Vladimir Gavrilov MD, Matitiahu Lifshitz MD, Jacob Levy MD and Rafael Gorodischer MD
Background: Many medications used for children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efficacy. As a result, the majority of children admitted to hospital wards receive medications outside the terms of their license (off-label) or medications that are not specifically licensed for use in children (unlicensed). The extent of unlicensed and off-label medication use in ambulatory children is unknown.
Objective: To determine the extent of unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel.
Patients and Methods: We conducted a retrospective analysis of the medical records of 132 outpatient children treated in the General Pediatrics Ambulatory Unit of the Soroka Medical Center, Beer Sheva, in November–December 1998.
Results: The children’s ages ranged from 1 month to 18 years (mean ± SD 50±58 months). Of the 222 prescriptions given to these children, one-third were unlicensed (8%) or unlabeled (26%). Different dose and age were the most common categories of off-label medication use. All 18 cases of unlicensed use were due to modifica-tion of licensed drugs (tablets were crushed to prepare suspensions). Altogether, 42% of children received medicines that were off-label and/or unlicensed.
Conclusions: More off-label than unlicensed medications were used. Further investigations are required to establish the extent of unproved drug use in both hospitalized and ambulatory pediatric patients in Israel. Recommendations recently issued by the Ministry of Health’s National Council for Child Health and Pediatrics constitute a first step in the Israeli contribution to the international effort demanding testing of medications for children.
Aharon Klar MD, Eva Gross-Kieselstein MD, Gila Shazberg MD, Talia Israeli MD, Shoshana Revel-Vilk MD and Haggit Hurvitz MD
Background: Concomitant bacterial and viral infection is a well-known phenomenon, however only very rarely has a bacterial infection been reported during hepatitis A virus infection.
Objective: To evaluate retrospectively the clinical records of children hospitalized with HAV infection for a concomitant infection proved or presumed to be bacterial.
Method: A retrospective study was conducted on all the children hospitalized with hepatitis A infection from 1988–96 in our center. The records were evaluated for a concomitant infection.
Results: Of 40 children hospitalized with HAV infection, 13 were found to have a concomitant infection: these included 6 with pneumonia, 4 with pyelonephritis and 1 case each of purulent otitis media, osteomyelitis and staphylococcal bacteremia.
Conclusion: In areas where hepatitis A is endemic, a simultaneous infection with hepatitis A and other common bacterial infection during childhood may co-exist. A permissive role for HAV infection is suggested.
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HAV = hepatitis A virus
Tzipora C. Falik-Zaccai MD, Elena Shachak MSc, Devora Abeliovitch PhD, Israela Lerer MSc, Ruth Shefer MD, Rivka Carmi MD, Liat Ries MSc, Moshe Friedman MD, Mordechai Shohat MD and Zvi Borochowitz MD
Background: Achondroplasia is the most frequent form of disproportionate short stature, characterized by rhizomelic shortening of the limbs. This disorder is inherited as an autosomal dominant trait, although most of the cases are sporadic, a result of a de novo mutation. A recurrent glycine to arginine mutation at codon 380 (G380R) in the transmembrane domain of the fibroblast growth factor receptor 3 gene was found to cause achondroplasia among different populations. This is most uncommon in other autosomal dominant genetic diseases.
Objectives: To determine whether this mutation is also common among Jewish patients from diverse ethnic groups and among the Arab population in Israel.
Methods: We examined the G380R mutation (G>A and G>C transition) and the mutation G375C (G>T transition at codon 375) in 31 sporadic patients and in one family diagnosed clinically to have achondroplasia.
Results: We found the G>A transition at codon 380 in 30 of our patients and the G>C transition in one patient. We were not able to detect any of the three mutations in two patients with an atypical form of achondroplasia.
Conclusions: Our results further support the unusual observation that nucleotide 1138 of the FGFR3 gene is the most mutable nucleotide discovered to date across different populations.
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FGFR3 = fibroblast growth factor receptor 3
Menachem Nahir, MD and Yonathan Hassin, MD, PhD
Hana Strul, MD and Nadir Arber, MD
Tomas Kozak, MD, Eva Havrodova, MD, PhD and Jira Pitha, MD
Meir Shinitzky, PhD and Yechiel Goldman, PhD
Peter Lambrecht, MD, Andreas Trabandt, MD and Wolfgang L. Gross, MD
Sigal Sviri, MD, Mordechai Muszkat, MD, Michael Y. Shapira, MD, David Gross, MD and David M. Linton, MD
Deborah C. Segal, MD, Oded Vofsi, MD and Yeshayahu Katz, MD, DSc
Shlomi Codish, MD, Mahmoud Abu-Shakra, MD, Roman Depsames, MD, Neta Sion-Vardy, MD, Dan Benharroch, MD and Shaul Sukenik, MD