"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

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.

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.

Direct-to-Consumer Prescription Drug Advertising

1999 ◽  
Vol 25 (1) ◽  
pp. 149-167
Author(s):  
Tamar V. Terzian
Keyword(s):  
Prescription Drug ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmaceutical Products ◽  
Drug Advertising ◽  
Direct To Consumer ◽  
Prescription Drug Advertising ◽  
Adequate Provision ◽  
Package Labeling ◽  
Made In

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products. The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made “in connection with the broadcast presentation,” if the brief summary is not also part of the advertisement. Under the FDCA, the brief summary provides information concerning the major risks of the drug.

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.

Doxapram and Potential Benzyl Alcohol Toxicity: A Moratorium on Clinical Investigation?

PEDIATRICS ◽  
1986 ◽  
Vol 78 (3) ◽  
pp. 541-541
Author(s):  
DAVID JACKSON
Keyword(s):  
Benzyl Alcohol ◽  
Drug Administration ◽  
Potential Risk ◽  
Clinical Investigation ◽  
Food And Drug Administration ◽  
Premature Newborns

In Reply.— We read with interest and due concern the letter of Dr Jordan et al about the potential risk of benzyl alcohol toxicity in premature newborns who received infusions of Dopram Injectable (containing benzyl alcohol 0.9% as a preservative) for treatment of apnea. In May 1982, the Food and Drug Administration issued a "Dear Doctor" letter and, in August 1982, published an article in the FDA Drug Bulletin raising concerns about the use of solutions containing benzyl alcohol or other prcservatives in treating newborns.

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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