Public Health Officials Petition FDA for Black Box Warnings and Medication Guides Regarding Serious Risks of Combining Opioids With Benzodiazepines

2016FDAPetition

This petition to the FDA was signed by 41 people who are career political bureaucrats and those who live in academia’s  “Ivory Tower”  Is that who should be determining what practicing healthcare professionals should be doing in the “real world ” ?

A petition submitted to Food and Drug Administration (FDA) requests that the agency add a black box warning on all medications in the opioid and benzodiazepine classes to warn prescribers and patients about a reduced margin of safety and increased risk of fatal overdose when these classes of medication are used together. Signed by 41 physicians, including state and local department of health directors, public health officials, and school of medicine faculty, among others, the petition also requests that FDA require medication guides for both classes of medications to specifically warn patients of the potential dangers of combined use of opioids and benzodiazepines. Current warnings “fail to reflect the strong biologic and epidemiological data on risks to patients of respiratory depression and fatal overdose from combining these classes of medications,” according to the petition. A black box warning would emphasize to patients the need to discard old or expired medications that could be combined with new prescriptions for dangerous effects, indicates the petition. The petitioners also state that the warnings would support public education efforts aimed at informing the general public about the epidemic of fatal overdose

Filed under: General Problems