The FDA is requiring a black box warning, which is the strongest warning the agency can issue, regarding the combined use of benzodiazepines and opioid medications, indicating that taking the drugs together can cause severe health risks, including death.
In a safety alert issued August 31, the drug regulatory agency announced that labeling and patient information warnings will be updated for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines, more commonly known as benzos.
Combining powerful pain medications, like OxyContin or Vicodin, with central nervous system (CNS) depressant drugs, like Klonopin or Ativan, may cause extreme sleepiness, respiratory depression, coma or death, according to the warnings.
The label changes will impact nearly 400 products containing opioid analgesics or benzodiazepines, which will feature a prominently placed boxed warning, which is the most severe warning the FDA can require drug makers to place on their products. In addition, information will be placed in patient-focused medication guides, outlining risks associated with combining opioids and benzos.
Health officials indicate that the warnings were added after many patients reported experiencing severe side effects, including overdoses. The FDA reviewed data from 2004 to 2011, which indicated doctors are increasingly prescribing the drugs together. Taking the two drugs together can cause fatal respiratory depression.
The rate of emergency room visits involving use of both drugs increased significantly during that time. Overdose deaths involving both drugs tripled from 2004 to 2011. A study published earlier this year concluded opioid abuse and overdoses have begun to strain the nations intensive care units, doubling in-hospital deaths related to opioids.
The number of patients prescribed both drugs increased by 41 percent from 2002 to 2014. The increase indicated more than 2.5 million patients received both narcotic painkillers, like Vicodin, and benzodiazepines, like Valium, together. Another report indicated use of high-potency narcotic painkillers, like Oxycodone has significantly increased.
Stronger Warnings for Opioids and Benzodiazepines
The changes are part of the FDA’s Opioids Action Plan which focuses on interventions to curb prescription opioid abuse epidemic which has only worsened in recent years.
Data from a CDC report indicated drug overdose deaths have reached an all-time high in the US and overdose deaths involving narcotic painkillers, like OxyContin increased 137 percent since 2000.
The FDA also called for pamphlets to be distributed to patients to help them better understand the medications they are taking, the possible side effects and the risks.
Benzodiazepines are prescribed to treat neurological or psychological conditions, such as anxiety, insomnia and seizure disorders. Benzodiazepines are also a central nervous system depressant and can cause patients to stop breathing and die.
Every day in the US, 44 people die from prescription opioid overdoses. About one in three opioid overdose deaths also involves benzodiazepines. Overall, opioid dependence insurance claims have skyrocketed by more than 3,000 percent in recent years.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf, M.D. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks.”