| Journal of Clinical Pharmacology & Pharmacoepidemiology ISSN (electronic): 1916-694X |
| 2010; Volume 1; Issue 1 (January -April) |
Editorial: A new journal is out of the box
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 1-2
Alejandro A. NAVA-OCAMPO(a,b)
(a)Department of Pharmacology & Toxicology, Faculty of Medicine, University of Toronto, Toronto, Canada
(b)PharmaReasons, Toronto, Canada
Correspondence: editor.jccpe@premiumreasons.com
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 1-2
Alejandro A. NAVA-OCAMPO(a,b)
(a)Department of Pharmacology & Toxicology, Faculty of Medicine, University of Toronto, Toronto, Canada
(b)PharmaReasons, Toronto, Canada
Correspondence: editor.jccpe@premiumreasons.com
REVIEW ARTICLE: Studying the safety of dugs in pregnancy: and the gold standard is...
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 3-8
Adrienne EINARSON
The Motherisk Program, Hospital for Sick Children, Division of Clinical Pharmacology, Toronto, Canada
Corresponding author: einarson@sickkids.ca
ABSTRACT
Pregnant women are often advised not to take any medication as it might have adverse effects on the
diagnosed with a chronic illness, discontinuing their medication is not an option. Women may also require
treatment for acute illnesses, such as infections with a high fever, which may compromise the fetus if not
treated. However, studying the safety of drugs during pregnancy is fraught with limitations, mostly
because of ethical reasons, as obviously no pregnant woman is going to volunteer to participate in a
randomized controlled trial (RCT). In the absence of RCTs, which are the gold standard, we have to rely on
observational studies, which are usually in the form of case reports, case series, chart reviews, cohort
studies, case-control and nested case-control studies, and administrative database studies. In this
review, the various methods of studying drug use in pregnancy are described with their accompanying
strengths and weaknesses and supported by examples from the literature to illustrate each method. In
conclusion, it appears that a combination of methods may be used to provide evidence-based information
to assist an expecting woman, together with her health care provider, in making an informed decision as to
whether or not the use a particular drug is appropriate during pregnancy.
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 3-8
Adrienne EINARSON
The Motherisk Program, Hospital for Sick Children, Division of Clinical Pharmacology, Toronto, Canada
Corresponding author: einarson@sickkids.ca
ABSTRACT
Pregnant women are often advised not to take any medication as it might have adverse effects on the
diagnosed with a chronic illness, discontinuing their medication is not an option. Women may also require
treatment for acute illnesses, such as infections with a high fever, which may compromise the fetus if not
treated. However, studying the safety of drugs during pregnancy is fraught with limitations, mostly
because of ethical reasons, as obviously no pregnant woman is going to volunteer to participate in a
randomized controlled trial (RCT). In the absence of RCTs, which are the gold standard, we have to rely on
observational studies, which are usually in the form of case reports, case series, chart reviews, cohort
studies, case-control and nested case-control studies, and administrative database studies. In this
review, the various methods of studying drug use in pregnancy are described with their accompanying
strengths and weaknesses and supported by examples from the literature to illustrate each method. In
conclusion, it appears that a combination of methods may be used to provide evidence-based information
to assist an expecting woman, together with her health care provider, in making an informed decision as to
whether or not the use a particular drug is appropriate during pregnancy.
ORIGINAL RESEARCH : Unintentional uterine hyperactivity and perinatal outcomes following labor
induction with intravaginal administration of sustained-released dinoprostone insert
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 9-14
Hyun PARK(a), Jung Yeol HAN(b,*), Hyun Kyong AHN(b), June Seek CHOI(b), Sung Il CHO(c), E. Yadira
VELÁZQUEZ-ARMENTA(d), Alejandro A. NAVA-OCAMPO(d,e)
(a)Department of Obstetrics and Gynecology, Kangnam Cha Hospital, College of Medicine, Pochon Cha
University, Seoul, Korea; (b)The Korean Motherisk Program, Division of Maternal Fetal Medicine,
Department of Obstetrics and Gynecology, Cheil Hospital & Women’s Healthcare Center, Kwandong
University, College of Medicine, Seoul, Korea; (c)School of Public Health, Seoul National University, Seoul,
Korea; (d)PharmaReasons, Toronto, Canada; (e)Department of Pharmacology & Toxicology, Faculty of
Medicine, University of Toronto, Toronto, Canada
*Corresponding author: hanjungyeol@yahoo.com
ABSTRACT
intravaginal administration of controlled-release dinoprostone who involuntarily progressed to uterine
hyperstimulation. Methods: In a retrospective cohort study design, the perinatal outcomes of 388
pregnant women who received intravaginal administration of controlled-release dinoprostone for cervix
ripening at a community hospital were analyzed. Uterine hyperactivity was considered as present if the
cardio-tocogram registered more than 5 uterine contractions within 10 minutes at any time post-induction.
