FDA warns doctors to limit prescribing of opioids, benzodiazepines together

In an effort to prevent overdoses and deaths, the U.S. Food and Drug Administration (FDA) announced on Wednesday tougher warning labels on opioid pain medications and benzodiazepines.

The FDA warned doctors and other clinicians in a safety announcement not to prescribe both drugs to patients simultaneously unless there are no adequate alternative treatments options. The agency said the growing combined use of opioids with benzodiazepines--used to treat anxiety, insomnia and seizures--or other drugs that depress the central nervous system (CNS) has resulted in serious, even fatal, side effects like slowed or difficult breathing.

The FDA has added so-called black box warnings, its strongest warning, to the drug labeling of prescription opioid pain and cough medicines, as well as benzodiazepines. All told, boxed warnings will be required for 389 products, according to a Medscape report.

Conference

2019 Drug Pricing and Reimbursement Stakeholder Summit

Given federal and state pricing requirements arising, press releases from industry leading pharma companies, and the new Drug Transparency Act, it is important to stay ahead of news headlines and anticipated requirements in order to hit company profit targets, maintain value to patients and promote strong, multi-beneficial relationships with manufacturers, providers, payers, and all other stakeholders within the pricing landscape. This conference will provide a platform to encourage a dialogue among such stakeholders in the pricing and reimbursement space so that they can receive a current state of the union regarding regulatory changes while providing actionable insights in anticipation of the future.

Warnings about the risk of prescribing opioids and benzodiazepines together are not new. In response to the country’s opioid addiction crisis, the FDA in March beefed up warning labels for a range of prescription painkillers. The latest change places those black box warnings on even more medications.

"When a boxed warning goes out, it alerts all kinds of people who might have missed the message," FDA Commissioner Robert Califf, M.D., said in a news conference, according to Medscape.

The FDA said if doctors have no choice but to prescribe opioids and benzodiazepines together, they should limit the dose and duration of each drug to the minimum needed to treat the patient. Doctors should warn patients and caregivers about the risk for slowed or difficult breathing. They should also avoid prescribing opioid cough medicines for patients taking benzodiazepines or other CNS depressants, which includes alcohol, according to the announcement. 

Suggested Articles

We need our federal programs and policies to reflect the goal of improving the health of both women and men.

Two lawsuits were filed suing the Trump administration to overturn a new rule that would allow healthcare workers to deny care over religious or conscience…

JLABS executive Kate Merton talks about the JLABS model and Johnson & Johnson’s interest in digital health.