Do You Remember E-Ferol? The Penalty for Selling Untested Drugs in Neonatology: Fines and a Jail Sentence

PEDIATRICS ◽  
1992 ◽  
Vol 89 (1) ◽  
pp. 159-159
Author(s):  
Jerold F. Lucey
Keyword(s):  
Vitamin E ◽  
Side Effects ◽  
Intravenous Vitamin ◽  
First Time

The most recent therapeutic disaster in neonatology occurred in 1984 when E-Ferol killed at least 38 newborns.1 It's not the first time that this kind of thing has happened. Let's hope it will be the last. Previous iatrogenic disasters have been caused primarily by well-intentioned physicians using logical therapies which turned out to have unexpected, lethal side effects. The E-Ferol chapter was a different story. A poorly managed, avaricious company, O'Neil, Jones and Feldman, Inc, a subsidiary of Carter-Glogau, decided to get the jump on the market and sell an untested preparation of intravenous vitamin E. The physicians assumed it had been tested and approved for use.

scholarly journals Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110026
Author(s):  
Chinar R. Parikh ◽  
Jaya K. Ponnampalam ◽  
George Seligmann ◽  
Leda Coelewij ◽  
Ines Pineda-Torra ◽  
...  
Keyword(s):  
Side Effects ◽  
Clinical Efficacy ◽  
Inflammatory Arthritis ◽  
Biologic Agents ◽  
Adult Patients ◽  
Therapeutic Drug ◽  
Biologic Drugs ◽  
Therapeutic Implications ◽  
The Impact ◽  
First Time

The treatment of inflammatory arthritis has been revolutionised by the introduction of biologic treatments. Many biologic agents are currently licensed for use in both paediatric and adult patients with inflammatory arthritis and contribute to improved disease outcomes compared with the pre-biologic era. However, immunogenicity to biologic agents, characterised by an immune reaction leading to the production of anti-drug antibodies (ADAs), can negatively impact the therapeutic efficacy of biologic drugs and induce side effects to treatment. This review explores for the first time the impact of immunogenicity against all licensed biologic treatments currently used in inflammatory arthritis across age, and will examine any significant differences between ADA prevalence, titres and timing of development, as well as ADA impact on therapeutic drug levels, clinical efficacy and side effects between paediatric and adult patients. In addition, we will investigate factors associated with differences in immunogenicity across biologic agents used in inflammatory arthritis, and their potential therapeutic implications.

Unusual Syndrome Among Premature Infants: Association With a New Intravenous Vitamin E Product

PEDIATRICS ◽  
1985 ◽  
Vol 75 (3) ◽  
pp. 598-602
Author(s):  
Vichien Lorch ◽  
M. Dianne Murphy ◽  
Linda R. Hoersten ◽  
Eva Harris ◽  
Jean Fitzgerald ◽  
...  
Keyword(s):  
Renal Failure ◽  
Vitamin E ◽  
Premature Infants ◽  
Significant Risk ◽  
Significant Risk Factor ◽  
The Other ◽  
Intensive Care Nursery ◽  
Symptom Complex ◽  
Intravenous Vitamin ◽  
Unusual Symptom

Eight small, premature infants developed an unusual symptom complex of pulmonary deterioration, thrombocytopenia, liver failure, ascites, and renal failure. five infants died; the health of the other three infants improved and they were discharged from the hospital. This unusual syndrome occurred after introduction of a new intravenous vitamin E product (E-Ferol, α-tocopherol acetate) for routine use in the intensive care nursery. Even though no definite conclusion was reached as to its cause, the administration of this intravenous vitamin E product appears to be a significant risk factor.

Targeting vitamin E TPGS–cantharidin conjugate nanoparticles for colorectal cancer therapy

RSC Advances ◽  
2015 ◽  
Vol 5 (66) ◽  
pp. 53846-53856 ◽  
Author(s):  
Shihou Sheng ◽  
Tao Zhang ◽  
Shijie Li ◽  
Jun Wei ◽  
Guangjun Xu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Drug Delivery ◽  
Vitamin E ◽  
Chinese Medicine ◽  
Side Effects ◽  
Cancer Therapy ◽  
Traditional Chinese Medicine ◽  
Drug Efficacy ◽  
Vitamin E Tpgs ◽  
Colorectal Cancer Cells

A traditional Chinese medicine cantharidin which was previously found to be effective on colorectal cancer cells was translated into nanoparticles for drug delivery to reduce its side effects and enhance its drug efficacy.

Morbidity and Mortality Among Low Birth Weight Infants Exposed to an Intravenous Vitamin E Product, E-Ferol

PEDIATRICS ◽  
1989 ◽  
Vol 83 (2) ◽  
pp. 244-249
Author(s):  
Janet B. Arrowsmith ◽  
Gerald A. Faich ◽  
Dianne K. Tomita ◽  
Joel N. Kuritsky ◽  
Franz W. Rosa
Keyword(s):  
Intensive Care ◽  
Birth Weight ◽  
Vitamin E ◽  
Low Birth Weight ◽  
Intensive Care Units ◽  
Neonatal Intensive Care ◽  
Morbidity And Mortality ◽  
Neonatal Intensive Care Units ◽  
Low Birth Weight Infants ◽  
Intravenous Vitamin

