may not have been the sole reason for this positive trend.