OTTAWA, September 6, 2013 (LifeSiteNews.com) – Health Canada issued another recall of the contraceptive Esme-28.
This follows last week's recall of the Freya-28 contraceptive pill imported by Mylan Pharmaceuticals,
In the recall notice, Health Canada said the recall came after the company announced “it was unable to rule out the possibility that Esme-28 was impacted by the same packaging issue involving Freya-28.”
Freya-28 was recalled after complaints that placebo pills were found in place of pills with the active contraceptive drugs in some packages.
Health Canada warns that the mistake “could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy.”
The health agency advised users of both Esme-28 and Freya-28 to return unopened packages to their pharmacy and use a “non-hormonal method of birth control.”
The Canada-wide Esme-28 recall affects 10,295 cartons, or about 430,000 packages of the drug, said Nina Devlin, vice president of Global Communications for Mylan, to CBC News.
Both Esme-28 and Freya-28 brand pills are produced by Famy Care Ltd, a manufacturer of intrauterine contraceptive devices (IUDs) and generic oral contraceptive pills based in Mumbai, India.
Mylan Pharmaceuticals imports and distributes the generic contraceptive drugs in Canada under various brand names.
This is the third time this year that Health Canada has issued warnings about faulty contraceptive drugs.
In April, Health Canada recalled the birth control pill Alysena 28, manufactured by Apotex, after packages were mistakenly issued with placebos.
In May, a group about 60 Canadian women launched an $800-million class action lawsuit against Apotex after sex while using the faulty pill resulted in pregnancy.
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Lawyers at Watkins Law Professional Corporation said that 40 women are pregnant while other women have stepped forward to join the class action.
Four women reportedly opted to abort their babies.
The U.S. Food and Drug Administration has cited Apotex for critical deficiencies at some of its manufacturing plants. The U.S. health agency threatened to halt imports from the company as a result, according to a Globe and Mail report.
The International Agency for Research on Cancer (IARC), a division of the World Health Organization (WHO) classifies the oral contraceptive pill as a Group 1 carcinogen, the most dangerous classification for cancer causing substances.
IARC declared that, “Previously, combined oral contraceptives had been determined to be carcinogenic to humans, but only primary liver cancer was specifically implicated. The Working Group concluded that combined oral contraceptives alter the risk of several common cancers in women. They increase a woman’s risk of cervical cancer, breast cancer, and liver cancer.”
Jennifer Blake, chief executive of the Society of Obstetricians and Gynecologists of Canada, said the recurring recall of contraceptive drugs poses a serious concern over both the quality and safety of the drugs, and the ability of Health Canada to oversee quality-control and safety of medicines sold to Canadians.
“The Society of Obstetricians and Gynecologists of Canada is appalled that generic birth control pills do not appear to meet the same rigorous manufacturing standards that we have come to expect of pharmaceuticals in Canada,” said Blake in a press release.
“It is unacceptable that any birth control pills could be manufactured for the Canadian marketplace without adequate quality control.”
Dr. Francine Lemire, executive director and CEO of the College of Family Physicians of Canada (CFPC) stated that, “It is imperative that Health Canada put in place an open, transparent system that will restore the confidence of the Canadian public.”