FDA - Food and Drug Administration Archives - Consumer Justice Foundation

Category: FDA – Food and Drug Administration

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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New Testosterone Therapy Warnings

March 5, 2015

FDA Adds New Heart Attack, Stroke Warnings to Testosterone Drugs

New FDA warnings must be added to the labels of low-T drugs that include the risk of side effects like heart attack, stroke and sudden death.

Federal drug regulators are requiring stronger warnings regarding the potential risk of side effects like…

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Problems With Xarelto Studies

March 3, 2015

Xarelto Studies May Have Contained Falsified Data About Safety Risks

Researchers may have falsified and destroyed information about the risk of uncontrollable bleeding side effects of Xarelto.

According to a recent report on clinical trial misconduct, there may have been problems with at least one early study on the safety of…

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Zofran Birth Defect Risk

February 9, 2015

Zofran Anti-Nausea Drug for Morning Sickness Linked to Severe Birth Defects in Babies

Women who take the anti-nausea drug Zofran while pregnant may have double the risk of giving birth to babies with severe birth defects.

A powerful medication designed to combat the nausea and vomiting symptoms associated with surgery and…

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