fbpx
July 1, 2021

FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl

For 2010 information on Risk Evaluation and Mitigation Strategy (REMS) please see the FDA Archive Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences Safety […]
July 1, 2021

FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs

(en Español) Safety Announcement [4-26-2012] The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) […]
July 1, 2021

FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays

Safety AnnouncementAdditional Information for Consumers and Parents/CaregiversAdditional Information for Health Care ProfessionalsData Summary List of ProductsReferences Safety Announcement [10-25-2012] The U.S. Food and Drug Administration (FDA) […]
July 1, 2021

FDA Drug Safety Communication: Safety Review update of Abacavir and possible increased risk of heart attack

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [03-01-2011] The U.S. Food and Drug Administration (FDA) is updating the public about […]
June 30, 2021

Public Notification: 365 SKINNY High Intensity contains hidden drug ingredient

[6-30-2021] The Food and Drug Administration is advising consumers not to purchase or use 365 SKINNY High Intensity, a product promoted and sold for weight loss […]
June 30, 2021

Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies – 06/30/2021 – 06/30/2021

On This Page Date: June 30, 2021 Time: 12:00 PM – 1:00 PM ET [embedded content] Visit CDER Small Business and Industry Assistance Safety Reporting Requirements […]
June 29, 2021

Coronavirus (COVID-19) Update: June 29, 2021

For Immediate Release: June 29, 2021 The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic: The […]
June 29, 2021

FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse

[ 06-07-2016 ] The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea […]
June 29, 2021

FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0