Objective: To evaluate the perinatal outcomes of pregnant women who underwent labor induction with
102) Results:developed uterine hyperactivity and 73.7% (n= 286) did not. In the former group, the
incidence of vaginal deliveries within 12 hours post-induction and cesarean sections was marginally
higher than among women who did not progress to uterine hyperactivity. However, the indications of
cesarean sections were not different between both groups. The incidence of postpartum hemorrhage and
of babies admitted to the neonatal intensive care unit was similar between groups (P >0.05).
Conclusions: Uterine hyperactivity induced by intravaginal administration of controlled-release
dinoprostone may increase the rate of cesarean sections without increasing the frequency of neonatal
adverse outcomes.
induction with intravaginal administration of sustained-released dinoprostone insert
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 9-14
Hyun PARK(a), Jung Yeol HAN(b,*), Hyun Kyong AHN(b), June Seek CHOI(b), Sung Il CHO(c), E. Yadira
VELÁZQUEZ-ARMENTA(d), Alejandro A. NAVA-OCAMPO(d,e)
(a)Department of Obstetrics and Gynecology, Kangnam Cha Hospital, College of Medicine, Pochon Cha
University, Seoul, Korea; (b)The Korean Motherisk Program, Division of Maternal Fetal Medicine,
Department of Obstetrics and Gynecology, Cheil Hospital & Women’s Healthcare Center, Kwandong
University, College of Medicine, Seoul, Korea; (c)School of Public Health, Seoul National University, Seoul,
Korea; (d)PharmaReasons, Toronto, Canada; (e)Department of Pharmacology & Toxicology, Faculty of
Medicine, University of Toronto, Toronto, Canada
*Corresponding author: hanjungyeol@yahoo.com
ABSTRACT
intravaginal administration of controlled-release dinoprostone who involuntarily progressed to uterine
hyperstimulation. Methods: In a retrospective cohort study design, the perinatal outcomes of 388
pregnant women who received intravaginal administration of controlled-release dinoprostone for cervix
ripening at a community hospital were analyzed. Uterine hyperactivity was considered as present if the
cardio-tocogram registered more than 5 uterine contractions within 10 minutes at any time post-induction.
Objective: To evaluate the perinatal outcomes of pregnant women who underwent labor induction with
102) Results:developed uterine hyperactivity and 73.7% (n= 286) did not. In the former group, the
incidence of vaginal deliveries within 12 hours post-induction and cesarean sections was marginally
higher than among women who did not progress to uterine hyperactivity. However, the indications of
cesarean sections were not different between both groups. The incidence of postpartum hemorrhage and
of babies admitted to the neonatal intensive care unit was similar between groups (P >0.05).
Conclusions: Uterine hyperactivity induced by intravaginal administration of controlled-release
dinoprostone may increase the rate of cesarean sections without increasing the frequency of neonatal
adverse outcomes.
ORIGINAL RESEARCH: Trends in prescription claims following the withdrawal of rofecoxib from the
Canadian market
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 15-23
Olivier DESJARDINS, Jennifer MANLEY, Natasha NANWA, Y. Ingrid GOH, Ryan SMITH, Thomas R.
EINARSON
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
*Corresponding author: t.einarson@utoronto.ca
ABSTRACT
Objective: Rofecoxib (Vioxx, MK996) was voluntarily removed from the Canadian market by Merck in
September 2004. No studies have examined the impact of its removal on utilization of other NSAIDs. We
examined the utilization (i.e., numbers of claims) of NSAIDs, proton pump inhibitors (PPIs) and salicylic
acid derivatives (SADs) in Ontario and Québec one year prior to and after rofecoxib’s withdrawal from the
Canadian market. Methods: Monthly claims of coxibs occurring between October 2003 and November
2005 were obtained from Brogan Inc. NSAIDs were analyzed as a group and by chemical class.
