The Food and Drug Administration yesterday warned the health care community about complications that arise when pairing pain medications with intrathecal implanted pumps when the medications are not approved for use with those devices, which deliver medicine into spinal fluid. Clinicians may have chosen these alternatives – such as hydromorphone, bupivacaine, fentanyl and clonidine – to avoid the side effects of approved drugs, or because they may appear to be more effective at relieving pain, the FDA said. However, such substitutions might not meet the additional safety standards required of approved drugs, and as such, can cause dosing errors, pump failure, opioid withdrawal and infection, the agency said.
 
“We urge health care providers, patients and caregivers to be aware of the information the FDA is providing today so they can make informed treatment decisions,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA will continue to monitor the safety of these and other medical devices involved in the treatment of pain, and take action where needed to protect patients.”

Related News Articles

Headline
The National Institutes of Health today selected several universities to partner with communities in Kentucky, Massachusetts, New York and Ohio to study the…
Headline
The Food and Drug Administration today ordered manufacturers to immediately stop selling and distributing surgical mesh products for transvaginal repair of…
Headline
Updated preliminary results from studies to better understand how duodenoscopes are reprocessed in real-world settings continue to show higher than expected…
Headline
The Food and Drug Administration yesterday announced changes to the prescribing information included in outpatient opioid pain medication labels.
Headline
The Agency for Healthcare Research and Quality is accepting comments through April 25 on a draft report on treatment for acute pain.
Headline
The Food and Drug Administration plans to revise its 2016 draft compounding guidance for hospital and health system pharmacies.