Image Español April is National Minority Health Month. It’s a time to remember that health outcomes can be different among people of diverse ethnic and racial groups. These differences in health status are called health disparities. Health disparities exist for many diseases, including HIV/AIDS, hepatitis, diabetes, cancer, and heart disease. Racial and ethnic minorities may…
Seasonal Allergies: Which Medication is Right for You?
[embedded content] Español The pollen count is sky-high. You’re sneezing, your eyes are itching, and you feel miserable. Seasonal allergies are real diseases that can interfere with work, school or recreation. Allergies can also trigger or worsen asthma and lead to other health problems such as sinus infections (sinusitis) and ear infections, particularly in children….
Kefauver-Harris Amendments Revolutionized Drug Development
Image President John F. Kennedy hands Sen. Estes Kefauver the pen he used to sign the 1962 Amendments to the Federal Food, Drug and Cosmetic (FD&C) Act. Those looking on include Frances Kelsey, second from left, the FDA medical officer who refused to approve the new drug application for Kevadon, the brand name for thalidomide…
Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
[Posted 06/15/2020] AUDIENCE: Health Professional, Pharmacy, Patient ISSUE: FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but, is…
Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: June 11, 2020 FDA Publish Date: June 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) Company Name: Lupin Pharmaceuticals, Inc Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-release Tablets Company Announcement Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets…
Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell® Recall
Summary Company Announcement Date: June 01, 2020 FDA Publish Date: June 01, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Increased risk of BIA-ALCL Company Name: Allergan Aesthetics Brand Name: Brand Name(s) Product Description: Product Description Breast Implants Company Announcement Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital…
Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License…
Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: June 02, 2020 FDA Publish Date: June 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of N-Nitrosodimethylamine (NDMA) Company Name: Marksans Pharma Limited, India Brand Name: Brand Name(s) Time-Cap Labs, Inc. Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500mg Company Announcement Marksans Pharma…
Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: June 02, 2020 FDA Publish Date: June 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of N-Nitrosodimethylamine (NDMA) Company Name: Teva Pharmaceuticals USA Inc. Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg Company Announcement Teva Pharmaceuticals USA,…
Two Neuromuscular Blocking Agents: CDER Alert – FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps
[Posted 06/03/2020] AUDIENCE: Health Professional, Pharmacy, Risk Manager ISSUE: FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents, vecuronium bromide for injection, 10 mg and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL and 100 mg/10…