Interrupted time series (segmented regression) was used to examine changes in utilization of other
coxibs, COX-1 NSAIDs, PPIs and SADs after rofecoxib’s removal. Results: Segmented regression
analysis revealed that the monthly number of claims for all NSAIDs (including coxibs) decreased by 19%,
from 622,347 to 500,397 between October 2003 and November 2005. We also identified a marked
reduction for all NSAIDs between September 2004 and January 2005 (-141,524 claims/month; 95%CI
-188,889 to 94,159; P <0.001). Monthly coxibs claims decreased after rofecoxib’s withdrawal (-156,883
claims/month; 95%CI= 184,393 to -129,373; P <0.001). Non-selective COX-1 inhibitors exhibited the
opposite trend; monthly claims increased 32% to 414,813 at study end. No shift in utilization of PPIs or
SADs was observed. Conclusions: The removal of rofecoxib from the Ontario and Québec markets
resulted in an immediate decrease followed by a slow increase in all NSAID claims.
Canadian market
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 15-23
Olivier DESJARDINS, Jennifer MANLEY, Natasha NANWA, Y. Ingrid GOH, Ryan SMITH, Thomas R.
EINARSON
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
*Corresponding author: t.einarson@utoronto.ca
ABSTRACT
Objective: Rofecoxib (Vioxx, MK996) was voluntarily removed from the Canadian market by Merck in
September 2004. No studies have examined the impact of its removal on utilization of other NSAIDs. We
examined the utilization (i.e., numbers of claims) of NSAIDs, proton pump inhibitors (PPIs) and salicylic
acid derivatives (SADs) in Ontario and Québec one year prior to and after rofecoxib’s withdrawal from the
Canadian market. Methods: Monthly claims of coxibs occurring between October 2003 and November
2005 were obtained from Brogan Inc. NSAIDs were analyzed as a group and by chemical class.
Interrupted time series (segmented regression) was used to examine changes in utilization of other
coxibs, COX-1 NSAIDs, PPIs and SADs after rofecoxib’s removal. Results: Segmented regression
analysis revealed that the monthly number of claims for all NSAIDs (including coxibs) decreased by 19%,
from 622,347 to 500,397 between October 2003 and November 2005. We also identified a marked
reduction for all NSAIDs between September 2004 and January 2005 (-141,524 claims/month; 95%CI
-188,889 to 94,159; P <0.001). Monthly coxibs claims decreased after rofecoxib’s withdrawal (-156,883
claims/month; 95%CI= 184,393 to -129,373; P <0.001). Non-selective COX-1 inhibitors exhibited the
opposite trend; monthly claims increased 32% to 414,813 at study end. No shift in utilization of PPIs or
SADs was observed. Conclusions: The removal of rofecoxib from the Ontario and Québec markets
resulted in an immediate decrease followed by a slow increase in all NSAID claims.
ORIGINAL RESEARCH: Paternal exposure to irbesartan coadministered with multiple antihypertensive
and antidiabetic drugs: a case report of a baby born healthy
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 24-26
Soon Cheol HONG(a,b), Jung Yeol HAN(a,c*), June Seek CHOI(a,c), Hyun Kyong AHN(a,c), E. Yadira
VELÁZQUEZ-ARMENTA(d), Alejandro A. NAVA-OCAMPO(d,e)
(a)The Korean Motherisk Program, (b)Division of Maternal Fetal Medicine, Department of Obstetrics and
Gynecology, Korea University Medical Center, (c)Division of Maternal Fetal Medicine, Department of
Obstetrics and Gynecology,Cheil Hospital & Women’s Health-Care Center, Kwandong University College
of Medicine, Seoul, Korea; (d)PharmaReasons, Toronto, Canada; (e)Department of Pharmacology &
Toxicology, Faculty of Medicine, University of Toronto, Toronto, Canada
*Corresponding author: hanjungyeol@yahoo.com
ABSTRACT
antihypertensive and antidiabetic drugs. Case: The baby was conceived by in vitro fertilization with an
egg obtained from a woman with untreated diabetes and hypertension and the sperm from a male with
type-2 diabetes and hypertension. At the time of sperm donation, he was taking irbesartan 150 mg d-1 in
addition to amlodipine, aspirin, carvedilol, glibenclamide, hydrochlorothiazide, metformin, ramipril, and
triazolam. At 38 weeks gestation, a 3,090 g female baby was delivered by cesarean section due to To
report the fetal outcome of a baby with paternal exposure to irbesartan and other Objective:
antihypertensive and antidiabetic drugs. Case: The baby was conceived by in vitro fertilization with an
egg obtained from a woman with untreated diabetes and hypertension and the sperm from a male with
type-2 diabetes and hypertension. At the time of sperm donation, he was taking irbesartan 150 mg d-1 in
addition to amlodipine, aspirin, carvedilol, glibenclamide, hydrochlorothiazide, metformin, ramipril, and
Objective: To report the fetal outcome of a baby with paternal exposure to irbesartan and other
antihypertensive and antidiabetic drugs. Case: The baby was conceived by in vitro fertilization with an
egg obtained from a woman with untreated diabetes and hypertension and the sperm from a male with
type-2 diabetes and hypertension. At the time of sperm donation, he was taking irbesartan 150 mg d-1 in
addition to amlodipine, aspirin, carvedilol, glibenclamide, hydrochlorothiazide, metformin, ramipril, and
triazolam. At 38 weeks gestation, a 3,090 g female baby was delivered by cesarean section due to To
report the fetal outcome of a baby with paternal exposure to irbesartan and other placenta previa. At 40
months postnatal age, the baby was 18 kg with normal growth and development. Conclusion: This case
suggests that paternal exposure to irbesartan as part of a combination therapy with other
antihypertensive drugs and antidiabetics, does not alter sperm cells or increase the risk for fetal
malformations.
