US Food and Drug Administration Black Box Warnings

2020 ◽  
Vol 110 (1) ◽  
Author(s):  
Robert G. Smith
Keyword(s):  
Adverse Effects ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Black Box ◽  
Ethical Obligation ◽  
Drug Products ◽  
Body Of Knowledge ◽  
Drug Adverse Effects ◽  
Black Box Warnings ◽  
Selection Of

Podiatric Physicians have an ethical obligation to prescribe responsibly and cautiously to diminish and minimize the growth of drug adverse effects. Clinicians who prescribe, dispense, and administer medications must be vigilant in continually reviewing new Black Box Warnings for medications they use for their patients. The safe and appropriate selection of medications and prescribing strategies are presented. First, the concept and process for these FDA black box warnings are introduced. Then, to enrich the podiatric physician's body of knowledge, several FDA boxed warnings from 27 selected drug products that may be prescribed by podiatric physicians are presented graphically as a table. Finally, strategies for safe prescribing of these drugs with boxed warnings are presented.

"Inactive" Ingredients in Pharmaceutical Products

PEDIATRICS ◽  
1985 ◽  
Vol 76 (4) ◽  
pp. 635-643 ◽  
Author(s):  
Keyword(s):  
Adverse Effects ◽  
Benzyl Alcohol ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmaceutical Products ◽  
Controlled Study ◽  
Product Label ◽  
Metabolic Complications ◽  
Drug Products ◽  
Inactive Ingredients

Pharmaceuticals often contain agents that have a variety of purposes including improvement of the appearance, bioavailability, stability, and palatability of the product. Excipients frequently make up the majority of the mass or volume of oral and parenteral drug products. These pharmaceutical adjuvants are usually considered to be inert and do not add to or affect the intended action of the therapeutically active ingredient. Some 773 chemical agents have been approved by the Food and Drug Administration for use as inactive ingredients in drug products.1 Inasmuch as these compounds are classified as "inactive," manufacturers are not presently required to list them on the product label. These ingredients are used for a variety of different purposes (Table 1). Because of the large number of these agents and their frequency of use, practicing physicians have recently become concerned about their possible physiologic effects. The increasing number of reports of adverse effects associated with pharmaceutical excipients2 has led to professional and consumer organizations formally requesting the FDA (Food and Drug Administration) to require complete disclosure on the product label of all substances contained in pharmaceuticals. Problems encountered with "inactive" ingredients, include the following. ADVERSE EFFECTS OF PHARMACEUTICAL EXCIPIENTS Benzyl Alcohol This antimicrobial agent is commonly used as a preservative in many injectable drugs and solutions. A number of neonatal deaths and severe respiratory and metabolic complications in infants have been associated with use of this agent.3-5 In a controlled study, intraventricular hemorrhage, metabolic acidosis, and increased mortality were positively correlated with substantial benzoic acid and benzyl alcohol levels in neonates.6

Anti-Anxiety Medicines and Hypnotics

2020 ◽  
pp. 85-120
Author(s):  
Arash Ansari ◽  
David N. Osser
Keyword(s):  
Adverse Effects ◽  
Clinical Characteristics ◽  
Food And Drug Administration ◽  
Mechanisms Of Action ◽  
Black Box ◽  
Abuse Potential ◽  
Brand Names ◽  
Clinical Use ◽  
Childbearing Age ◽  
Black Box Warnings

The chapter on anti-anxiety medicines and hypnotics discusses and reviews the use of benzodiazepines and barbiturates, medicines without abuse potential used for the treatments of anxiety (such as buspirone, propranolol, clonidine, prazosin, hydroxyzine, pregabalin, gabapentin, and quetiapine), as well as newer hypnotics including “z-drugs” considered for insomnia and sleep. It reviews their mechanisms of action, clinical characteristics, potential medication interactions, adverse effects, as well as their risks of dependence and misuse. It also briefly discusses complementary and alternative pharmacotherapies such as melatonin and cannabidiol. The chapter includes an in-depth discussion of the clinical use of these medications for anxiety and insomnia. It also discusses the use of anxiolytics in women of childbearing age, notably for pregnancy and breastfeeding considerations. Finally, the chapter includes a table of commonly used anti-anxiety medicines and hypnotics that includes each medicine’s generic and brand names, usual adult doses, pertinent clinical comments, black box warnings and Food and Drug Administration indications.

