FDA adds 'Boxed Warnings' to certain opioids, benzodiazepines

The FDA recommended Aug. 31 that healthcare providers limit prescribing pain-killing or cough-suppressing opioids and benzodiazepines together, which could be a dangerous combination.

The agency said the combination is only suitable for “patients for whom alternative treatment options are inadequate” because both types of drugs are central nervous system depressors and can cause side effects such as difficult breathing or even death.

The new recommendations will also require drug makers to include a warning about the combination of the two drugs on the prescriptions-strength iterations of the drugs. "Boxed Warnings" are the strongest type of warnings, according to the FDA.

In addition to limited prescribing of the drugs, the statement said, physicians should warn their patients about the potential dangers of taking the two types of medication together, or in combination with any other kind of central nervous system depressing drug or alcohol.

The FDA also warned patients and caregivers to be alert to such side effects and to contact a healthcare provider immediately if symptoms of dizziness, lightheadedness, difficulty breathing or drowsiness appear while taking these two drugs together.

The FDA’s statement said more information is forthcoming on research related to labeling changes for other types of central nervous system depressor drugs and drugs that are used to treat opioid dependence.