In April 1984, the US FDA was notified of an unusual clinical syndrome consisting of ascites, liver and renal failure, thrombocytopenia, and death among low birth weight infants exposed to an intravenous vitamin E preparation, E-Ferol. The product, which had not been tested for safety prior to marketing, was voluntarily withdrawn from the market in early April. To further investigate the reported associations, the FDA conducted a retrospective cohort study among seven neonatal intensive care units where the product had been used. Standardized abstraction forms were completed for infants admitted to a unit between Nov 1, 1983, and April 30, 1984. Included in the study were 379 infants weighing 2,000 g or less and surviving at least two days; 148 (39%) had been exposed to E-Ferol. Compared with the unexposed infants, the exposed infants were more likely to die and to have ascites, hepatomegaly, thrombocytopenia, and a combination of clinical events similar to the syndrome initially reported. We conclude that the use of E-Ferol in these neonatal intensive care units was associated with increased morbidity and mortality among exposed infants.

Preoperative antioxidant and allopurinol therapy for reducing reperfusion-induced injury in patients undergoing cardiothoracic surgery

1996 ◽  
Vol 16 (6) ◽  
pp. 69-73
Author(s):  
LC Simko ◽  
JH Walker
Keyword(s):  
Clinical Trials ◽  
Vitamin E ◽  
Side Effects ◽  
Vitamin C ◽  
Postoperative Period ◽  
Myocardial Cells ◽  
Medication Regimen ◽  
Short Term ◽  
Adverse Side Effects ◽  
The Cost

Administration of vitamin E, vitamin C, and allopurinol to reduce reperfusion-induced injury remains controversial. Clinical trials are being conducted, and the results are promising. No adverse side effects have been reported with the short-term use of these drugs. The cost of the pre-operative medication is approximately $5 per week, which favors its use. The ability of nurses to be effective advocates of patients receiving these drugs is vital. What appears to be a trivial medication regimen may save myocardial cells and promote an uncomplicated postoperative period.

Toxicity Studies of Intravenous Vitamin E in Newborn Rabbits

1990 ◽  
Vol 14 (4) ◽  
pp. 231-237 ◽  
Author(s):  
Audelio Rivera ◽  
Kamal M. Abdo ◽  
John R. Bucher ◽  
Joel R. Leininger ◽  
C.A. Montgomery ◽  
...  
Keyword(s):  
Vitamin E ◽  
Toxicity Studies ◽  
Intravenous Vitamin

scholarly journals AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets

2020 ◽  
Vol 46 (5) ◽  
pp. 1038-1044 ◽  
Author(s):  
Thomas Ward ◽  
Mar Rus-Calafell ◽  
Zeyana Ramadhan ◽  
Olga Soumelidou ◽  
Miriam Fornells-Ambrojo ◽  
...  
Keyword(s):  
Side Effects ◽  
Future Development ◽  
Full Range ◽  
Therapeutic Targets ◽  
Digital Representation ◽  
Face To Face ◽  
Comprehensive Account ◽  
First Time ◽  
Therapy Delivery ◽  
Complete Account

Abstract AVATAR therapy represents an effective new way of working with distressing voices based on face-to-face dialogue between the person and a digital representation (avatar) of their persecutory voice. To date, there has been no complete account of AVATAR therapy delivery. This article presents, for the first time, the full range of therapeutic targets along with information on acceptability and potential side effects. Interest in the approach is growing rapidly and this report acts as a necessary touchstone for future development.

scholarly journals Monitoring the side effects with DSC caused by cyclophosphamide treatment

2019 ◽  
Vol 142 (2) ◽  
pp. 765-770
Author(s):  
Péter Farkas ◽  
Franciska Könczöl ◽  
Dénes Lőrinczy
Keyword(s):  
Side Effects ◽  
Red Blood Cells ◽  
Blood Cells ◽  
Peripheral Nerves ◽  
Chemotherapeutic Agents ◽  
Cyclophosphamide Treatment ◽  
Micro Dsc ◽  
Induced Changes ◽  
First Time ◽  
Dose Dependent

AbstractPolyneuropathy is defined as a simultaneous malfunction of several peripheral nerves, which could be a side effect of a cancer therapy (using cyclophosphamide) as well. In the daily use, it is very important to know the kinetics and metabolism of anticancer drugs because this way we can estimate their undesirable consequences to avoid the unwanted complications. Nowadays, the application of DSC in diagnosis of different diseases using blood compounds is increasing; therefore, the purpose of recent study was to introduce at the first time the DSC in the detection of cyclophosphamide-induced changes in plasma and red blood cells in case of an experimental animal model. Guinea pigs (Cavia porcellus, n = 60, in 12 different groups) underwent to cyclophosphamide treatment administrated intraperitoneally with the dose comparable to the human dosage. At the end of treatments, the animals were euthanized, and the experimental samples (plasma end red blood cells) were analyzed by a SETARAM Micro DSC-II calorimeter. The denaturation temperatures and the calorimetric enthalpies were calculated from the heat flow curves. Our results exhibited a dose-dependent difference between thermal parameters of untreated and treated samples, demonstrating that DSC is applicable in this field too. After deconvolution of DSC scans, the changes could be assigned to the attacked compounds. Recently published papers call the attention for this technique more frequently in the medical diagnosis because this way from small amount of sample very quickly and economically possible to detect and predict the expected and unwanted side effects of chemotherapeutic agents.

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