scholarly journals Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration

2021 ◽  
Vol 4 (12) ◽  
pp. e2136662
Author(s):  
Ashwini Sankar ◽  
Kristi M. Swanson ◽  
Jiani Zhou ◽  
Anupam Bapu Jena ◽  
Joseph S. Ross ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Black Box ◽  
The Us ◽  
Black Box Warnings

scholarly journals 2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
Adverse Effects ◽  
Global Health ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
Health Crisis ◽  
New Drug ◽  
Target Mode ◽  
The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

scholarly journals A Black Box Warning: The Marginalization of White-Collar Crime Victimization

2019 ◽  
Vol 1 (1) ◽  
pp. 24-33 ◽  
Author(s):  
Mary Dodge
Keyword(s):  
Drug Administration ◽  
White Collar Crime ◽  
Wide Spectrum ◽  
Food And Drug Administration ◽  
White Collar ◽  
Black Box ◽  
Additional Research ◽  
Crime Victimization ◽  
Street Level ◽  
Victimization Research

The study of white-collar crime has become a subfield of criminology receiving great attention, though victimization calls for additional research. The black box warning, used by the Food and Drug Administration to denote potential serious hazards of a drug or device, is an apt metaphor for the neglect often associated with the identification, depth, consequences, and, at times, violent nature of white-collar crime victimization. Research on victims is evolving, though compared to street-level crime remains marginalized, despite the serious harms caused by the former. This article offers a review of what researchers have accomplished and identifies topics of concern. White-collar crime targets a wide spectrum of the population and a high number of people, but the black box of victimization demonstrates the need for research that further enhances knowledge and informs policy.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals Hydroxychloroquine

2020 ◽  
Vol 0 ◽  
pp. 1-7
Author(s):  
C. B. Sindhu ◽  
Sandhya George ◽  
Anita Sankar ◽  
Valsa Stephen
Keyword(s):  
Rheumatoid Arthritis ◽  
Systemic Lupus Erythematosus ◽  
Adverse Effects ◽  
Drug Administration ◽  
Lupus Erythematosus ◽  
Food And Drug Administration ◽  
Systemic Lupus ◽  
The Past ◽  
Related Drug

Hydroxychloroquine (HCQ) and its related drug, chloroquine, have been under use for malaria for the past 75 years. Its use for malaria, rheumatoid arthritis and systemic lupus erythematosus are Food and Drug Administration (FDA) approved. These drugs have immunomodulatory and antiviral actions. More and more indications for this drug are being explored. These drugs are still under study as possible treatments for coronavirus disease 2019 but at present FDA has revoked its emergency use authorization for these two drugs. However, in many other indications, HCQ is a valuable drug but monitoring for adverse effects is mandatory.

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Safety And Efficacy ◽  
Biological Drug ◽  
Drug Products ◽  
Fda Approval ◽  
The Us ◽  
Approval Letter

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

FDA APPROVES FIRST VACCINE TO PREVENT HEPATITIS A INFECTION

PEDIATRICS ◽  
1995 ◽  
Vol 95 (4) ◽  
pp. 578-578
Author(s):  
J. F. L.
Keyword(s):  
United States ◽  
Adverse Effects ◽  
Drug Administration ◽  
Hepatitis A ◽  
Food And Drug Administration ◽  
The United States ◽  
Liver Infection

Federal health officials yesterday licensed the first vaccine in the United States to prevent hepatitis A, a serious and common viral liver infection. The Food and Drug Administration said it gave SmithKline Beecham P.L.C. approval to sell the vaccine. The company said it would begin distributing the vaccine, Havrix, in the next several weeks. The United States was the 41st country to license Havrix. An FDA spokeswoman said the agency wanted to be sure that the vaccine caused no significant adverse effects. An estimated 1.3 million people in Europe and Asia have received Havrix since 1991.

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