Food and Drug Administration Requiring Changes to Drug Labels
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Food and Drug Administration Requiring Changes to Drug Labels

The agency hopes to inform healthcare providers and patients of risks of combining drugs

September 1, 2016

After carefully reviewing the latest scientific evidence, the Food and Drug Administration (FDA) is now requiring class-wide changes to drug labels, including patient information.

The reason for the change is a hope that doing so will better inform healthcare providers and patients alike about the serious risks of combining certain opioid medications with a class of central nervous system depressants known as benzodiazepines.

The FDA now requires boxed warnings—its strongest warning—as well as Medication Guides focused on the patient for any prescription opioid analgesic, any cough product containing an opioid, and any benzodiazepine, affecting a total of almost 400 products. The warnings and guides will include information about the serious risks of using these medications concurrently, including extreme sleepiness, respiratory depression, coma, and death.

"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."

Because of how important it is to reach healthcare professionals as well as the public with this information, the FDA is also issuing a Drug Safety Communication. By requiring Medication Guides for patients and issuing the Communication, the agency is also providing information for any person taking, or who knows someone who is taking, either of these kinds of medicines and encourages them to improve their understanding of the risks of combining them. The information also encourages healthcare providers, when medically necessary, to take care to prescribe the medications only as directed and not to increase either the dose or the frequency of the dose for either drug.

An opioid analgesic is a powerful medication that reduces pain. Brand and generic prescription oxycodone, hydrocodone, and morphine fall into this category, along with other drugs. Certain medications of this type are also approved to treat cough as well as pain. Benzodiazepines, on the other hand, are usually prescribed to treat neurological and/or psychological conditions, such as anxiety, insomnia, and seizure disorders.

The past two decades have seen significant increases in the misuse and abuse of opioid analgesics in the U.S. This is a public health concern because of the risk of coma and fatal respiratory depression that is associated with overdosing on these medications.

Both benzodiazepines and opioid analgesics have the effect of depressing the central nervous system, but each has unique pharmacology, safety risks, and labeling information. For this reason, opioid analgesics, benzodiazepines, and prescription opioid cough products are now required to be labeled slightly differently. Furthermore, because patients who are undergoing medication-assisted therapy (MAT) treatment for opioid addition and dependence have unique medical needs and benefit/risk considerations, the FDA will continue examining all available evidence on using benzodiazepines and opioids as part of MAT.

Data reviewed by the agency indicated that doctors have been prescribing the medications together more and more often, which has been associated with negative outcomes to patients. From 2004 through 2011, the number of visits to emergency rooms for the non-medical use of both medications rose significantly, and the number of deaths resulting from overdoses involving both almost tripled. Between 2002 and 2014, the number of patients prescribed both types rose by 41 percent, which means that there was an increase of more than two and a half million in the number of opioid analgesic patients who also received benzodiazepines.

"Working with the health care community and federal and state partners to help reduce opioid misuse and abuse and improve appropriate opioid prescribing, while ensuring that patients in pain continue to have appropriate access to opioid analgesics, is a top priority for the FDA and part of [the Department of Health and Human Services's] targeted approach focused on prevention, treatment, and intervention," said the FDA.

"The agency is committed to continuing to monitor these products and take further actions as needed."