GENERIC DRUGS INDICATED FOR USE IN PREGNANCY...ARE THEY PROPERLY TESTED?

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."

About Pregmedic
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.

SOURCE PREGMEDIC

For further information:

Betty Ann Rafuse, BScPhm, MBA
Executive Director, Pregmedic
E-mail:   barafuse@pregmedic.org
Phone: 416 558-8472

Links: www.pregmedic.org    www.sogc.org      www.motherisk.org

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