MONTREAL, May 27, 2011 /CNW Telbec/ - Pregmedic, the Canadian Alliance for the Safe and Effective Use of
Medications in Pregnancy and Breastfeeding, held its second national symposium in Montréal to discuss Clinically Relevant Pharmacokinetics Changes in Pregnancy and advocate for the revision of Health Canada's regulatory process on
bioequivalence study of drugs intended for a vulnerable special
population such as pregnant women.
A symposium panellist, Dr. André Lalonde, Executive Vice-President of
The Society of Obstetricians and Gynaecologists of Canada (SOGC),
stated that "the SOGC is concerned about the current regulations by
Health Canada on evaluating drug use in pregnancy. These concerns
especially for generic drug submissions include small number of
individuals tested (in some cases approximately 25) and the fact that
drug(s) for exclusive use in pregnancy are tested on men and women.
This can lead to serious underreporting of actions and side effects. It
is well known that drugs react differently in men and women. In the
same way that the bioequivalence of a generic drug for prostate cancer
should be studied in men only, the bioequivalence of generic drugs
aimed at pregnant women should be studied in women only."
"Presently, when a drug is intended for the treatment of pregnant women,
studies use men and/or women and are approved based on the average of
all participants. If an interaction occurs due to the sex-related
variability, the bioequivalence between a generic and its original
version cannot be assumed safe and effective. In addition, there are no
requirements to disclose to the prescribers the exact population used
in bioequivalence trials. In the coming months, the SOGC will release a
policy statement aimed at helping healthcare practitioners protect
their pregnant patients by prescribing the best treatment options
available" concluded Dr. Lalonde.
Dr. Koren, founder and Director of the Motherisk Program at the Hospital
for Sick Children in Toronto, stated that "the idea of mixing men and
women when studying the pharmacokinetics and bioequivalence of drugs
aimed at pregnant women is illogical, as it may have an impact on
dosing recommendations, effectiveness and side effects. I believe it is Health Canada's responsibility to ensure that all treatment options
to be used in pregnancy are approved based on data collected in women
only. Review of the pharmacological literature shows that sex-related
differences in pharmacokinetics and bioequivalence are apparent in many
drugs studied and may affect the conclusions about interchangeablity of
different forms of the drug."
Pregmedic, the Canadian Alliance for the Safe and Effective Use of
Medications in Pregnancy and Breastfeeding, was founded in 2007 by
representatives from health professionals, academia, patients,
regulatory and industry. Pregmedic's mandate is to advocate for
maternal/fetal and neonatal health, particularly with regards to the
safety of medications during pregnancy and breastfeeding.
For further information:
Betty Ann Rafuse, BScPhm, MBA
Executive Director, Pregmedic
Phone: 416 558-8472
Links: www.pregmedic.org www.sogc.org www.motherisk.org