FDA Calls for Immediate Removal of All Zantac, Ranitidine Products from the Market
April 2, 2020
The U.S. Food and Drug Administration (FDA) announced this
week that it is asking manufacturers of Zantac and generic ranitidine products to
withdraw all prescription and over-the-counter (OTC) versions of the drug from
the market immediately. The FDA’s decision is the latest step in an ongoing
investigation into the presence of… Read More>
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Asbestos Contamination Concerns Prompt Government Experts to Urge New Talc Testing Standards
January 15, 2020
A panel of experts convened by the U.S. Food and Drug Administration
(FDA) is calling for the implementation of new testing standards and safety
parameters for talc-based products, amid concerns about the potential for these
products to be contaminated with asbestos and expose users to a risk of cancer.
The recommendations,… Read More>
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Nuplazid Patient Deaths
April 14, 2018
Reports of Deaths Linked to Parkinson’s Disease Psychosis Drug Spark Safety Concerns
Hundreds of patients have died while taking Nuplazid, a drug manufactured by San Diego-based Acadia Pharmaceuticals to control psychosis related to Parkinson’s disease, a debilitating movement disorder that affects hundreds of thousands of individuals and has a typical…
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Essure Black Box Warning
March 2, 2016
FDA Requires New Black Box Warning on Essure Contraceptive Label
After more than 5,000 women have filed adverse event reports with the U.S. Food and Drug Administration (FDA) alleging devastating complications from Essure, the FDA is finally requiring a new “black box” warning for the permanent contraceptive device to “call…
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Vaginal Mesh a High-Risk Device
January 5, 2016
FDA Issues High-Risk Warning for Transvaginal Mesh Devices
The U.S. Food and Drug Administration (FDA) has finally responded to calls for stronger warnings on the use of transvaginal mesh, reclassifying mesh devices marketed for the transvaginal repair of pelvic organ prolapse (POP) as class III high-risk devices. According to its…
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Chantix Seizure Warnings
March 11, 2015
FDA Adds New Warnings to Chantix Label Regarding Seizures, Alcohol Effects
People taking Chantix to quit smoking may be at risk for seizures, alcohol intolerance and other serious side effects.
Despite recent efforts by Pfizer to reduce warning requirements for its smoking cessation drug Chantix, the FDA announced this week that…
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