Enhanced warnings for opioid pain medications

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose … Read more

ReShape balloon device to treat obesity approved in US

The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) – A new balloon device to treat obesity without the need for invasive surgery is approved by US FDA. This is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, … Read more

Praluent – alirocumab injection approved for cholesterol-lowering treatment by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults … Read more

Naegleria Fowleri Ameba in St. Bernard Parish Water System

The Louisiana Department of Health and Hospitals (DHH) confirmed the presence of the Naegleria fowleri ameba in the St. Bernard Parish Water System at the site of a leaking sampling station. The water system, which serves 44,000 residents in St. Bernard Parish, was tested by DHH as part of the State’s new public drinking water … Read more

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