Two different birth control pills were recalled over a two-week period because the packages may contain an inappropriate number of placebo pills. On Aug. 27, Health Canada announced that Freya-28 was voluntarily recalled by Mylan Pharmaceuticals, which imports the oral contraceptive, after a pharmacy reported that it discovered a placebo instead of an active pill in one package. On Sept. 5, Health Canada issued another alert announcing that Mylan decided to recall Esme-28, another birth control pill, as a precaution. Both are manufactured by Famy Care Ltd, a producer of IUDs and generic contraceptive pills based in Mumbai, India.
Health Canada reported that the error “could result in reduced effectiveness for contraception, with the possibility of an unplanned pregnancy.” Consumers were told to use non-hormonal birth control until they could get other oral contraceptives, to return unopened packages to the pharmacists, and to report any unexpected reactions to Health Canada.
In April, Alysena 28, a generic oral contraceptive manufactured by Apotex, was recalled because the packaging also contained too many placebos. It resulted in an $80-million class-action lawsuit by 60 women launched in May; 40 women became pregnant and 4 had abortions. According to the Globe and Mail, Apotex was cited by the United States Food and Drug Administration for critical deficiencies at some factories and the country is threatening to stop importing from Apotex.
Canadian doctors are putting the blame on manufacturers of generics. A press release from the Society of Obstetricians and Gynaecologists of Canada states that the group “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.” The press release adds that “poor-quality birth control manufacturing leads directly to unplanned and unwanted pregnancies, which impacts men, women and children.” It links to a past release with four recommendations made by the SOGC and the College of Family Physicians of Canada after the Alysena 28 recall, including mandating that a pharmacist notify the patient and doctor if he or she substitutes the drug in a prescription for the generic version. The groups also recommend that generic drugs be identified by their medical ingredients and be forbidden from using “look-alike, sound-alike ‘brand’ names.”
Poor quality standards of generic drugs appear to only be the beginning of the problem. At least 23 Canadian women have died since 2007 due to blood clots after using the non-generic Yaz and Yasmin birth control pills manufactured by Bayer. Over half were under 26 and one was as young as 14 years old. There are two class action lawsuits underway.
Birth control pills release estrogen and progestin to mimic female hormones to stop ovulation. They may also thicken the cervical mucus to prevent the sperm from reaching the egg and alter the uterine lining, preventing implantation of the fertilized egg. Oral contraceptives, however, increase the risk of blood clots forming along the lining of blood vessels. If the clots break off and block an artery supplying a major organ such as the brain, lungs, or heart, they could prove fatal.
Yaz and Yasmin are fourth-generation birth control pills that contain a type of progestin called drospirenone, as well as estrogen. First-generation pills are thought to be more dangerous than their newer counterparts, because they contained a higher dose of estrogen, increasing the risk of developing blood clots.
Evidence indicates, however, that third- and fourth-generation birth control pills still pose significant risks. Between 2007 and 2013, 600 adverse reactions to Yaz or Yasmin were reported by doctors and pharmacists in Canada. In 2011, Health Canada issued an advisory about drospirenone-containing Yaz and Yasmin, finding that women are 1.5 to three times likelier to develop blood clots than with older birth control pills. A study by France’s health and drug safety agency, the ANSM, found that 14 of the 20 annual deaths related to birth control pills were caused by third- and fourth-generation pills.
All estrogen-progesterone and progesterone-only oral contraceptives, however, are classified by the International Agency for Research on Cancer, part of the World Health Organization, as Group 1 carcinogens, the most dangerous classification, although the entry also cites a “protective effect” of estrogen-progesterone pills against developing endometrial and ovarian cancer.
Birth control pills increase the rate of breast, cervical, and liver cancer, although there is controversy as to how much. One study led by Jessica Dolle of the Fred Hutchinson Cancer Research Centre published inCancer Epidemiology, Biomarkers & Prevention journal in 2009 discovered that birth control pill use for more than one year in women under 45 was associated with a 2.5 times increase in risk of developing deadly triple-negative breast cancer, while for those under 40, it rose to 4.2. Such findings suggest that there should be more public awareness of the dangers of oral contraceptives.
