We recently reported in the Journal of Infection high rates of symptomatic and asymptomatic SARS-CoV-2 infections associated with high fatality in residents across four London care homes experiencing a COVID-19 outbreak during the peak of the COVID-19 pandemic in England.

The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the quali...

The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false positive results can occur with antigen tests, including when users do not follow the instructions for use of antigen tests for the rapid detection of SARS-CoV-2. Generally, antigen tests are indicated for the quali...

May 18th, 2020 - Boxed Warning Section Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance thi...

Mar 30th, 2020 - Boxed Warning Section Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this...

Jun 15th, 2020 - Boxed Warning Section Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this...

INTRODUCTION — Clostridioides (formerly Clostridium) difficile is a spore-forming, toxin-producing, gram-positive anaerobic bacterium that causes antibiotic-associated colitis. It colonizes the human intestinal tract after the normal gut flora has been disrupted (frequently in association with antibiotic therapy). C. difficile infection (CDI) is one of the most common health care-...

Jan 11th, 2018 - Recent Major Changes Section Warnings and Precautions – Serotonin Syndrome (5.2) 1/2017 Boxed Warning Section Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 2...

Dec 4th, 2016 - Boxed Warning Section Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. Suicidal Thoughts and ...

Apr 15th, 2019 - Boxed Warning Section Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. Suicidal Thoughts and ...

INTRODUCTION — Opioids, used medically for pain relief, have analgesic and central nervous system depressant effects as well as the potential to cause euphoria. Opioid use disorder (OUD) can involve misuse of prescribed opioid medications, use of diverted opioid medications, or use of illicitly obtained heroin. OUD is typically a chronic, relapsing illness, associated with significantly increas...

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs It has been a year like no other in recent memory for public health. At the U.S. Food and Drug Administration, much of our focus has been dominated by our response to the COVID-19 pandemic. We’ve continued to make important scientific progress, with each day bringing new knowledge and understanding of the SARS-CoV-...

INTRODUCTION — Colorectal cancer (CRC) is a common and lethal cancer. Screening provides benefit because removal of premalignant adenomas can prevent CRC and removal of localized cancer may prevent CRC-related death. CRC is infrequent before age 40; the incidence rises progressively thereafter to 3.7/1000 per year by age 80 (figure 1). The lifetime incidence for patients at average risk in the ...

Feb 19th, 2018 - Boxed Warning Section Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk...

Aug 7th, 2017 - Recent Major Changes Section Warnings and Precautions, Atrophic Gastritis removed (5.2) 10/2016 Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5)                                                                                                          10/2016 Indications & Usage Section Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium ...

Oct 24th, 2016 - Recent Major Changes Section Dosage and Administration, Recommended Dosing Schedule (2.1) 12/2014 Contraindications (4)                                                                                          12/2014 Warnings and Precautions, Acute Interstitial Nephritis (5.3)                       12/2014 Indications & Usage Section Pantoprazole sodium delayed-release tablets are indicated f...

Dec 12th, 2016 - Recent Major Changes Section Warnings and Precautions, Atrophic Gastritis removed (5.2) 10/2016 Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5)                  10/2016 Indications & Usage Section Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive ...

Jul 24th, 2017 - Recent Major Changes Section Warnings and Precautions, Concomitant use of Pantoprazole with Methotrexate (5.8) 05/2012 Indications & Usage Section Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablet is a proton pump inhibitor indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Di...

Feb 13th, 2017 - PATIENT MEDICATION INFORMATION SECTION Lupin Pharmaceuticals, Inc. LUPIN LIMITED LUPIN LIMITED Bupropion Hydrochloride Bupropion Hydrochloride BUPROPION HYDROCHLORIDE BUPROPION AMMONIA CYSTEINE HYDROCHLORIDE DIBUTYL SEBACATE ETHYLCELLULOSES FERROSOFERRIC OXIDE GLYCERYL BEHENATE/EICOSADIOATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYVIN...

Apr 22nd, 2017 - Boxed Warning Section Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk...