Search Results for Safety Communications

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New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety By Michael Mezher - Published 09 January 2018

A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms.

Categories: News, US, FDA, Communication, Drugs

Tags: Twitter, Facebook, Social Media, Safety Communications

Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk By Zachary Brennan - Published 06 June 2016

The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach.

Categories: News, US, FDA, Over the counter drugs, Postmarket surveillance

Tags: aspirin, heartburn, OTC drug safety communications, nonprescription drugs

FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases By Zachary Brennan - Published 12 May 2016

The US Food and Drug Administration (FDA) on Thursday advised that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections (UTIs) who have other treatment options.

Categories: News, US, FDA, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Fluoroquinolone, FDA safety communications

Antipsychotic Label Updated With New Impulse-Control Side Effects Published 03 May 2016

The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals.

Categories: News, US, FDA, Drugs, Labeling

Tags: Abilify, impulse control, FDA safety communications

New Studies Push FDA to Expand Label for Popular Diabetes Drugs By Zachary Brennan - Published 08 April 2016

Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.

Categories: News, US, FDA, Drugs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: metformin, diabetes, label changes, FDA and safety communications

FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure By Zachary Brennan - Published 05 April 2016

The US Food and Drug Administration (FDA) on Tuesday updated its safety communication for Type 2 diabetes medicines containing saxagliptin and alogliptin as they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.

Categories: News, US, FDA, Compliance, Crisis management, Labeling, Regulatory intelligence, Regulatory strategy

Tags: saxagliptin, alogliptin, safety communications, Onglyza, Type 2 Diabetes