FDA Roundup: Powdered Gloves, Opioid Warnings, Anthrax

Powdered Medical Glove Ban

The US Food and Drug Administration (FDA) has proposed a ban on powdered surgeon’s gloves, powdered examination gloves, and absorbable powder for lubricating a surgeon’s glove.

The FDA says that the powder added to the gloves can cause health problems when individuals are exposed to it, including severe airway inflammation, wound inflammation, and post-surgical adhesions.

The proposal is a result of a review of scientific literature and feedback from a Federal Register Notice
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If the ban is finalized, the products will be removed from the marketplace completely. However, this won’t cause a glove shortage because there are many non-powered glove options currently available.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

Opioid Warning Labels

The FDA announced new requirements for opioid labels to warn about risks and harmful interactions.

The labels of immediate-release opioid pain medications are now required to include warnings about the serious risks of misuse, abuse, addiction, overdose, and death, as well as the risks of chronic opioid use during pregnancy.

The labels of all opioid medications (including immediate-release and extended-release/long-acting opioids) are required to include safety information about potential drug interactions that may cause harm to the central nervous system, endocrine system, and more.

These changes come as a result of the FDA’s recent plan to reassess its approach to opioid medications in order to help reverse the epidemic. It also aims to inform patients about the importance of balancing the risks of taking opioids and managing pain.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, MD, FDA commissioner.

Anthim to Treat Inhalational Anthrax

The FDA approved Anthim (obiltoxaximab) injection, in combination with appropriate antibacterial drugs, as a treatment for inhalational anthrax. Anthim can also be used as a prevention tool when alternative medications are unavailable or inappropriate.

To understand the efficacy and safety of the injection, researchers conducted animal studies in which half of the infected group was given Anthim and half was given placebo.

Researchers found that animals treated with Anthim were more likely to live than those treated with placebo, and more animals survived when Anthim was combined with antibacterial drugs.

In human trials, only mild side effects—including headache, itching, and cough—were reported.

“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

—Amanda Balbi

References:

  1. FDA. FDA proposes ban on most powdered medical gloves [press release]. March 21, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466.htm.
  2. FDA. FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death [press release]. March 22, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm.
  3. FDA. FDA approves new treatment for inhalation anthrax [press release]. March 21, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491470.htm.