On August 31, 2016 the Food and Drug Administration (FDA) issued a new directive to include the “black box” label on approximately 400 opioid and benzodiazepine products. Opioids are powerful pain reducing medications including prescription oxycodone, hydrocodone and morphine. Benzodiazepines are typically prescribed to treat conditions such as anxiety, insomnia and seizures. Examples of these products include alprazolam, clonazepam and lorazepam. Both types of drugs depress the central nervous system.
In February, 2016, health officials from more than thirty states, cities, medical schools, and health organizations filed a petition with the FDA asking the agency to strengthen the existing labeling for these products. When it received the petition, the FDA had already been engaged in a scientific review of the potential effects of using the two drugs together, and the petition encouraged a deeper look into the issue. The FDA’s review showed that physicians have been increasingly prescribing them together, rising by 41 percent between 2002 and 2014, that emergency room visits resulting from non-medical use of the two drugs had also increased significantly, and that overdose deaths from taking the prescribed dose or a greater dose involving both opioids and benzodiazepines nearly tripled between 2004 and 2011.
The FDA Commissioner, Dr. Robert Califf, called this “nothing short of a public health crisis.” Based on the evidence that surfaced as a result of the review, the FDA determined that the black box warning was necessary to inform and protect consumers and physicians against the risks of using the drugs together Although some opioid products did contain warnings against mixing with benzodiazepines, the FDA felt that a nationalized directive to use the black box warning was warranted given the results of the scientific review and that all products in either class of drugs needed to include such warnings. The black box is the FDA’s strongest form of warning. As it pertains to these drugs, the black box warns against mixing opioids and benzodiazepines.
In addition to the black box warnings, the FDA is requiring patient-focused Medication Guides for these drugs with information about the serious risks associated with using them at the same time, including extreme drowsiness, respiratory depression, coma, and death. These actions were taken as part of the agency’s Opioids Action Plan aimed at reversing the prescription opioid abuse epidemic while providing patients with access to effective and appropriate pain management.
In announcing the new requirements Dr. Califf called on health care professionals to carefully and thoroughly evaluate, on a patient-by patient basis, whether the benefits of prescribing opioids and benzodiazepines together outweigh the risks. The FDA also urges patients and care givers to consult with health care providers about the combined use of these medications. Hopefully these steps will prove effective in balancing the benefits with the risks associated with these important but potentially dangerous pharmaceutical products.