and antidiabetic drugs: a case report of a baby born healthy
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (1): 24-26
Soon Cheol HONG(a,b), Jung Yeol HAN(a,c*), June Seek CHOI(a,c), Hyun Kyong AHN(a,c), E. Yadira
VELÁZQUEZ-ARMENTA(d), Alejandro A. NAVA-OCAMPO(d,e)
(a)The Korean Motherisk Program, (b)Division of Maternal Fetal Medicine, Department of Obstetrics and
Gynecology, Korea University Medical Center, (c)Division of Maternal Fetal Medicine, Department of
Obstetrics and Gynecology,Cheil Hospital & Women’s Health-Care Center, Kwandong University College
of Medicine, Seoul, Korea; (d)PharmaReasons, Toronto, Canada; (e)Department of Pharmacology &
Toxicology, Faculty of Medicine, University of Toronto, Toronto, Canada
*Corresponding author: hanjungyeol@yahoo.com
ABSTRACT
antihypertensive and antidiabetic drugs. Case: The baby was conceived by in vitro fertilization with an
egg obtained from a woman with untreated diabetes and hypertension and the sperm from a male with
type-2 diabetes and hypertension. At the time of sperm donation, he was taking irbesartan 150 mg d-1 in
addition to amlodipine, aspirin, carvedilol, glibenclamide, hydrochlorothiazide, metformin, ramipril, and
triazolam. At 38 weeks gestation, a 3,090 g female baby was delivered by cesarean section due to To
report the fetal outcome of a baby with paternal exposure to irbesartan and other Objective:
antihypertensive and antidiabetic drugs. Case: The baby was conceived by in vitro fertilization with an
egg obtained from a woman with untreated diabetes and hypertension and the sperm from a male with
type-2 diabetes and hypertension. At the time of sperm donation, he was taking irbesartan 150 mg d-1 in
addition to amlodipine, aspirin, carvedilol, glibenclamide, hydrochlorothiazide, metformin, ramipril, and
Objective: To report the fetal outcome of a baby with paternal exposure to irbesartan and other
antihypertensive and antidiabetic drugs. Case: The baby was conceived by in vitro fertilization with an
egg obtained from a woman with untreated diabetes and hypertension and the sperm from a male with
type-2 diabetes and hypertension. At the time of sperm donation, he was taking irbesartan 150 mg d-1 in
addition to amlodipine, aspirin, carvedilol, glibenclamide, hydrochlorothiazide, metformin, ramipril, and
triazolam. At 38 weeks gestation, a 3,090 g female baby was delivered by cesarean section due to To
report the fetal outcome of a baby with paternal exposure to irbesartan and other placenta previa. At 40
months postnatal age, the baby was 18 kg with normal growth and development. Conclusion: This case
suggests that paternal exposure to irbesartan as part of a combination therapy with other
antihypertensive drugs and antidiabetics, does not alter sperm cells or increase the risk for fetal
malformations.
®
PDF eBook MHTML
PDF eBook MHTML
PDF eBook MHTML
PDF eBook MHTML
PDF eBook MHTML
| All rights are reserved, and other than private or academic use, no part of the publication may be reproduced, stored, transmitted, or disseminated in any form or by any means for commercial purposes without prior written permission from the publisher. |