Podophyllum–A Dangerous Laxative

PEDIATRICS ◽  
1976 ◽  
Vol 57 (3) ◽  
pp. 419-421
Author(s):  
Gladys Rosenstein ◽  
Herman Rosenstein ◽  
Martha Freeman ◽  
Nathan Weston
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Antiemetic Drug ◽  
Review Panel ◽  
Over The Counter ◽  
Drug Products ◽  
Bilateral Absence ◽  
Independent Evaluation ◽  
Available Information ◽  
Intensive Search

A physician asked the Food and Drug Administration (FDA) for information regarding podophyllum. He had under his care an infant born with phocomelia manifested by bilateral absence of the radii. During her pregnancy, the child's mother had occasionally taken a laxative which contained podophyllum as one of its active ingredients. This inquiry led to an intensive search for available information on this subject. The discussion below is a summary of this information. From the data it was determined that podophyllum is too toxic a drug to be used as a laxative, especially since much safer laxatives are available. The FDA Advisory Review Panel on Over-the-Counter (OTC) Laxative, Antidiarrheal, Emetic and Antiemetic Drug Products, in a recently completed independent evaluation, similarly concluded that podophyllum resin is an unsafe laxative.

Comprehension Testing for OTC Drug Labels: Goals, Methods, Target Population, and Testing Environment

1998 ◽  
Vol 17 (1) ◽  
pp. 86-96 ◽  
Author(s):  
Louis A. Morris ◽  
Karen Lechter ◽  
Michael Weintraub ◽  
Debra Bowen
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Target Population ◽  
Low Literacy ◽  
Over The Counter ◽  
Testing Environment ◽  
Complex Products ◽  
Drug Products ◽  
Label Information

Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environment. The authors also examine areas in need of further research and debate. As more complex products are considered for OTC status, it is even more important to ensure that OTC labels are comprehensible. As understanding and the validity of methods to evaluate consumer comprehension improve, so should the quality of labels offered to consumers.

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.

Drugs (e.g., Hexachiorophene), the FDA, and the AAP

PEDIATRICS ◽  
1972 ◽  
Vol 50 (2) ◽  
pp. 338-338
Author(s):  
Ira Marks
Keyword(s):  
American Academy ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
American Academy Of Pediatrics ◽  
Set Up ◽  
Available Information

Although it is now six months since the Food and Drug Administration (FDA) originally approached the American Academy of Pediatrics regarding the potential dangers of hexachlorophene, the Academy (through its Committee on Fetus and Newborn) still seems to be basing its decision on three (unconfirmed) studies referred to in the FDA Bulletin of December 1971. If the Academy is to become involved in the FDA decision (and I agree that it should) is it not mandatory that we set up specific criteria that must be met before we agree or disagree with any FDA announcement? Simply because the FDA does, must we feel obliged to make decisions on the basis of a few studies which have been repeated by no one? Apparently the Committee has felt so, since it made its recommendation after "reviewing all the available information," i.e., a few unconfirmed studies.

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.

"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

scholarly journals US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised

2018 ◽  
Vol 142 (11) ◽  
pp. 1383-1387 ◽  
Author(s):  
Andrew J. Evans ◽  
Thomas W. Bauer ◽  
Marilyn M. Bui ◽  
Toby C. Cornish ◽  
Helena Duncan ◽  
...  
Keyword(s):  
United States ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Digital Pathology ◽  
The United States ◽  
Primary Diagnosis ◽  
Clinical Applications ◽  
Whole Slide Imaging ◽  
The Us ◽  
Available Information

April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.

scholarly journals Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

2012 ◽  
Vol 14 (4) ◽  
pp. 915-924 ◽  
Author(s):  
Barbara M. Davit ◽  
Mei-Ling Chen ◽  
Dale P. Conner ◽  
Sam H. Haidar ◽  
Stephanie Kim ◽  
...  
Keyword(s):  
Drug Administration ◽  
Generic Drug ◽  
Food And Drug Administration ◽  
Average Bioequivalence ◽  
Drug Products ◽  
The Us
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